2014 News Briefs - International Neuromodulation Society

 
 

Earlier News:

Later News:



January - September 2014

Survey Finds Functional Connectivity of Brain-Stimulation Targets

Sept. 29, 2014 - Looking at correlations in spontaneous brain activity shown in a database of MRI images, researchers have shown that deep brain stimulation affects brain circuits in higher brain regions, and the maps of those effects match maps showing effects of non-invasive brain stimulation for 14 different conditions, from Parkinson's disease to dystonia and Tourette syndrome. The authors of this analysis of functional connectivity data believe it will suggest stimulation approaches for more conditions. (Medical Daily)

Researchers Pursue a Variety of Implants to Augment Lost Vision

Sept. 29, 2014 - An article describes different implant locations and powering systems for retinal prostheses under development. (The Scientist)

Brain Scans Find Differences in Inhibitory Neurotransmitters in Patients with Tourette Motor Tics

Sept. 25, 2014 - A tic disorder specialist hopes to test the effect of transcranial direct current stimulation in Tourette syndrome, reasoning that the stimulation may boost GABA that would dampen the propensity for tics. This theory is supported by the recently reported finding in Current Biology that GABA is elevated in the supplementary motor area of brains of teens who have Tourette syndrome, compared to those who don't. (Everyday Health)

Preclinical Work in Neuroprosthetics for Paralysis Demonstrates Real-Time Control of Gait

Sept. 24, 2014 - Researchers who are planning a clinical trial with closed-loop robot-assisted stimulation in paralyzed patients report success in a rat model using a self-adjusting computational system so that electrical pulse width, amplitude and frequency need not be manually adjusted in real time for each individual. The animals showed fluid, precise movement in more than 1,000 steps, including climbing stairs of varying dimensions. This development of closed-loop epidural electrical stimulation to feed electric currents to sensorimotor circuits, appears in the journal Science Translational Medicine http://stm.sciencemag.org/content/6/255/255ra133. (Medical Xpress)

Interview Looks at Neurostimulation Development for the Coming Decade

Sept. 24, 2014 - A product leader at the UK-based Cambridge Consultants discusses a recent panel report forecasting neurostimulation market factors, saying clinical appetite will need to be enhanced and a vision of the future established for developers to align with that. (Medgadget)

Medical Center in Germany Will Offer Visual Prosthetic System

Sept. 23, 2014 - EBS Technologies' Next Wave device to restore a degree of vision in conditions such as stroke, glaucoma, traumatic brain injury and some other diseases will be available at the University Medical Center Hamburg-Eppendorf. The device consists of an EEG cap and special goggles that provide optical and electrical stimulation, and an EEG amplifier linked to the goggles. The process involves stimulating the retina while energizing the optic nerve to send signals to the brain. (Medgadget)

Small Study Documents Advantages of Electrical Current Steering in Deep Brain Stimulation

Sept. 23, 2014 - A Netherlands-based study of directional current steering in deep brain stimulation in eight patients with Parkinson's disease provided Class IV evidence that steering using the 32-contact electrode was well-tolerated and increased the threshold for side effects, increasing the therapeutic window by up to 1.5 mA. (Neurology)

Physicians Report European Study of Deep Brain Stimulation in Cervical Dystonia

September 2014 - A sham-controlled clinical trial in 62 patients with cervical dystonia who received deep brain stimulation showed that three months of active pallidal neurostimulation reduced symptoms of dystonia more effectively than sham, although 16 patients had serious adverse events, generally related to the device or the implant procedure. The multicenter study, funded by Medtronic, Inc., was reported by 33 co-authors, including members of the INS German chapter Wilheim Eisner, MD; Marcus Pinsker,MD; and Karl Kiening, MD. (The Lancet)

Article Describes Program to Develop Small Devices That Might Modulate Organ Function

Sept. 19, 2014 - An article compares tiny next-generation neuromodulation devices that are envisioned by the ElectRx program, which is sponsored by the Defense Advanced Research Projects Agency, to a smart pacemaker that would assess conditions and fix vital organs with stimulus patterns tailored to help maintain healthy organ function -- giving a boost to the body's natural processes of monitoring the status of organs and managing how they respond to disease The device might be used to treat inflammatory conditions and others, such as rheumatoid arthritis and inflammatory bowel disease, epilepsy, traumatic brain injury and even depression. (Mail Online)

Clinical Trial Starts to Investigate Deep Brain Stimulation in Dementia with Lewy Bodies

Sept. 18, 2014 - The first patient has been enrolled in a six-patient clinical trial of deep brain stimulation in a type of dementia called Dementia with Lewy Bodies. Because the cognitive impairments fluctuate in the condition, it is believed the "hard wiring" functioning on days when symptoms are worse could be aided by electrical stimulation to the area that has degenerated in the condition, the nucleus basalis of Meynert. (University College London)

Company to Launch Its Latest Brain-Mapping Device That Uses Transcranial Magnetic Stimulation

Sept. 18, 2014 - A next-generation device that combines transcranial magnetic stimulation and electromyography for presurgical mapping in neurosurgery will be launched at two meetings in October. The Nexstim NBS 5 will be showcased at the 6th International Symposium on Navigated Brain Stimulation in Neurosurgery, Oct. 10 - 11 in Berlin; and at the Congress of Neurological Surgeons 64th Annual Meeting from Oct. 18 - 22 in Boston. (PR Newswire)

Low-Back-Pain Device Company Details Plans

Sept. 18, 2014 - In an interview in the Irish Independent, Mainstay Medical CEO Peter Crosby, a member of the International Neuromodulation Society, said their strategy is to build a successful global company out of the Dublin-based business whose ReActiv8 muscle-stimulating device targets low back pain. The article said that at this phase, the company is not planning to be acquired or merged as smaller companies might. (Fierce Medical Devices)

Company Says Study Confirms Potential of Nerve-Stimulation to Improve Some Vision Loss

Sept. 18, 2014 - EBS Technologies, which offers a non-invasive brain stimulation for restoring partial vision to an impaired eye, issued a news release about a study by the company's co-founder, published in Neurology, that he said "confirms that repetitive transorbital alternating current stimulation (rtACS), otherwise known as electrical brain stimulation, can reactivate residual capabilities of brain function." The study said vision loss is not only caused by primary tissue damage, but also by a breakdown of synchronization in brain networks. The stimulation aims to bring about resynchronization of alpha band coherence. (Business Wire)

Company Plans to Present Data About Preventive Vagus Nerve Stimulation in Cluster Headache

Sept. 17, 2014 - ElectroCore announced that presentations this weekend at the European Headache and Migraine Trust International Congress in Copenhagen will include data from its PREVA study, a randomized, multi-center trial across several European countries, which showed that preventative use of non-invasive vagus nerve stimulation can reduce the frequency of cluster headache attacks by 43.4% versus the current standard of care, which resulted in only a 12% reduction. (EIN News)

Spinal Cord Stimulation May Enhance Drug Delivery to Ischemic Tissue

Sept. 15, 2014 - Researchers who theorized an improvement in oxygenated blood supply would facilitate enhanced delivery of the scheduled therapy in patients with recurrent high-grade gliomas report that in seven patients in a preliminary study, spinal cord stimulation during reirradiation and chemotherapy was associated with clinical improvement and longer survival than previously reported in this condition. (Integrative Cancer Therapies)

International Neuromodulation Society Announces Abstract Competition for its June 2015 12th World Congress in Montreal

Sept. 15, 2014 - The INS is pleased to announce its best abstract competition, in which the top five abstracts for the June 2015 12th World Congress in Montreal will be recognized for their quality, originality and ingenuity in basic or clinical science. For an abstract to qualify, its primary author must be a current member of the INS who has registered for the main congress. Recipients will receive their awards during the INS General Assembly of Members on the 9th of June. In addition, the primary author recipients will be refunded their congress registration fees. To access the abstract submission system please visit http://ins-congress.abstractcentral.com/. Download the instructions for authors here. The abstract deadline is 12 January 2015. (International Neuromodulation Society)

General-Practitioner Publication Features Guidance About the Role of Neuromodulation

Sept. 15, 2014 - International Neuromodulation Society Secretary Marc Russo, MD, and INS member Nick Christelis, MD, write in a publication geared to general practitioners in Australia a perspective on the role of neuromodulation in pain management. Indications for spinal cord stimulation, they say, include spinal cord stimulation include failed back surgery syndrome, complex regional pain syndrome, peripheral neuropathic pain, chronic peripheral ischaemic pain and refractory angina pectoris. (Pain Management Today)

Comparative Study Shows Benefit of Combined Sacral Neuromodulation and Drug Therapy

Sept. 15, 2014 - A research team reports in Urology Journal that a three-month study comparing sacral neuromodulation with antimuscarinic medication to medication alone showed greater benefit from the combined therapy in 240 women with idiopathic overactive bladder. (medwire News)

Pilot Study Proposed of Deep Brain Stimulation in Combat Veterans with Post-Traumatic Stress Disorder

Sept. 10, 2014 - A U.S.-based research team proposes a Phase I clinical trial of deep brain stimulation to the basolateral amygdala to address post-traumatic stress disorder in veterans, based in part on results in a rat model of the condition. The pilot randomized controlled trial will have a blinded, staggered onset of stimulation. (Trials)

Violinist With Essential Tremor Receives Deep Brain Stimulation

Sept. 11, 2014 - A former violinist with the Lithuania national philharmonic orchestra received a deep brain stimulation implant to treat her essential tremor in Tel Aviv. She played the instrument during surgery to help pinpoint the correct stimulation, and said it was a shame she didn't know about the surgery previously, having had to stop performing years ago. (Jerusalem Post)

Failed Back Surgery Syndrome Clinical Trial Comes to Long Island

Sept. 9, 2014 - International Neuromodulation Society member Brian Snyder, MD is participating at his Long Island practice in the multicenter SENSE™ (Subcutaneous and Epidural Neuromodulation System Evaluation) clinical trial of that compares spinal cord stimulation alone, and in combination with peripheral nerve field stimulation, for the treatment of chronic low back and leg pain due to failed back surgery syndrome. (EIN Presswire)

Cancer-Related Neuropathies Affect More Than One-Third of U.S. Cancer Survivors

Sept. 4, 2014 - The Neuropathy Association released an info graphic for Pain Awareness Month that explains the impact of cancer-related neuropathy, which affects more than on-third of the 14 million cancer survivors in the U.S. (The Neuropathy Association)

Newspaper Profiles International Neuromodulation Society President

Sept. 8, 2014 - International Neuromodulation Society President Simon Thomson, MBBS, FRCA, FIPP, describes his passion for ensuring access to appropriate neurostimulation treatments in a newspaper profile highlighting his work. He started an NHS pain service more than 20 years ago after being introduced to neurostimulation in the 1980s in Australia. “People with chronic pain are more at risk of depression and social isolation," the article quotes him as saying. “Often, they can feel they are passed from pillar to post, with very little answer to what is actually causing their agony.” (Echo)

Deep Brain Stimulation Pioneers Honored with Lasker Award

September, 2014 - The 2014 Lasker-DeBakey Clinical Medical Research Award goes to Alim-Louis Benabid, MD, PhD and Mahlon DeLong, MD, whose research helped to elucidate neural circuits involved in movement disorder and demonstrate brain targets for treating motor disorder through deep brain stimulation, which has been provided to more than 100,000 patients worldwide. (Lasker Foundation)

Company Offering Neurostimulation Therapy for Reflux Files for Initial Public Offering

Sept. 5, 2014 - St. Louis, MO-based Endostim Inc. has filed for an initial public offering in an offer valued at up to $40.25 million. The company plans  to trade on NASDAQ under the symbol STIM. Endostim previously received approval in Europe, Asia and South America of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD). The company plans a U.S. clinical trial. (247wallst.com)

Psychiatrist Anticipates More Use of Neurostimulation in Psychiatry

Sept. 5, 2014 - Neurostimulation can alter both neurochemicals and aberrant neuronal activity and is likely to become more common in psychiatric treatment, according to a question-and-answer column with a psychiatrist who favors its use the treatment paradigm. He said activity of the brain is as much electrical as it is chemical, and neurostimulation poses the advantage of being somatic and non-systemic. (Psychiatric Times)

Florida Patients Have More Access to Transcranial Magnetic Stimulation for Treatment-Resistant Depression

Sept. 4, 2014 - A Florida psychiatrist who added transcranial magnetic stimulation to his practice describes how it exerts an effect by polarizing areas of the limbic system. His first patient says in an interview that the therapy leaves her feeling clearer and more revitalized, in combination with counseling. She said it had been a last resort since she could not relieve the depression she felt since childhood with medications. (USA Today)

Researchers Visualize Neuronal Effects of Transcranial Magnetic Stimulation

Sept. 4, 2014 - Researchers in Germany have published in the Proceedings of the National Academy of Sciences work that shows for the first time, in cats, high-resolution imaging of the fleeting effects of transcranial magnetic stimulation in the cortex. The time-sensitive images were captured by using voltage-sensitive dyes anchored in cell membranes. The dyes fluoresce when neurons are activated or inhibited. (Medical Xpress)

INS President Speaks Out About the Evolution of Pain Management During His Career

Sept. 3, 2014 - In an interview publicized during Pain Awareness Month, International Neuromodulation Society President Simon Thomson, MBBS, FRCA, FIPP, describes the importance of listening to patients and his efforts to continually challenge the concept that chronic pain will always have a physical cause to be repaired through surgery. (Basildon and Thurrock University Hospitals)

Los Angeles-Area Medical Center Offers Recently Approved Neurostimulation Device for Obstructive Sleep Apnea

Sept. 3, 2014 - The first medical center in Los Angeles to offer the Inspire Upper Airway Stimulation system as a neurostimulation option for obstructive sleep apnea is Keck Medicine of the University of Southern California (USC). The device received FDA approval in April. (USC News)

MIT Bioelectronics Group Works on Nanoparticle Transducers and Flexible Polymer Probes for Optical Stimulation and Electrical Sensing

Sept. 3, 2014 - A materials science professor at MIT and her research team members are pursuing creation of flexible polymer probes that have been demonstrated to optically stimulate the spinal cords of mice whose neurons were altered to respond to light, as well as magnetic materials that might be injected into the brain to serve as a transducer for neural stimulation. The work is inspired by recent findings indicating that diseases that were previously not considered to have a neurological basis, such as diabetes, hypertension and infertility, may be treated with neuromodulation by employing bioelectronic medicine. (Phys.org)

Pilot Study Demonstrates Brain-to-Brain Transmission of Coded Information

Sept. 3, 2014 - By encoding letters of words into a binary code represented by a series of motor images, scientists have transmitted two simple four-letter words recorded with non-invasive brain-monitoring -- an electroencephalogram -- in one subject and received through non-invasive brain stimulation -- robot-assisted, image-guided transcranial magnetic stimulation (TMS) -- in three other subjects. Recipients sat with eyes and ears covered and received TMS stimulation to their visual cortex. The transmissions were perceived as bright lights in their peripheral vision, with the location of the light indicating its binary code (1 or 0). The data were transmitted from the sender's system to the receiving study subjects over a distance of 5,000 miles via the Internet. (CNET)

Dystonia Patient Shows Progress After Deep Brain Stimulation

Sept. 2, 2014 - A 9-year-old boy has made progress since his deep brain stimulation one year ago for generalized dystonia. He can now independently feed himself, drink from a cup, and stand unaided. (CBS-Denver)

Epilepsy Patient Receives Closed-Loop Vagus Nerve Stimulation Implant

Sept. 2, 2014 - A man in the UK who has had up to 60 epileptic seizures per day between ages 7 months and 40 years became one of the first people in the country to add, as an adjunct to his anti-seizure medication, use of the AspireSR implant, which delivers vagus nerve stimulation to deter a seizure upon sensing a change in heart rate. Since he has seizures even while asleep, the automated sensing and response is helpful to him. (Express)

Vagus Nerve Stimulation Improved Function and Reduced Symptoms in Heart Failure Clinical Trial

Sept. 1, 2014 - The Cyberonics, Inc. ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) open-label trial of vagus nerve stimulation (VNS), conducted at multiple centers in 60 patients who had moderate to severe heart failure and impaired heart function, indicate the treatment is safe, improves the heart's ability to pump blood, and reduces symptoms associated with chronic heart failure, according to data presented at the European Society of Cardiology meeting that was concurrently published in the Journal of Cardiac Failure. Stimulation of either the right or left vagus nerve appeared to help patients achieve changes in cardiac function. While the right vagus nerve had been believed to provide more of a baroreceptor impact, the left vagus nerve may be easier to access, and surgeons are used to working on that side for implanting other cardiac devices. Presenters said the left ventricular ejection fraction increased from 32.4% to 37.2% after six months of vagus nerve stimulation system treatment. (MedPage Today)

Vagus Nerve Stimulation Clinical Trial Does Not Show Remodeling in Heart Failure, Misses Primary Efficacy Endpoint

Sept. 1, 2014 - Boston Scientific reported at the European Society of Cardiology meeting that the primary efficacy endpoint was not reached in its vagus nerve stimulation clinical trial carried out in 96 New York Heart Association Class II-III patients who had heart failure and an ejection fraction of less than 35%, the NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) trial. After six months of treatment, blinded echocardiography showed no reduction in left ventricular end systolic diameter. Control patients begin to receive active therapy after six months of randomization, with all patients followed through 18 months to assess the safety endpoint. Despite no significant effect on cardiac remodelling or functional capacity, treatment did result in significantly improved symptomatic scores in quality-of-life metrics. (Medlatest)

Authors Review Studies of Transcranial Direct Current Stimulation in Learning, Behavior, Memory, and Motor Control

Sept. 1, 2014 - Psychology researchers at the University of Queensland have reviewed an escalating number of studies utilizing transcranial direct current stimulation (tDCS) to understand cortical substrates of behavior. The authors review its application in cognitive and motor training, its use to understand neuronal activity underlying perception, learning and memory (such as fluctuations in frequency and phase), and suggest how key methodological issues might be addressed. (Cell)

Expert Ponders Path Forward for Neuromodulation for Fecal Incontinence

September 2014 - In an article listed as most-read, "Neuromodulation in an Era of Rising Need and Cost: A Time for Multifaceted Consideration," a German surgery professor and expert in coloproctology notes that posterior tibial nerve stimulation offers moderate benefit as a fecal incontinence therapy and might elicit broader acceptance of more-invasive methods such as sacral neuromodulation. He questions how access may evolve, such as who should assess needs and deliver such therapies and what the expense may be. The author calls for "the guidance and support of the relevant professional societies" to approach the issue broadly beyond any particular commercial interest. (Diseases of the Colon and Rectum)

Benefit of Spinal Cord Stimulation in Painful Diabetic Neuropathy Shown in First Randomized Controlled Clinical Trial

Aug. 29, 2014 - International Neuromodulation Society members Kaare Meier, MD, PhD, Harold Nijhuis, MD, Wim Duyvendak, MD, Thomas Enggaard, MD, PhD, and colleagues report the first multi center randomized controlled trial of spinal cord stimulation (SCS) in medically refractory painful diabetic neuropathy. Sixty patients with lower-extremity pain were enrolled. After six months, patients receiving SCS plus best medical practice had average visual-analogue-scale pain intensity scores drop from 73 to 31. Patients who did not receive SCS remained at their baseline level of pain intensity, 67, during the six-month followup. (Science Direct)

Consensus On Benefits of Constant Current Over Time in Deep Brain Stimulation

Aug. 29, 2014 - Although epilepsy treatment has already embraced constant-current deep brain stimulation (DBS) devices, there has been little reporting of constant-current DBS devices in movement and neuropsychiatric disorders. The results of a consensus meeting sponsored by the Parkinson Alliance are reported by International Neuromodulation Society member Jay Shils, PhD and colleagues. They determined that since impedance varies considerably between patients and over time and encapsulation can occur, it makes sense that all new devices will likely use constant current even if, given the potential benefits, it will be unlikely that there will be many head-to-head comparator trials. Safety will not be impacted and science supports the use of constant current even if data are lacking. (Neuromodulation: Technology at the Neural Interface)

Small Study Indicates Noninvasive Brain Stimulation Boosts Memory in Healthy Subjects

Aug. 28, 2014 - Enhancing functional connectivity and plasticity in the hippocampus of 16 healthy volunteers through five daily sessions of transcranial magnetic stimulation allowed the study subjects to improve memory-test scores by 30%, according to research at Northwestern University that appears in this week's issue of Science. (BBC News)

After Noninvasive Brain Stimulation, Healthy Volunteers Reduced Appetite and Food Consumption

Aug. 28, 2014 - Eight daily sessions of transcranial direct current stimulation (tDCS) in 14 healthy volunteers led to a 14% reduction in caloric intake from a buffet and lower appetite scores, according to research published in The American Journal of Clinical Nutrition. The National Institute of Diabetes and Digestive and Kidney Diseases has launched a clinical trial on the effects of tDCS on weight. (Newsweek)

Brain-Mapping Study Indicates Trade-Offs in Boosting Cognitive Scores

August 2014 - Neuroscientists who conducted brain-mapping at the University College London on areas responsible for numerosity and duration judgments report in the Nov. 15, 2014 issue of NeuroImage that while transcranial direct current stimulation (tDCS) improved performance in one task, it impaired performance in another. They write, "application of anodal tDCS to the left-PPC and cathodal tDCS to the right-PPC . . . increased accuracy in the numerosity judgement task and impaired accuracy in the duration judgement task, while application of anodal tDCS to the right-PPC and cathodal tDCS to the left-PPC . . . increased accuracy in the duration judgement task and impaired accuracy in the numerosity judgement task." Their findings agree with the theorem that the parietal cortex may be the primary site for common neural processing of magnitudes in the different dimensions of time, space, and quantity. However, rather than support the general consensus that neuron firing-rate is affected globally by electrical stimulation, their findings show the modulation can be selective. (Science Direct)

Company Says the FDA Has Cleared Its Manufacturing Plant

Aug. 27, 2014 - St. Jude Medical said the FDA cleared a warning letter regarding manufacturing at its Plano, Texas plant where the Eon and Eon Mini spinal cord stimulation devices are made. The company had recalled some of the devices in 2012 due to battery failures and overheating during discharge. (Mass Device)

Defense Agency Starts a Bioelectric Medicine Program

Aug. 27, 2014 - "Like a tiny, intelligent pacemaker" is how a a program manager from the Defense Advanced Research Projects Agency describes a potential future means of managing a number of challenging medical conditions through precise modulation of the peripheral nervous system. The research program, ElectRx, would develop closed-loop systems that provide stimulus patterns that help maintain healthy organ function. (Medical Design Technology)

Emerging Neuromodulation Company Files for Initial Public Offering

Aug. 26, 2014 - Los Angeles-based NeuroSigma, Inc. has registered to undergo an initial public offering. The proceeds would help to fund a pivotal trial of is external trigeminal nerve stimulation system as an adjunctive treatment for drug-resistant epilepsy, develop a second-generation system, and advance clinical studies for neuropsychiatric indications. The company also plans retire $2.4 million of debt with the proceeds. (PR Newswire)

Device Maker Acquires Developer of Deep Brain Stimulation System

Aug. 26, 2014 - Medtronic, Inc. acquired Sapiens Steering Brain Stimulation for approximately $200 million in an all-cash transaction. Sapiens is developing a deep brain stimulation system with 40 individual stimulation points that may be more precise and require a shorter procedure time. Medtronic will keep Sapiens' site in Eindhoven, The Netherlands as a research and development center for its Neuromodulation business unit. Sapiens was spun out of Philips Healthcare in 2011 as a privately held enterprise. (NASDAQ)

Therapy to Undergo Evaluation as Adjunctive Treatment for Post-Traumatic Stress Disorder

Aug. 25, 2014 - Up to 74 combat veterans will be recruited for a double-blind study of external trigeminal nerve stimulation as an adjunctive therapy in post-traumatic stress disorder at the University of California, Los Angeles. The study, funded by the U.S. Army Medical Research and Material Command, will use devices provided by the emerging company NeuroSigma, Inc. (Drug Discovery & Development)

Evolving Science of Neuromodulation Described in News Release About First Comprehensive Consensus Guidelines

Aug. 25, 2014 - International Neuromodulation Society member Robert Foreman, MD, described synergies between basic and clinical pain-therapy research in a news release about the publication of neurostimulation guidelines from the Neuromodulation Appropriateness Consensus Committee. (University of Oklahoma Health Sciences Center)

Elderly Do Not Have Significantly More Complications From Deep Brain Stimulation for Parkinson's Disease

Aug. 25, 2014 - International Neuromodulation Society member Shivanand P. Lad, MD, PhD and colleagues retrospectively reviewed 1,757 patients who underwent deep brain stimulation for Parkinson's disease between 2000 and 2009, and in a multivariate analysis, found patients older than 75 years showed a similar 90-day complication risk compared with younger counterparts. (JAMA Neurology)

Metropolitan Newspaper Covers INS Member's Public Presentation on Deep Brain Stimulation

Aug. 24, 2014 - International Neuromodulation Society member Kathryn Holloway, MD responded to questions from the public at a seminar in Richmond, VA about deep brain stimulation, Parkinson's disease, specific symptoms, timing of therapy, research and the presence of other conditions. (Richmond Times-Dispatch)

Europe, Australia Issue Patents for High-Frequency Spinal Cord Stimulation

Aug. 25, 2014 - Nevro Corp. announced it has received patents in Europe and Australia related to spinal cord stimulation with its proprietary high-frequency system that delivers electrical pulses at a rate of up to 10,000 per second (10 kHz). The stimulation differs from lower-frequency spinal cord stimulation for back and leg pain by not causing tingling from paresthesia. More patents are pending the company said. (PR Newswire)

Experts Call for Regulation of Any Use of Transcranial Direct-Current Stimulation

Aug. 23, 2014 - Transcranial direct current stimulation has attracted consumer interest for its potential to enhance some cognitive activities. In response, academics are calling for its use to be regulated, even for non-therapeutic use, such as by the do-it-yourself community of technology enthusiasts. One neurologist at Yale University comments that the "marketing is a couple of steps ahead of the science." (BBC)

France to Fund Initial Implants of Retinal Prostheses

Aug. 22, 2014 - The French Ministry of Health will fund the first wave of patients to receive the Argus II retinal prosthesis, according to the device-maker, Second Sight Medical. The company said that 36 patients will receive the devices for vision loss from retinitis pigmentosa in a contract through France's Forfait Innovation program meant to support the emergence of medical innovation. (Mass Device)

Neuromodulation Appropriateness Details Presented

Aug. 21, 2014 - The Neuromodulation Appropriateness Consensus Committee's first comprehensive guidance on the use of neurostimulation in chronic pain is reported in the online, multi-disciplinary publication Phys.org. The coverage includes details about complications and their avoidance, as reported in the peer-reviewed findings of the committee in the Aug. 2014 issue of Neuromodulation: Technology at the Neural Interface. (Phys.org)

Neuromodulation Revenues Add to Company's Quarterly Earnings

Aug. 19, 2014 - Medtronic Inc. reported first-quarter 2015 earnings with Neuromodulation and Surgical Technologies businesses offsetting declines in its Spine business, with the Restorative Therapies Group overall showing an increase of 3% on a constant currency and reported basis. The group's overall sales for the quarter were $1.603 billion. Neuromodulation revenue was up 11% on a constant currency basis or 12% as reported, totaling $479 million for the quarter. The drivers included pain stimulation, deep brain stimulation and gastroenterology/urology. The company's overall revenue was $4.273 billion, up 4% from the same quarter a year ago on a constant currency adjusted basis, or 5% as reported. (MarketWatch)

First Cluster Headache Patient Receives Sphenopalatine Ganglion Neurostimulator

Aug. 18, 2014 - International Neuromodulation Society Director-at-Large Ali Rezai, MD, was quoted in a story about the first implant of the Autonomic Technologies, Inc. neurostimulator that is undergoing a clinical trial in the U.S. in cluster headache patients. The device stimulates the sphenopalatine ganglion beneath the cheek in the upper jaw when a patient uses a hand-held controller to elicit stimulation when a cluster headache starts. Dr. Rezai said the main advantage of neurostimulation is that "it's reversible and adjustable, and you're just modulating and blocking the pain signals." (Medical Xpress)

Study Indicates External Vagus Nerve Stimulation May Hold Promise for Helping Treat Heart Failure

Aug. 20, 2014 - Researchers at the University of Leeds have published in Brain Stimulation that transcutaneous vagus nerve stimulation may have benefits for heart health through reducing sympathetic nerve activity. They studied externally applied stimulation to the auricular branch of the vagus nerve (distributed to the skin of the ear) in 48 healthy subjects, resulting in increased heart rate variability. They postulate that indication of increased parasympathetic activity may suggest a potential intervention for conditions such as heart failure. (University of Leeds)

Commentary Notes Advantages and Concerns About Occipital Nerve Stimulation for Medication-Resistant Migraine

Aug. 19, 2014 - Occipital nerve stimulation effectively relieves medication-resistant chronic migraine for more than one year, providing good or excellent headache relief, although a high rate of adverse events remains a concern, according to a research highlight about a randomized controlled trial with 157 subjects. (Nature Reviews Neurology)

Deep Brain Stimulation Patient Resumes Classical Music Career

Aug. 17, 2014 - A concert violinist received deep brain stimulation in 2009 for essential tremor at the Mayo Clinic in an operation that included his playing a violin during the procedure with a bow equipped with an accelerometer to check the effectiveness of target stimulation. He returned to play with the Minnesota Orchestra within weeks. (CNET)

Private Vagus Nerve Stimulation Firm Selects Investment Banking Company

Aug. 18, 2014 - Saying it is fully funded until 2016, electroCore reports increasing interest in its non-invasive vagus nerve stimulation therapy over the last six months from Medical device companies and pharmaceutical and technology companies as well. The New Jersey-based privately held company has appointed the investment banking firm Piper Jaffray to assist in partnering discussions with pharmaceutical companies regarding commercialization of the technology. (Market Watch)

Neurology Group Updates Guidelines for Vagus Nerve Stimulation in Epilepsy

Aug. 18, 2014 - The American Academy of Neurology has updated its evidence-based guideline concerning vagus nerve stimulation for the treatment of epilepsy, saying it "may be considered progressively effective in patients over multiple years of exposure," and improvement in mood may be an additional benefit in adults with epilepsy, while overall, it may be considered an adjunctive treatment for children with partial or generalized epilepsy. (Clinical Neurology News)

FDA Calls for Workshop on Brain-Computer Interfaces Aimed to Augment Movement of Patients

Aug. 18, 2014 - In November the FDA will hold a workshop on brain-computer interfaces to discuss scientific, clinical and regulatory considerations of neuroprostheses under development to aid movement of paralyzed patients or amputees. That discussion could influence draft guidance. (The Gray Sheet)

Mice Showed Gains in Post-Stroke Recovery With Optogenetic Stimulation

Aug. 18, 2014 - A Stanford University research team has shown that stimulating the motor cortex in mice using optogenetics allowed the animals to improve their recovery from stroke, even five days afterwards. The study was published in the Proceedings of the National Academy of Sciences. The authors hope to identify which brain circuits might be most amenable to post-stroke intervention in a potential future human clinical trial. (BBC News)

Canadian Firm Works on Sleep Apnea Medical Implant

Aug. 16, 2014 - Canadian-based Ergoresearch Ltd. announced a $590,000 royalty payment to its medical device subsidiary Victhom Laboratory Inc. represents "a strong validation" of a neurostimulation approach to obstructive sleep apnea completed by its partner Otto Bock Healthcare. The technology records and stimulations peripheral nerves, delivering therapy only when necessary. Further royalties may be forthcoming if the device is commercialized. (Sleep Review)

Article Describes Deep Brain Stimulation for Dystonia

Aug. 15, 2014 - An article about deep brain stimulation for dystonia says it has been a gold standard for relieving symptoms for some patients since becoming available about a decade ago. (WWSB)

Article Highlights Neurostimulation Appropriateness Consensus Committee Findings

Aug. 14, 2014 - International Neuromodulation Society President Simon Thomson, MD, was interviewed for a news feature about work of the Neuromodulation Appropriateness Consensus Committee that resulted in the first comprehensive peer-reviewed guidance for neurostimulation therapy, which appears in this month's issue of Neuromodulation: Technology at the Neural Interface. The article cites the effectiveness and cost efficiency of the therapy, pointing out that the co-authors are addressing "current gaps related to this treatment modality". (Medscape)

Burglars Take Chronic Pain Patients' Investigational Neurostimulation Controller

Aug. 14, 2014 - A woman who was participating in a clinical device trial has lost the patient controller that allowed her to switch between stimulation parameters for her spinal cord stimulator implant, when the remote control was stolen along with other electronics during a residential burglary. News reports said her controller was only one of three in her country. She said she has endured massive spasms of pain since the burglary two weeks ago, missing sleep and cutting back hours at work. (New Zealand Herald)

Visual Prosthesis Company Plans a Public Stock Offering

Aug. 13, 2014 - Second Sight Medical plans a $32 million public offering, on NASDAQ under the ticker symbol EYES, while it considers trying to expand the market the its Argus II visual prosthetic beyond the relatively few sufferers of retinitis pigmentosa to the wider group of people who have age-related macular degeneration. Meanwhile, it is at work on a next-generation device, the Orion I, that its leadership believes could address nearly all forms of blindness, and that could be developed two to three years after the stock offering. (Mass Device)

Neuromodulation: Technology at the Neural Interface Publishes the First Comprehensive Neurostimulation Guidelines

Aug. 12, 2014 - The  Neuromodulation Appropriateness Consensus Committee, comprised of 60 experts convened by the International Neuromodulation Society (INS), publishes the first comprehensive guidance on the use of neurostimulation for chronic pain and ischemic disease in the August 2014 issue of the official journal of the INS, Neuromodulation: Technology at the Neural Interface. (Newswise)

German Health System Will Cover Retinal Implant

Aug. 11, 2014 - Retina Implant AG announced the German health system will cover its implant to partially restore vision in late-stage retinitis pigmentosa, Alpha IMS. The microchip-based device is implanted behind the retina, to stimulate healthy nerve cells there. The device received CE mark approval in 2013 and this is its first reimbursement coverage announcement. (Mass Device)

Medicare Administrator in New England and the Midwest Will Reimburse Posterior Tibial Nerve Stimulation for Overactive Bladder

Aug. 11, 2014 - Uroplasty, Inc. announced a positive coverage decision for its device that delivers posterior tibial nerve stimulation to treat symptoms of overactive bladder. The decision from National Government Services, a Medicare administrative contractor, applies to approximately 10 million Medicare beneficiaries in the states of New York, Illinois, Massachusetts, Wisconsin, Minnesota, Connecticut, Maine, New Hampshire, Rhode Island and Vermont. The company said it will increase its marketing to those areas. (Wall Street Journal)

Neuromodulation Recipients Are Among Long-Distance Runners for Company Race

Aug. 11, 2014 - Three patients who have deep brain stimulation implants and another who has a spinal cord stimulator are among the 25 runners who have medical technology implants and will compete as a team sponsored by Medtronic, Inc. in the Twin Cities, MN in October. Running as "Medtronic Global Heroes" the international team will compete in the Medtronic Twin Cities Marathon or TC 10 Mile on Oct. 5, 2014. (3BL Media)

Medical Center to Offer Deep Brain Stimulation for Obsessive Compulsive Disorder

Aug. 11, 2014 - The University of Pittsburgh Medical Center will be offering deep brain stimulation to certain patients who have obsessive compulsive disorder through an FDA Humanitarian Device Exemption, which generally enables patients to seek insurance coverage for the procedure. (Post-Gazette.com)

Public Media Program Features Boston-Area Research Into Brain Stimulation and Decision-Making

Aug. 7, 2014 - The Boston public radio station features reporting about research into decision-making and brain stimulation. An application of the research may be to help veterans with traumatic brain injuries who have difficulty weighing cost-benefit decisions, according to one researcher interviewed who is studying stimulation to the dorsolateral prefrontal cortex. (WBUR)

Children's Hospital Adds Sacral Neuromodulation Capability

Aug. 8, 2014 - International Neuromodulation Society member Steven Teich, MD was interviewed about a new pediatric sacral neuromodulation implant service offered by the Surgical Neuromodulation Program at Nationwide Children's Hospital in Columbus, Ohio. The interview concerned the case of a 16-year-old Northern California girl who had had to use a permanent tube in her abdomen to flush her digestive system with a saline solution in an often-painful and time-consuming process. The news coverage says the device "addresses communication problems between the brain and the nerves that control bowel and bladder function." For an average patient, it may take 6-12 months to have the colon begin functioning more normally. (WFMZ-TV)

Neuromodulation Company Completes Its Acquisition of a Private Manufacturer of Pain Interventions

Aug. 7, 2014 - St. Jude Medical, Inc. announced it has completed its acquisition of privately held NeuroTherm, Inc., a manufacturer of interventional pain management therapies. The acquisition for approximately $200 million was announced initially in July. (Fierce Medical Devices)

Article Sees Bright Future for Electrical Implants

Aug. 7, 2014 - An article about the newly emerging field of electroceuticals mentions a recently approved neurostimulation device for obstructive sleep apnea (as well as other neuomodulation products under development) and predicts, "Within a decade or two, electrical implants could treat a wide range of common conditions." (Newsweek)

Add-on Payment for Medicare Coverage Approved for Closed-Loop Device for Epilepsy

Aug. 6, 2014 - NeuroPace, Inc. received approval from the Centers for Medicare & Medicaid Services for a New Technology Add-on Payment (NTAP) for its RNS® System, a responsive neurostimulation system that uses closed-loop feedback as an adjunctive control for some types of medically refractory epilepsy. The NTAP program is designed to support timely access to innovative technologies for Medicare beneficiaries. (Biospace)

Sinus-Cavity-Based Stimulation Device is Under Consideration as a Potential Approach to Treating Alzheimer's Disease

Aug. 5, 2014 - Wedge Therapeutics, a privately held medical device development company in St. Paul, Minn., acquired technology for minimally invasive brain stimulation using a sinus cavity device, a sphenoid and olfactory nerve stimulation system (SONS), in 2013. To explore its potential application in treatment for Alzheimer's disease, the company is currently seeking investment and industry partnerships. (Business Wire)

Article Explores the Future of Electrical Stimulation Technologies

Aug. 5, 2014 - Developing future "memory chips" builds on decoding how the brain works through neuroscience, according to a news feature, and possible applications might include cognitive enhancement, such as the potential for transcranial direct current stimulation to enhance an alert "flow state." The article says the advances might also aid in addressing some neurological deficits or disorders, such as in making neural prosthetics to assist with some types of vision or hearing loss, or therapies that might help improve some medication-resistant disorders. (Business Insider)

Intrathecal Baclofen's Role in Regulatory Circuits Investigated

August 2014 - International Neuormodulation Society members Damianos Sakas, MD, PhD, and Stylianos Gatzonis, MD, are among the co-authors of an article describing the impact of intrathecal baclofen (ITB) on a neuropeptide, orexin-A, that is implicated in regulation of processes that include arousal and reward. The orexin-A levels in the cerebrospinal fluid went down in nine individuals who received ITB for hypertonia, such as spasticity associated with dystonia. (Journal of Clinical Psychopharmacology)

Review Examines Deep Brain Stimulation in Obsessive Compulsive Disorder

August 2, 2014 - International Neuromodulation Society member Veerle Visser-Vandewalle, MD, PhD, contributed to a review article about deep brain stimulation (DBS) for obsessive compulsive disorder (OCD). The article reviews 25 studies involving 99 patients and five different DBS targets, noting 200 individuals have received DBS for medically refractory OCD since 1999. The authors conclude that for treatment-refractory OCD, DBS seems relatively safe and promising although no superior target was identified, and more research is needed to personalize treatment of severely affected individuals. (BioMed Central)

Report Describes a Possibly New Stimulation Target for Medically Refractory Headache

July-August 2014 - International Neuromodulation Society member Chandan Reddy, MD, has co-authored a case report of what may be the first published report of stimulation to the great auricular nerve to treat medically refractory post-traumatic headache. (Pain Physician)

Study Tracks Safety, Outcomes, from Stimulation of the Cervical Spine

August 2014 - A single-surgeon experience tracking complications and efficacy of spinal cord stimulation at the cervical level for chronic pain or the cervicomedullary junction for facial pain in 100 patients indicates that the interventions are safe and efficacious and may provide more pain relief in the upper limbs than axially, and in the head or face than in the occipital region. (Neurosurgery)

Researchers Identify Possible Biomarker for Parkinson's Disease Stimulation Target

July 30, 2014 - Microelectrode recordings may help optimize the location of deep brain stimulation for patients with Parkinson's disease, with the beta-band frequency peaks that are enhanced by the disease being recorded and weighed together to map neuroanatomical variability in patients in an off-medicine state, serving as a biomarker for the location of the subthalamic nucleus sensiorimotor neurons, according to a study of 20 patients over more than two years of follow-up. International Neuromodulation Society member Damianos Sakas, MD, PhD and co-authors validated this hypothesis by showing a statistically significant difference in maximum peaks in 9 patients who responded well to deep brain stimulation versus 11 who did not; saying that the putative biomarker could provide intra- and post-operative support in optimizing stimulation of the therapeutic target. (IEEE Journal of Biomedical and Health Informatics)

Neuromodulation is Called a Third Treatment Domain for Some Conditions

Spring 2014 - An article about non-invasive electrical stimulation for medically refractory depression or other conditions calls neuromodulation a "third domain" in addition to medicine and psychotherapy for treating difficult psychiatric conditions. (U Magazine)

Article Reviews Repetitive Transcranial Magnetic Stimulation Studies in Addiction

July 28, 2014 - In a review of 19 studies involving repetitive transcranial magnetic stimulation and addiction to tobacco, alcohol, cocaine or methamphetamine, a group of psychiatric researchers conclude that the currently experimental treatment appears to show promise. (Annals of the New York Academy of Sciences)

New Mode of Magnetic Stimulation Studied for Mood Disorders

July 28, 2014 - Low field magnetic stimulation appears to have an immediate effect on mood in study subjects with major depressive disorder or bipolar disorder, according to double-blinded research published in Biological Psychiatry involving 63 volunteers. The stimulation was administered with a portable, tabletop device designed by the study author. (Harvard Gazette)

Column Considers Challenges of Adding a Neuromodulation Device to a Psychiatric Practice

June 2014 - Adding a transcranial magnetic stimulation device to a psychiatric practice calls for skills not introduced during initial medical education, as well as ongoing device support and industry interaction, balancing business considerations with impartial assessment of clinical need, say guest columnists in an editorial in an issue of Psychiatric Annals focused on therapeutic neuromodulation. (Psychiatric Annals)

Clinical Trial of Neurostimulation in Chronic Low Back Pain Can Expand to Centers in the United Kingdom

July 28, 2014 - Mainstay Medical International plc has received regulatory permission to expand the clinical trial of its implantable neurostimulation device, ReActiv8, to include sites in the United Kingdom. The study is investigating the potential treatment for adults with debilitating chronic low back pain who have few other options. (Wall Street Journal)

Startup Seeks Partnerships to Develop Clinical Data

July 28, 2014 - Soft, thin, stretchable leads that can be more affordably manufactured are under development by the Milan- and Berlin-based start-up WISE Srl (Wiringless Implantable Stretchable Electronics), which, in preparation for seeking CE mark approval, is looking for new partnerships with neurosurgeons focused on spinal cord stimulation and neurophysiologists focused on cortical grids recording. (Daily Buzz)

Woman Seeks Insurance Coverage for Deep Brain Stimulation for Tremor Related to Multiple Sclerosis

July 24, 2014 - A multiple sclerosis patient who was referred to deep brain stimulation for her tremor plans to appeal the decision by her insurance company to not cover costs of the procedure on the basis of not being medically necessary. (WUSA-9)

Child Who Received Auditory Brainstem Implant Now Notices Sounds

July 23, 2014 - A 3-year-old boy born deaf who became the first of 10 pediatric patients in a clinical trial of auditory brainstem implant therapy is now responding to sounds, two months after his surgery. (The Globe and Mail)

Closed-Loop Neurostimulation Device Maker Participates in Memory Research

July 22, 2014 - The maker of the first, and only, FDA-approved closed-loop responsive neurostimulation system, NeuroPace, Inc., announced its partnership with research teams at the University of Pennsylvania and the University of California, Los Angeles that are working with epilepsy patients on the Restoring Active Memory Projects of the Defense Advanced Research Projects Agency. (Digital Journal)

External Trigeminal Nerve Stimulation to Be Studied as Adjunctive Therapy in One Type of Childhood Epilepsy

July 22, 2014 - The National Institutes of Health is supporting an open-label trial of external trigeminal nerve stimulation (eTNS) in children aged 8 to 18 as adjunctive therapy for the treatment of Lennox-Gastaut Syndrome, a challenging form of childhood epilepsy. The study at the Olive View-University of California, Los Angeles Medical Center in Sylmar, CA will involve nightly stimulation using an eTNS device from NeuroSigma, Inc. (Digital Journal)

Neuroprosthetics Researcher to Head Center in Switzerland

July 18, 2014 - International Neuromodulation Society member John Donoghue, PhD, a neuroscientist at Brown University who works on brain-computer interfaces, will direct the new Wyss Center for Bio- and Neuro-Engineering in Geneva. Funded with more than $100 million from a foundation started by Hansjörg Wyss, the center will have more than a dozen labs for research such as neuroengineering and regenerative engineering. (Science)

Parkinson's Patient in the UK Describes Benefits of His Deep Brain Stimulation

July 22, 2014 - In a profile of a Parkinson's disease patient who received deep brain stimulation 13 years after his diagnosis, his neurosurgeon said that relatively few Parkinson's disease patients in the United Kingdom are offered deep brain stimulation due to lack of awareness among sufferers and throughout the medical profession. Also, a representative of the charity Parkinson's UK said disagreements about who should pay may have an impact in some areas. (Express.co.uk)

Article Considers the State-of-the-Art in Neuromodulation Methods

July 15, 2014 - An overview of therapeutic neuromodulation describes current and emerging methods of stimulating or inhibiting neurons, and concludes that there is a trend toward multimodal neuromodulation. The authors say electrical neural stimulation "remains the gold standard" in clinical use but "the days of using just electrical stimulation on its own may be numbered." (Frontiers in Neuroengineering)

Early Tests Reported Concerning Steering Technology for Deep Brain Stimulation

July 2014 - International Neuromodulation Society (INS) member Claudio Pollo, MD and colleagues report intraoperative testing of directional deep brain stimulation compared to omnidirectional stimulation in 13 patients with either Parkinson's disease or essential tremor; the first testing of directional stimulation suggested by computed models in humans. They report the therapeutic window was wider in the best direction of stimulation, while the therapeutic current threshold was lower, and call for chronic implantation to further confirm the findings. INS member Alexander Green, FRCS(SN) and Prof. Tipu Aziz published a commentary about this steering technology. (Brain)

Non-invasive Optogenetics Research Advances in Animal Studies

July 17, 2014 - Researchers at MIT are developing a light-sensitive protein in optogenetics research that, in mice, has been shown to suppress neuronal activity non-invasively, with exposure to a light source outside the brain, to a depth of up to 3 millimeters. (AANS Neurosurgeon)

Non-invasive Stimulation Studied to Improve Reasoning, Learning and Memory

July 16, 2014 - The U.S. Intelligence Advanced Research Projects Activity is funding a a three-and-a-half-year, $12.7 million program, "Strengthening Human Adaptive Reasoning and Problem-Solving," SHARP, through a Boston-based contractor, Charles River Analytics. The University of New Mexico (UNM)  and Georgia Tech are partnering to use brain-building games in combination with meditation or mindfulness training and transcranial direct current stimulation to improve memory and problem-solving. Over the months of the training in the study, progress is tracked using fMRI. A researcher at the UNM Psychology Clinical Neuroscience Center said that as the approach is developed, it might become a less-expensive alternative to pharmaceuticals to address mental conditions and try to restore more effective brain function. (Medical Xpress)

Neurosurgeon Provides Deep Brain Stimulation Services in Canadian Province

July 16, 2014 - A story about a Saskatoon woman who received deep brain stimulation to manage her dystonia symptoms quotes her doctor, International Neuromodulation Society member Ivar Mendez, MD, PhD, who was recruited from Nova Scotia to serve as head neurosurgeon in the region. (Leader-Post)

Proponent Calls for Cooperation and Collaboration in Brain-Research Efforts

July 14, 2014 - "We need to support and fund every rational strategy that could make headway in our understanding of the brain," says U.S. Rep. Chaka Fattah in a column responding to an open letter by scientists critiquing the European Union's effort to simulate the brain, the Human Brain Project. (Huffington Post)

Company Announces Device Approval in China

July 14, 2014 - Advanced Bionics said its waterproof cochlear implant, which allows users to go swimming, the Neptune, has been approved for use in China. (Mass Device)

Sister of Deep Brain Stimulation Patient Nominated for Award for Her Fundraising

July 14, 2014 - A woman who raised $18,000 for Parkinson's disease research by running a marathon after her sister's diagnosis was nominated for a Pride of Australia medal. Her sister received a deep brain stimulation impact after rigidity and tremors forced her to stop her work as a television producer. (news.com.au)

Company Broadens Its Stake in the Chronic Pain Intervention Market

July 14, 2014 - Adding to its chronic pain management portfolio, St. Jude Medical, Inc. agreed to acquire radiofrequency device-maker NeuroTherm, Inc. for approximately $200 million. St. Jude Medical described the acquisition as strengthening its position in chronic pain therapies, by becoming the only medical device manufacturer to offer radio frequency ablation products as well as spinal cord stimulation systems. The transaction is being structured so that it is expected to be complete before the fourth quarter, with some $10 - 15 million in revenue from NeuroTherm adding to St. Jude Medical's 2014 sales. (Seeking Alpha)

$22.5 Million Brain-Mapping Project Will Investigate Boosting Memory

July 9, 2014 - As part of a Defense Advanced Research Projects Agency initiative on "Restoring Active Memory" scientists and physicians at the University of Pennsylvania will be seeking biomarkers of memory by mapping brain activity of neurosurgical patients with epilepsy or Parkinson’s disease who participate in carrying out memory games as part of the study. In the four-year, $22.5 million project, patients will be recruited at the Hospital of the University of Pennsylvania and six other centers: Thomas Jefferson University Hospital, Dartmouth-Hitchcock Medical Center, Emory University Hospital, the University of Washington Medical Center, the Mayo Clinic and the National Institutes of Health Clinical Center. (Penn News)

Segment Features "Brain Radio" Technology Study

July 8, 2014 - Calling it a "stunning innovation" that is just beginning, a regional television segment features work on recording-and-stimulating brain targets in Parkinson's disease patients, which is being carried out in neuroscience research at Stanford University. The device is referred to as a "brain radio" since it can transmit information about neural activity as well as receive stimulating pulses. (KTVU)

News Feature Surveys Brain Research Providing Insight Into the Functional Basis of Memory

July 9, 2014 - International Neuromodulation Society member Ashwini Sharan, MD, was quoted in a story about brain recording in epilepsy patients to try to identify seizure origin -- evaluations that can simultaneously provide information about neural circuitry and memory. (New York Times)

External Trigeminal Nerve Stimulation Studies Presented at European Epileptology Meeting

July 8, 2014 - NeuroSigma, Inc. recapped a number of presentations made last week at the 11th European Congress on Epileptology in Stockholm, Sweden about external trigeminal nerve stimulation, which the company plans to evaluate for drug-resistant epilepsy in a pivotal clinical trial. (PR Newswire)

Device Maker Files Information Submission with the FDA

July 7, 2014 - Mainstay Medical has submitted a Pre-Investigational Device Exemption Information package to the FDA concerning the company's neurostimulation device for low back pain, ReActiv8. The submission can allow requesting feedback on a proposed study design or statistical analysis plan for an Investigational Device Exemption prior to a clinical trial to establish device safety and efficacy. (Becker's Spine Review)

External Headache Devices Now Classified as Moderate Risk by the FDA

July 7, 2014 - The FDA has downgraded external headache treatment devices from a Class III to a Class II medical device, no longer requiring premarket approval, but instead a shorter (510)k review pathway. (Mass Device)

Researchers Rule Out Gastrointestinal Transit Rate to Explain Improvements from Sacral Neuromodulation

July 4, 2014 - Small-intestine transit patterns remained steady in patients with diarrhea-predominant or mixed irritable bowel syndrome after four weeks of sacral nerve stimulation (SNS) during a small crossover trial at Aarhus University Hospital in Denmark. The researchers note that SNS helps limit frequency, urge, and time on the toilet and reason those benefits may come from moderating colorectal sensory perception. (Healio)

Non-invasive Brain Stimulation Pilot Study Planned in Treatment-Resistant Anorexia

July 2014 - A Toronto-based center is starting a clinical trial of repetitive transcranial magnetic stimulation in treatment-resistant anorexia nervosa. The pilot study targets the insula, which plays a role in perception, mood, anxiety and feeding. (Centre for Addiction and Mental Health)

Epilepsy Brain-Stimulation Study Finds Switch for Consciousness

July 2, 2014 - Researchers at the University of Washington found that stimulating the claustrum when probing the brain of an epileptic woman for the origin of her seizures led to a temporary, reversible loss of consciousness. At the same time her frontal and parietal brain regions increased synchrony of electrical activity. While the results may not be fully generalizable since she had previously had part of her hypothalamus removed, the researchers believe lower-frequency stimulation of this area may help arrest an epileptic seizure or potentially help with recovery from minimally conscious state. (New Scientist)

NIH to Invest in Organ-System Peripheral Neurostimulation Development

July 3, 2014 - The NIH is expected to announce a $248-million, 6-year electroceuticals project, tentatively called Stimulating Peripheral Activity to Relieve Conditions (SPARC), to map nerves and electrical activity of five yet-to-be-decided organ systems -- a task compared to monitoring passing cars to predict which freeway exits they will take -- and then develop disease-treating, recording-and-stimulation electrode interfaces for them. (Nature News & Comment)

Vagus Nerve Stimulation Company's Funding Round is Oversubscribed

July 1, 2014 - A funding initiative started last April by electroCore, a New Jersey-based electroceutical company, has been oversubscribed by $10 million, bringing the total investment to $50 million upon agreement of all the parties, including Merck's Global Healthcare Innovation Fund. The company's non-invasive vagus nerve stimulation device is currently in four randomized studies focused on cluster and migraine headache. The gammaCore device is CE marked in Europe for primary headache, bronchoconstriction epilepsy, gastric motility disorders, depression and anxiety. (MarketWatch)

 

Low-Back Pain Clinical Trial Expands to Belgium

June 30, 2014 - The Belgium Federal Agency for Medicines and Health Products has granted Mainstay Medical International plc permission to expand its clinical trial there of the ReActiv8 implantable neurostimulation device for low back pain. The clinical trial started in Australia in March 2014. (Wall Street Journal)

Guidelines for Overactive Bladder Treatment List Percutaneous Tibial Nerve Stimulation Third

June 30, 2014 - Percutaneous tibial nerve stimulation (PTNS) is listed as a third-line therapy for overactive bladder in the recently updated guidelines from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Uroplasty, Inc. announced. The company is the only manufacturer of a commercially available PTNS system, Urgent® PC. (MarketWatch)

Comparison Study Finds Burst Stimulation More Effective on Average Than Conventional Stimulation

June 26, 2014 - Burst stimulation was preferable to tonic stimulation in 102 patients who received spinal cord stimulation at a center in Belgium or one in the Netherlands. The patients had been receiving conventional (tonic) spinal cord stimulation and were either responders or had stopped responding to tonic stimulation. Of the group that no longer responded to tonic stimulation, 62.5% responded to burst stimulation, with an average pain suppression of 43%. Most responders to tonic stimulation responded further with burst stimulation, with average pain suppression in that group increasing from 50.6% to 73.6%. (Clinical Journal of Pain)

Pilot-Study Results Presented on Vagus Nerve Stimulation for Chronic Migraine

June 26, 2014 - Two posters at the American Headache Society meeting in California showed that a sham-controlled pilot study of electroCore's non-invasive vagus nerve stimulation therapy for chronic migraine met its safety endpoint and demonstrated a reduction in headache days for patients using the active device. (Digital Journal)

Sacral Neuromodulation Gains Ground with Increased Funding in the Province of Ontario

June 24, 2014 - International Neuromodulation Society member Magdy Hassouna, MD, PhD is mentioned as one of two urologic surgeons in Ontario, Canada who provides sacral neuromodulation. An increase in funding from the Ministry of Health means 120 patients a year can now be treated for symptoms of overactive bladder and other urologic dysfunctions. (Toronto Star)

Early Results Reported on New Neurostimulation Lead for Pain Control in Amputees

June 2014 - In a proof-of-concept trial of a peripheral nerve stimulator intended to be less invasive and more flexible and stretchable for use in amputees, 14 of 16 patients experienced significant pain relief in a two-week trial, according to a presentation by International Neuromodulation Society member Richard Rauck, MD, at the 2013 annual Pain Medicine Meeting of the American Society for Regional Anesthesia and Pain Medicine. (Pain Medicine News)

Review Documents Non-Motor Improvements from Deep Brain Stimulation in Parkinson's Disease

June 26, 2014 - A review of the scientific literature by a physician in Britain documents the effects of deep brain stimulation in improving non-motor symptoms, such as sleep disturbances, in addition to motor symptoms in Parkinson's disease, said to be the second most common neurodegenerative disorder in the United States. (Medical News Today)

Low-Frequency Stimulation of White-Matter Brain Tracts to Be Investigated in Temporal Lobe Epilepsy

June 25, 2014 - A clinical trial starting at the George Washington University School of Medicine in patients with temporal lobe epilepsy will explore low-frequency stimulation of a white matter tract, that includes the fornix, to see if it reduces seizures without unduly impacting memory. In a previous study that used this stimulation mode temporarily in patients being monitored prior to surgery, low-frequency stimulation reduced seizures 92% while activating the hippocampus and other areas of the declarative memory circuit. That study was published in the Annals of Neurology in 2013 by Mohamad Z. Koubeissi MD and co-authors who are members of the International Neuromodulation Society: Emine Kahriman MD; Tanvir U. Syed MD, MPH; Jonathan Miller, MD; and Dominique M. Durand, PhD. (Newswise)

Retrospective Study Fine-Tunes Target for Deep Brain Stimulation in Dystonia

June 25, 2014 - A retrospective modeling study of 21 patients with DYT1-type dystonia who responded well to deep brain stimulation indicates the optimal stimulation target was a region of 135.5 cubic millimeters within the globus pallidus -- a "target within a target". (Medical Xpress)

Neurostimulation Company Joins Canadian Securities Exchange

June 24, 2014 - Intellectual property developed 20 years ago at the University of Wisconsin to deliver neurostimulation non-invasively under the tongue has been transferred to Helius Medical Technologies, which acquired NeuroHabitation Corporation and began trading on the Canadian Securities Exchange under the ticker symbol HSM. The new company is capitalized at $127 million. A Cooperative Research and Development Agreement with NeuroHabitation and the University of Wisconsin and the U.S. Army Medical Research and Materiel Command in 2013 focused on exploring the portable system for treating balance and gait issues from causes such as traumatic brain injury, multiple sclerosis and vestibular disorders. (Wall Street Journal)

Television Segment Features Overactive Bladder Treatment

June 24, 2014 - A woman who has received seven of her 12 weekly treatments for overactive bladder using posterior tibial nerve stimulation says she already has stopped having to get up in the middle of the night to use the restroom. The Terre Haute, Indiana clinic where she receives her treatment has just started offering this service. (MyWaboshValley.com)

Tinnitus Patients are Sought for Clinical Trial in Detroit

June 24, 2014 - The Henry Ford Health System in Detroit is recruiting patients with tinnitus for a clinical trial that compares sham treatment to vagus nerve stimulation paired with audio therapy. After six weeks, separate active and sham treatment groups will all receive active treatment. The center is one of four worldwide carrying out the study, funded by the U.S. National Institutes of Health. (Newswise)

Child Receives Deep Brain Stimulation to Control Her Dystonia

June 23, 2014 - International Neuromodulation Society member John Honeycutt, MD, was interviewed in a television segment about a 7-year-old girl in California who received deep brain stimulation for dystonia. Her procedure was done while she was asleep, and she has been showing improvements that should continue in the months to come. (ABC30)

UK Woman Awaits Word on Request for NHS to Provide Recommended Sacral Neuromodulation

June 19, 2014 - Due to what a local health authority termed  "gaps and inconsistencies," a Nottinghamshire, UK woman who has applied three times for a sacral neuromodulation implant to help her void her bladder over the last three years is still awaiting a response to her third request to the National Health Service. The 29-year-old woman was recommended for the operation by her consultant, who said it could "transform her life," which now involves catheterizing four or more times a day. (BBC News)

Technology Allows Paralyzed Patient to Move Hand

June 24, 2014 - International Neuromodulation Society Director-at-Large Ali Rezai, MD, director of the Ohio State University Neuroscience Program, was interviewed by major news media about the first paralyzed patient to undergo a clinical trial involving technology developed by Battelle research labs to restore motion to a paralyzed hand. The technology enabled the 23-year-old patient to use an implanted microchip sensor and a "sleeve" of electrode stimulators to open and close his hand for the first time since a spine injury from a diving accident four years ago. Dr. Rezai performed the neurosurgery to place the sensor on the patient's motor cortex. The patient is the first of five potential participants in the six-month trial. His participation was described in the Washington Post. (CBS This Morning)

Five-Year Study Shows Significant Benefit of Adjunctive Vagus Nerve Stimulation in Treatment-Resistant Depression

June 23, 2014 - A five-year study of nearly 800 people with treatment-resistant depression showed that in the 494 patients who also had vagus nerve stimulation (VNS) as an adjunct to usual treatment, VNS was safe and resulted in significantly better response and remission rates than usual treatment alone. The data show a 20- to 30-point separation in response and remission between the two groups, according to the observational study presented in Florida at the American Society for Clinical Psychopharmacology Annual Meeting. (Medscape)

News Show Features Deep Brain Stimulation Patient Who Has OCD

June 23, 2014 - A man with obsessive compulsive disorder is featured in a CNN segment about deep brain stimulation that likens his condition to a "neurological hiccup". The segment follows him through post-operative programming. (CNN)

Injured Former Firefighter Becomes an Advocate for Spinal Cord Stimulation

June 22, 2014 - International Neuromodulation Society President-Elect Dr. Timothy Deer explains when to consider spinal cord stimulation (SCS) as an option for chronic pain in a news feature about a former triathlete who eventually found relief for chronic pain through SCS after a sustaining injuries in an accident that required multiple surgeries. The former firefighter was able to return to work and stop taking pain medication. (Scoop San Diego)

In a Small Randomized Controlled Clinical Trial, Most Back-Pain Patients Preferred Burst Stimulation

June 19, 2014 - International Neuromodulation Society member Stefan Schu MD, PhD and colleagues report a randomized controlled clinical trial in 20 patients who use spinal cord stimulation (SCS) for failed back surgery syndrome. In random order, for one week, the patients received 500-Hz tonic stimulation, burst stimulation, and placebo stimulation. Sixteen patients (80%) preferred the burst stimulation mode, which overall provided better pain relief and quality of life in the short term of the research study. The authors recommend expanded studies in patients who have not previously received SCS. (Neuromodulation: Technology at the Neural Interface)

Sacral Neuromodulation Offered to Children at Pediatric Hospital

June 17, 2014 - Nationwide Children's Hospital in Ohio is piloting sacral neuromodulation in children for bladder and bowel control. A 16-year-old girl's case was described in which she had a permanent implant in May. For nine years, she had been unable to attend high school and underwent strictly timed, painful colon flushes that limited her ability to participate in activities. Her doctor said it may take 6 months to 1 year for the colon to begin functioning properly. The center has used the procedure on patients who have a missing or blocked passage for elimination of stool due to congenital imperforate anus. (News-medical.net)

Repetitive Transcranial Magnetic Stimulation Study in Post-Stroke Pain Indicates Possible Brain Networks Involved

June 17, 2014 - In 14 patients with central post-stroke pain and deficits in thermal perception, five sessions of repetitive transcranial magnetic stimulation targeted to the motor region for the affected area provided moderate pain relief for up to four weeks post-treatment. The analgesia correlated with improvements in detection of warmth, indicating the treatment mechanism may share circuitry for the processing of noxious and thermal signals, such as the insula and the somatosensory and anterior cingulate cortices. (Neuromodulation: Technology at the Neural Interface)

Health Charity Brings Parkinson's Study of Deep Brain Stimulation to Parliament

June 16, 2014 - Saying "there's still a postcode lottery in the UK when it comes to accessing Parkinson's services," the health charity Parkinson's UK presented a study it funded with the Medical Research Council and the Department for Health on deep brain stimulation to the All Party Parliamentary Group on Medical Research's summer reception. (Parkinson's UK)

Survey Identifies Factors That Influence Conversion to Spinal Cord Stimulation Implants

June 13, 2014 - A national survey of rates of conversion to permanent spinal cord stimulator (SCS) implants after a percutaneous trial found that relatively younger patients, those who had commercial insurance, and patients who had not previously attempted a percutaneous SCS trial were more likely to convert to a permanent implant. Of more than 20,000 percutaneous trials from 2000-2009 surveyed in the U.S., the overall conversion rate was 41.4%, with the highest rate (44.5%) in the North-Central region and the lowest (36.1%) in the Northeast. (Neuromodulation: Technology at the Neural Interface)

Pilot Study Data Reported Regarding Spinal Cord Stimulation for Heart Failure

June 13, 2014 - The era of device therapy to modulate autonomic tone has arrived, and randomized controlled trials should help to discern the extent of the promise, according to a commentary on a report from the Heart Rhythm Society Annual Scientific Sessions regarding 17 heart failure patients who participated in a clinical trial of spinal cord stimulation (SCS). With a mean followup of 18 months, the results of the first-in-man trial of dual-targeted high-thoracic SCS for systolic heart failure demonstrated safety and improved symptoms, functional status, left ventricular function and remodeling. (Healio)

Flexible, Wireless, Sensing-and-Stimulating Electrodes to Be Prototyped in Research Collaboration

June 11, 2014 - Lawrence Livermore National Laboratory (LLNL) has received $5.6 million from the Defense Advanced Projects Research Agency as part of the agency's Systems-Based Neurotechnology Emerging Therapies (SUBNETS) program. The laboratory previously contributed to development of Second Sight Medical Products's artificial retina, and in the SUBNETS program will work with Medtronic and collaborate with the University of California, San Francisco; UC Berkeley; Cornell University' New York University; PositScience Inc. and Cortera Neurotechnologies. LLNL plans to use thin-film technology and 3D packaging to develop flexible neural interfaces with hundreds of electrodes that operate wirelessly. (Phys.org)

Friends of Trigeminal Neuralgia Patient Seek Funds for Neurostimulation Implant

June 11, 2014 - A woman who seeks an off-label neurostimulation implant to control her chronic face and head pain is the subject of a fund-raising drive to try to raise $72,000 for the procedure. She has had trigeminal neuralgia with attacks almost weekly for five years, possibly related to sinus infections and repeat surgeries. (Missoulian)

Michigan Epilepsy Patients Receive Responsive Neurostimulation Implants

June 11, 2014 - The Grand Rapids, MI-based Spectrum Health Butterworth Hospital is one of 10 U.S. centers approved to implant the new NeuroPace Responsive Neurostimulation System. The first two Michigan patients received implants there in May to control symptoms of their epilepsy. (Medical Xpress)

Cluster Headache Therapy Results Released

June 10, 2014 - In the 10-center PREVA clinical trial in Europe, after three to four weeks of non-invasive vagus nerve stimulation therapy, 45 patients with cluster headache saw their number of incidents decrease by 46.3%. Another 48 patients who were randomized to receive the best available standard of care had a decrease of 12.5%. The stimulation was delivered using the gammaCore device by New Jersey-based electroCore Medical, LLC. (News-Medical.Net)

Florida Television Station Interviews Patient Who Prefers Neurostimulation to Ongoing Painkiller Use

June 10, 2014 - International Neuromodulation Society member Louis Raso, MD, describes the advantages of a newer spinal cord stimulator system that captures back pain without paresthesia to the legs, in an interview that also features a chronic-pain patient who says he benefited from the device. (WPLG)

Study: Adjusting Pulse Width Can Limit Side Effects of Deep Brain Stimulation

June 10, 2014 - Shorter pulse widths may avoid deep-brain-stimulation-related side effects for Parkinson's disease patients, according to a 15-person clinical study in Europe that was announced at the 18th International Congress of Parkinson's Disease and Movement Disorders in Stockholm. The Boston Scientific Corporation CUSTOM-DBS study in used its Vercise DBS System, which is undergoing a U.S. clinical trial, INTREPID, for the treatment of Parkinson's disease. (MarketWatch

Developer of Transcranial Magnetic Stimulation Therapy Raises Capital
June 9, 2014 - The medical device-maker Cervel Neurotech of Redwood City, CA has raised $11.1 million and is near the close of a $11.9 million round of financing, through the sale of equity, rights, and securities. The company is developing repetitive transcranial magnetic stimulation for neurological and psychiatric disorders, in an approach that involves multiple magnetic coils to steer the magnetic field to targeted regions of the brain. (Mass Device)

Pennsylvania Women's Health Center to Offer Sacral Neuromodulation

June 9, 2014 - Following training in Washington, D.C., Virginia, Lebannon and London, an obstetrics and gynecology practitioner who joined the Women’s Health Center at Cole Memorial Hospital in Coudersport, PA offers sacral nerve stimulation for some cases of treatment-resistant urinary or fecal incontinence. (The Bradford Era)

More Spinal Cord Stimulator Patients Could be Accommodated by Newcastle-Area Clinic

June 6, 2014 - The pain management team at the Royal Victoria Infirmary of the Newcastle Hospitals NHS Foundation Trust treats some 600 patients with chronic pain who use spinal cord stimulators, but has room for at least 100 more to be referred by their general practitioner, according to a nurse consultant at the Northeast England facility. (BBC)

Magazine Publishes Experts' Roundtable Discussion of Spinal Cord Stimulation

June 2014 - Pain Medicine News has published roundtable discussion about spinal cord stimulation patient selection, imaging considerations, and advances, which was held by specialists in anesthesiology, neurosurgery, pain medicine and radiology, and moderated by the magazine at the December 2013 annual meeting of the North American Neuromodulation Society. (Pain Medicine News)

Station Features Tinnitus Patient Who Hopes to Join a U.S. Clinical Trial Involving Vagus Nerve Stimulation

June 4, 2014 - A church choir director hopes to participate in a U.S. clinical trial that combines sound therapy with vagus nerve stimulation, having already found some relief in sound therapy alone. (KFSN)

Researchers in Germany Report an Investigative Brain Stimulation Target for Severe, Refractory Tourette Syndrome

June 2, 2014 - International Neuromodulation Society member Veerle Visser-Vandewalle, MD, PhD and co-authors at the University of Cologne Department of Psychiatry and Psychotherapy report a case series of eight patients with medically intractable, severe Tourette syndrome who were treated with deep brain stimulation in the ventral anterior and ventrolateral motor part of the thalamus to improve motor and emotional stability. Follow-up of up to one year indicated these duel stimulation targets may be a valuable option with a low side-effect profile. (Biological Psychiatry)

Trade Association Will Establish an Office in Shanghai

June 3, 2014 - The medical technology trade association AdvaMed plans to open a China office where it will work on efforts to streamline China's medtech regulation, boost reimbursement and harmonize ethical standards with those in place elsewhere. AdvaMed also established a council of China representatives from several member companies. The association received official approval to open this new office in Shanghai. (Mass Device)

Clinicians Demonstrate Benefits of Directional Deep Brain Stimulation

May 30, 2014 - In the first demonstration in humans, neurologists and neurosurgeons in Switzerland and Canada report in the journal Brain that 13 deep brain stimulation patients were involved in an intraoperative double-blind pilot study that showed that when using a smaller, directional electrode for stimulation, 43% less current was required for beneficial stimulation than with omnidirectional stimulation, and the therapeutic window to achieve the stimulation target was 41% wider, although computational modeling indicated the volume of tissue activated was only 4.2 cubic mm in the directional mode, as opposed to 10.5 cubic mm in the omnidirectional mode. (Medical News Today)

Preclinical Study to Enhance Deep Brain Stimulation Identifies Neuronal Role in Stress Response

May 28, 2014 - A study of synaptic modifications in mice, published in the Journal of Neuroscience, might help to refine deep brain stimulation for depression, according to researchers at Cold Spring Harbor Laboratory. They found that neurons in the medial prefrontal cortex were more excitable in depressed mice, but harder to excite in mice that exhibited resilience to environmental stressors, and plan to look more closely into excitatory or inhibitory factors. (Scientific American)

DARPA Project Researchers Target Higher-Resolution Recordings of Brain Circuit Activity

May 27, 2014 - The University of California, San Francisco and Massachusetts General Hospital are leading the five-year, $70 million program of the Defense Projects Research Agency to help military personnel with psychiatric disorders through implantation of brain-stimulation devices. Researchers in San Francisco will first attempt to obtain higher-resolution recordings of changes in real time from brain circuits of volunteers who have received implants for Parkinson's disease or epilepsy, many of whom also have depression or anxiety, according to a radio interview on All Things Considered. (NPR)

Future Closed-Loop Brain Stimulation Systems Will Need Low-Power Embedded Microprocessors

May 27, 2014 - An electrical and computer engineering professor who heads Rice University's Realtime Neural Engineering Laboratory and is an assistant professor of neurology at Baylor College of Medicine is working on developing deep brain stimulation that uses real-time computer processing to monitor and respond to changes in the brain. He says energy demands from this more precise approach, which should limit unwanted stimulation beyond the target, is one challenge in realizing the advance. (Medical Xpress)

Pioneer in Using Functional Electrical Stimulation Holds Question-and-Answer Session

May 27, 2014 - Jennifer French, executive director of the Neurotech Network, participated over the weekend in a Reddit "Ask Me Anything" session about her use of a functional electrical stimulation system to stand and transfer after incurring a partial spinal cord injury during a 1998 snowboarding accident. (Medical Device and Diagnostic Industry)

Deep Brain Stimulation Viewed As Best of Options by Former Wales Rock Musician

May 27, 2014 - A 64-year-old former rock drummer from Wales, Pete Boot, describes how deep brain stimulation earlier this year has restored much of his mobility and should help slow the impact of the Parkinson's disease he has coped with for the past 20 years. (contactmusic.com)

Researchers Look to Light-Converting Nanoparticle to Devise Optogenetics Without Fiber Optics

May 23, 2014 - Researchers at the University of Massachusetts Medical School have received a three-year. $900,000 grant from the Human Frontiers Science Program for preclinical studies of "wireless" optogenetics in mice and fruit flies. The researchers will use a new nanoparticle that can convert infrared light to blue light, in lieu of needing fiber optics to deliver a light pulse. (R&D Magazine)

Engineers Publish A Way to Power Microstimulators Wirelessly

May 23, 2014 - A Stanford University electrical engineering team has published in the Proceedings of the National Academy of Sciences their results showing that a 2mm-long microstimulator deep within tissue can be powered at what is deemed to be safe exposure levels by using a flat, patterned external charger that causes radio waves to propagate in a focused fashion through tissue. The method was demonstrated in a miniaturized cardiac pacemaker in a rabbit. (R&D Magazine)

Data Analysis: Spinal Cord Stimulation is Superior but Underused for Chronic Pain of Failed Back Surgery Syndrome

May 20, 2014 - An analysis of 16,455 patients with failed back surgery syndrome (FBSS) from 2000 - 2009 showed that in the 395 who received spinal cord stimulation (SCS), they experienced lower complication rates at 90 days than the patients who underwent lumbar reoperation, and the overall cost at two years was lower. International Neuromodulation Society member Shivanand Lad, MD, PhD and co-authors conclude that although previous studies have demonstrated its superior efficacy for FBSS, SCS remains underused and warrants closer consideration for the management of chronic pain in patients with FBSS. (Spine)

Occipital Nerve Stimulation Study Presented at Physician Assistants' Annual Meeting

May 26, 2014 - A poster presented at the American Association of Physician Assistants meeting in Boston described a reduction in the severity and frequency of chronic recurring headaches in a small study of patients receiving occipital nerve stimulation in Indiana. The 17 patients had shown an improvement in symptoms through an occipital nerve block prior to stimulator implantation. The severity of headaches declined in six months from an average of 9 on a 10-point scale to 3.3. (Clinical Advisor)

Portable Transcranial Magnetic Stimulation Device Receives Food and Drug Administration Approval

May 23, 2014 - Maryland-based eNeura announced it received FDA approval for its handheld SpringTMS system to relieve pain from migraines preceded by an aura. When users feel a migraine coming on, the mobile magnetic stimulator is held to the back of the head to temporarily depolarize nerve cells in the occipital lobe. Use of the device led to 38% of patients being pain-free within 2 hours of using the device, compared with only 17% of patients in the control group, in double-blind, placebo-controlled studies of more than 200 patients. (Mass Device)

Stroke Rehabilitation Study Using Magnetic Brain Stimulation Expands to More U.S. Centers

May 22, 2014 - Use of externally applied magnetic brain stimulation during occupational therapy for stroke rehabilitation helped 80% of patients regain use of their arm and hand, which was 30% more than possible with standard therapy, according to a pilot study of 30 patients at the Rehabilitation Institute of Chicago. The study, which directs the brain stimulation using navigated GPS-like tracking created by Nexstim Corporation, has been expanded after its initial six months to include 12 more centers in the U.S. (PR Newswire)

Journal Article Analyzes Media Coverage of Transcranial Direct Current Stimulation

May 22, 2014 - Only 8 out of 218 popular news articles about transcranial direct current stimulation mention its possible adverse effects, or advised caution, according to an analysis by researchers at the Institut de Recherches Cliniques de Montreal, which was published in Neuron. The authors make recommendations for a more balanced public discussion and view of the non-invasive stimulation, which has been presented in some news accounts as a potentially affordable, and even homemade, approach to cognitive enhancement. (Medical Xpress)

Interview Focuses on the Head of a Firm That Developed Non-invasive Vagus Nerve Stimulation

May 24, 2014 - ElectroCore Medical's CEO, J.P. Errico, discussed the company's external, non-invasive vagus nerve stimulation system and evolution from an acute, self-administered therapy for bronchoconstriction during an asthma attack to other uses, such as cluster headache, migraine, and potentially also pain, sleep disorders, and depression and anxiety. (Medgadget)

U.S. Patent Issued for Nerve-Blocking Technology

May 22, 2014 - Neuros Medical, Inc. announced it received a new U.S. patent for application of high-frequency electrical nerve block technology in nerves from 3mm - 12mm wide, with broad claims for treating pain, spasticity, and bladder dysfunction. Neuros now has three issued patents in its portfolio, with others pending. (Business Wire)

Experts Note Significance of Data on Spinal Cord Stimulation Wait Times

May 21, 2014 - Appropriate patient selection and referral to evaluation for spine surgery or pain medicine specialists should help to shorten wait times for spinal cord stimulation (SCS) and improve its chance of success, experts commented in an article about a poster at the American Academy of Pain Medicine 2014 annual meeting by Drs. Syed Rizvi and Krisha Kumar of the University of Saskatchewan. The poster about SCS wait times examined 437 patients and reviewed data from 443 patients. International Neuromodulation Society member Tim Deer, MD commented, "This information should encourage insurance companies to seek out centers of excellence and try to obtain access to SCS early in the severe nerve pain patient." (Pain Medicine News)

U.S. Woman Recounts Her Positive Experience with Neurostimulation for Treatment-Resistant Migraine

May 20, 2014 - International Neuromodulation Society member William Rosenberg and his patient were interviewed about neurostimulation therapy in a segment on Kansas City television. The piece reported that after a long search for an effective chronic migraine therapy, his patient received relief through occipital/peripheral nerve stimulation, which was covered by her insurance despite being off-label in the U.S. (WDAF-TV)

Physician in India Describes Parkinson's Disease Patient's Benefits From Deep Brain Stimulation

May 20, 2014 - A U.S.-trained physician in India describes how his young-onset Parkinson's disease patient was able to better manage symptoms after deep brain stimulation. (Times of India)

Neurostimulation Technologies Are Described as Showing "the Future is Now"

May 20, 2014 - Cyberonics Inc.'s AspireSR vagus nerve stimulation (VNS) system for epilepsy and Cirtec Medical Systems LLC's shrinking active-implantable devices are among the technologies presented in a column about futuristic advances that are already in implementation. The seventh-generation, wirelessly programmable VNS system with seizure response has CE mark approval and may be presented to the FDA with data from a recently completed clinical study. Meanwhile, Cirtec specializes in compact, hermetically sealed components and has provided contract services for neurostimulators targeting the brain, spinal cord, and vision restoration. (Medical Design)

Neurostimulation System for Treatment-Resistant Depression Receives Marketing Approval in Europe

May 20, 2014 - BioControl Medical of Israel announced CE mark approval in Europe for its FitNeS™ vagus nerve stimulation system for adjunctive use in treatment-resistant depression. The system applies low-amplitude stimulation to the vagus nerve to preferentially activate nerve fibers leading to the brain. (Business Wire)

Telemedicine Application Helps Brain Surgery for Movement Disorder

May 20, 2014 - A neurosurgeon conducting brain surgery on a young woman with severe, medically-resistant movement disorder was able to have real-time expertise from a Pennsylvania-based intraoperative neurophysiologist to track microelectrode recordings. Such web-based brain mapping was developed in part at the Greenville Neuromodulation Center of Pennsylvania. (University Chronicle)

Infant Said to Be Youngest to Receive Auditory Brainstem Implant in U.S. Clinical Trial

May 19, 2014 - A girl slightly less than 1 year old received an auditory brainstem implant in March as part of a clinical trial in the U.S. to investigate using the technology in young children who are not candidates for cochlear implants and never had the ability to hear. In the U.S. the implants are approved for patients aged 12 and older who have lost function of their auditory nerve due to cancer or an injury. The patient in Boston became the youngest to receive the implant as part of the clinical trial. (WBZ-TV)

Essential Tremor Patient Spreads Awareness About Deep Brain Stimulation

May 17, 2014 - A woman who benefited from deep brain stimulation for her essential tremor now gives talks to second-year medical students at Dartmouth College and to patient-support groups. The therapy allowed her to return to her occupation in hospital nursing. (Union Leader)

Neural Prosthetic System Under Development to Aid Movement After Partial Spinal Cord Injury

May 16, 2014 - The NEUWalk project in Europe has received some 9 million euros for research into an implanted microelectrode array that stimulates nerve roots in the spine to aid locomotion. The neural prosthetic system incorporates sensing microelectrodes and microprocessing. Two patients who have partial spinal cord injury are due to receive a tailored version of the device in the summer prior to a potential larger clinical trial. The preclinical version of the technology will be shown at the Sensor + Test measurement fair in Nürnberg, Germany June 3 - 5. The researchers believe such a system may have an application in Parkinson's disease as well. (News-Medical.net)

Voiding Dysfunction Company Reports Quarterly and Fiscal 2014 Results

May 15, 2014 - Uroplasty, Inc. reported increased revenues for the fourth quarter ending March 31, as well as the full fiscal year. The Minnesota-based company said sales of its Urgent® PC Neuromodulation System for voiding dysfunction were up 27% in the fourth quarter in the U.S. and 74% globally. An expansion of the marketing team led to operating expenses that contributed to a loss of $1.1 million in the fourth quarter of 2014, compared to $1 million in the fourth quarter of 2013, on total revenue of $24.6 million for the full year. (Market Watch)

Technology Publication Features Vagus Nerve Stimulation for High Blood Pressure

May 14, 2014 - Saying it may not be until 10 years that an implantable vagus nerve stimulator system for high blood pressure that was demonstrated in preclinical work is ready, an article in Medgadget points out that the approach is inviting since a renal denervation trial of Medtronic's Symplicity system failed to meet a primary efficiency endpoint in its clinical trial. (Medgadget)

Retinal Implant Company Plans an Initial Public Offering in Paris

May 13, 2014 - Pixium Vision of Paris is planning an initial public offering on Euronext Paris, a development covered in the French media, including L'Express. The company is targeting a 2015 market launch and is seeking CE mark approval for its retinal implant system, IRIS. (BioCentury)

Data Presented Comparing Medical Treatment for Depression With Transcranial Magnetic Stimulation

May 13, 2014 - A study of 306 patients with major depressive disorder showed that treatment with transcranial magnetic stimulation led to 53% reporting no or mild depression, compared to 38% of people on antidepressants reporting similar outcomes after the same length of treatment, according to a presentation at the 167th American Psychiatric Association Annual Meeting. (Time)

Brain Stimulation Study Links Oscillation Frequency With Conscious Awareness

May 11, 2014 - A sleep study with 27 healthy volunteers in Frankfurt, Germany, used transcranial alternating current stimulation (tDACS) during periods of rapid eye movement to induce self-awareness through a lucid dream state that is considered closer to consciousness, in which without awakening, subjects could control the course of their dreams. The authors of the paper in Nature Neuroscience say this is the first time that stimulation (applied between the frontal and temporal regions of the brain at lower gamma frequencies of 25 and 40 Hz) linked, in a causal fashion, synchronous oscillations at that bandwidth to conscious awareness. They believe frontotemporal tACS might help restore dysfunctional brain networks involved in schizophrenia and obsessive compulsive disorder, or help patients overcome post-traumatic nightmares. (Medical Xpress)

Burst-Mode Spinal Cord Stimulation Presented at Singapore Meeting

May 9, 2014 - Burst stimulation in spinal cord stimulation was described as influencing the medial pathway and thus helping take away the salience of pain, during a presentation at the Australian and New Zealand College of Anaesthetists annual scientific meeting in Singapore by one of the developers of St. Jude Medical's Prodigy device, which was approved for sale in Europe in April. At the same meeting,  the immediate past dean of the Australian and New Zealand College of Anaesthetists' Faculty of Pain Medicine said he is trying to set up a registry for neurostimulation devices. (The Age)

Selective Stimulation of Barofibers Described in Preclinical Study of Vagus Nerve Stimulation for Lowering Blood Pressure

May 8, 2014 - Scientists writing in the Journal of Neural Engineering describe proof-of-concept data from five rats for a vagus nerve stimulation cuff device, with 24 electrodes, designed to address hypertension. The prototype device includes detection and signal processing to sense barofibers and selectively stimulate them to lower blood pressure while avoiding unintentional stimulation effects such as bradycardia and bradypnea. The rats' blood pressure was adjusted to 60% and the effect lasted up to five times longer than the stimulation. (Medical Xpress)

Six-Month Followup Data Presented for Spinal Cord Stimulation Programming Software

May 8, 2014 - In 140 patients who have used the Boston Scientific Corporation Precision Spectra(TM) Spinal Cord Stimulator System for six months to control low back pain, data show significant and sustained pain relief, according to results presented at the World Institute of Pain 7th World Congress in Maastricht, The Netherlands. The system includes 3D software to guide programming of stimulation, and the clinician programmer using this software has now been launched for sale in Europe. Patients with low back pain reduced their 10-point-scale pain scores from an average 7.15 to 2. 93, while those with severe low-back pain reduced their average score from an initial baseline of 8.78 to 3.68. (Wall Street Journal)

Auditory Brainstem Implant Procedure Performed on First Pediatric Enrollee in Los Angeles

May 7, 2014 - The first preschooler has received an auditory brainstem implant in a clinical trial of up to 10 young children who do not have intact functioning cochlear nerves and so would not respond to a cochlear implant. The 3-year-old boy from Montreal was operated on in Los Angeles. After confirming his brain was responding to stimulation of the cochlear nucleus on the brainstem, his physicians plan to turn the implant on in June. The procedure has been used on people who lost hearing due to a tumor or accident, and in non-hearing patients, would be expected to help the auditory system function if it is performed while the brain is still completing its development during early childhood. (Los Angeles Times)

Pilot Study of Deep Brain Stimulation in Alzheimer's Disease Shows Progress

May 6, 2014 - A team of researchers centered in Cologne, Germany report in Molecular Psychiatry that after 11 months, four of six patients in a pilot study of mild-to-moderate Alzheimer's disease responded to bilateral deep brain stimulation to the nucleus basalis of Meynert. The Alzheimer's symptoms in these four patients remained stable or improved. The target in the medial forebrain was selected to stimulate release of acetylcholine since Alzheimer's disease is associated with loss of cholinergic neurons in this area that projects to the limbic system, which plays a role in the processing of memories. (WebMD)

Article Explores Popular Interest in Transcranial Direct Current Stimulation

May 5, 2014 - Transcranial direct current stimulation is catching the interest of hobbyists interested in pursuing cognitive gains, according to a news feature in Wired magazine. (Wired)

Implant to Treat Obstructive Sleep Apnea is Approved for Sale in the U.S.

May 5, 2014 - Inspire Medical Systems, Inc. has received FDA approval for its hypoglossal nerve stimulation system to treat a subset of patients who are unable to use continuous positive airway pressure for obstructive sleep apnea. The company was spun out of Medtronic, Inc. in 2007 and projects a U.S. market of about 400,000. Sales are expected to begin in mid-20014. (Today's Medical Developments)

China's Medical Device Market Continues to Expand

May 3, 2014 - A news feature describes how the medical device market in China is growing despite fears of intellectual property piracy. The country has shown double-digit growth in this sector, although its current market is just one-tenth the size of that in the U.S. As an example of the changes, Medtronic, Inc. began doing business in China in 1970 and opened an Innovation Center in Shanghai in 2012. Medtronic’s China revenues have grown from $50 million a decade ago to $800 million today. (Star Tribune)

Study: Shorter Longevity for Implantable Pulse Generators Used in Deep Brain Stimulation in Dystonia

May 2014 - Researchers at the University of Alabama at Birmingham have evaluated 470 consecutive Soletra implantable pulse generators and found that dystonia patients receiving pallidal deep brain stimulation needed more frequent stimulator adjustments and had a shorter longevity of their implantable pulse generator, compared to patients who received suthalamic and thalamic deep brain stimulation for Parkinson's disease or essential tremor. (Brain Stimulation)

Enrollment Complete in Clinical Trial of Deep Brain Stimulation in Alzheimer's Disease

May 1, 2014 - Toronto-based Functional Neuromodulation announced it has completed enrollment of 42 patients in a study of deep brain stimulation in mild Alzheimer's disease. The double-blind randomized controlled clinical trial, the ADvance Study, compares stimulation to the fornix with a control group of patients who receive no stimulation for 12 months, after which time the control group patients will also have their stimulators turned on. (NeuroNews)

Dystonia Patient Documents His Treatment Journey to Deep Brain Stimulation

May 1, 2014 - A dystonia patient who received deep brain stimulation to control his symptoms has produced a short film that was submitted to a competition at the American Academy of Neurology annual meeting in Philadelphia. (YouTube)

Study Shows Dopamine Drops When Stimulation is Halted in Obsessive Compulsive Disorder

April 30, 2014 - Fifteen patients who had stable obsessive compulsive disorder one year after receiving deep brain stimulation were studied with molecular brain imaging in a study in Biological Psychiatry. The imaging tracked fluctuations in the release of dopamine, which decreased after stimulation was turned off. The results suggest that enhancing striatal dopamine signaling may help relieve treatment-resistant symptoms of the disorder. (Medical Xpress)

Man Who Uses Newly Approved Visual Prosthesis Describes Its Benefits

April 30, 2014 - A man who was one of the first commercial users of Second Sight Medical's Argus II "bionic eye" visual prosthesis described how helpful it is to be able to counteract the impairment of his retinitis pigmentosa by now being able to distinguish between light and dark shapes and see contrasts. That change allows him to navigate his world much better, he said. (Mass Device)

Company Developing Back-Pain Implant Raises €18 million

April 30, 2014 - Mainstay Medical raised €18 million in an initial public offering that is said to be the first by a medical technology company to be simultaneously held in Dublin and Paris. The company makes a novel implanted device designed to stimulate muscles that stabilize the lower back, in order to treat chronic back pain. (Irish Times)

Entrepreneurs Plan a Noninvasive Approach to Cognitive Enhancement

April 30, 2014 - Halo Neuroscience plans to use a range of electromagnetic approaches, including electricity, magnetic fields, infrared light, and radio waves, for its external devices to improve cognition. The company was started by Amol Sarva, PhD and includes former NeuroPace Inc. employees Daniel Chao, MD and Brett Wingeler, PhD. The company received a $1.5 million financing round backed by venture capital investor Marc Andreessen. (The Verge)

News Coverage Presents Spinal Cord Stimulation as an Option in Chronic Back Pain

April 30, 2014 - A special report on using spinal cord stimulation for back pain says it has been around since the 1960s but it has taken off in recent years, is covered by medical insurance, and can be an option a physician might consider in cases of chronic pain. A patient who did not receive relief from repeat back surgery is profiled. (Kiii News)

Community Turns Out to Help a Patient Who Plans to Travel to Receive Deep Brain Stimulation

April 29, 2014 - Friends organized a community event to help raise money for a Parkinson's disease patient who plans to have deep brain stimulation surgery out of town, in Kansas City. For a nominal fee, 300 people donned glow-in-the-dark attire to participate in the event, which included a 1.6-mile race followed by a dance and obstacle course. (Hays Daily News)

Authors Propose Ways to Foster Research into Neurological Devices

April 22, 2014 - International Neuromodulation Society member Andre Machado, MD, PhD, and co-authors write in Neurology that "both the structure of clinical trial funding and the current regulation of device research" dissuade "formal and prospective research with novel devices or novel indications". They suggest five remedies, including combining federal grant awards with regulatory approval and providing private insurance for clinical trials. (Neurology)

Neuromodulation Sales Contribute to Company's Quarterly Earnings

April 29, 2014 - Boston Scientific Corporation reported a higher adjusted profit in the first quarter of 2014 that ended March 31, partly due to higher sales of neuromodulation and heart rhythm management devices. Net earnings for the quarter were $133 million, or 10 cents a share. (Reuters)

Neuromodulation Company Appoints Chief Commercialization Officer

April 28, 2014 - Autonomic Technologies, Inc. (ATI) has appointed Karl Schweitzer chief commercialization officer. Previously, as a vice president at Medtronic, Inc. he served on the global leadership team for Medtronic's neuromodulation business. At ATI, he will lead global sales and marketing. The company received CE marking in Europe for its treatment for cluster headache, the ATI™ Neurostimulation System. The system is now being investigated in a multi-center, randomized study for the treatment of high frequency, high disability migraine. (Market Watch)

Two Executive Roles Announced for Vagus Nerve Stimulation Firm

April 28, 2014 - Cyberonics, Inc. has named its former senior vice president of strategic planning, Rohan Hoare, PhD, to the newly created role of chief operating officer for the company's epilepsy franchise. Cyberonics announced it has also recently names O'Neill F. D'Cruz, MD as Chief Medical Officer. The announcement described technology in its pipeline of vagus nerve stimulation products that focus on epilepsy: AspireSR™ pulse generator, with seizure detection and response technology, that has been CE marked in Europe; and the Centro™ and ProGuardian™ products that are anticipated to be nearing regulatory submissions. (Market Watch)

Consortium to Study Patient Preferences in Medical Devices

April 28, 2014 - The U.S. FDA announced http://us7.campaign-archive1.com/?u=cff97b5f3bf8acc54721b83b1&id=4e3f86eea4 it has awarded the public-private Medical Device Consortium $500,000 for a 12-month study of patient preferences regarding medical devices. The consortium formed in Minneapolic in 2012 as a partnership between the FDA and the medical device industry with the intent to improve how medical device safety is regulated. (Star Tribune)

Pediatric Dystonia Patients Receive Deep Brain Stimulation

April 28, 2014 - A girl who regained mobility after receiving deep brain stimulation for dystonia sat with her mother at a news conference while the doctor described the operation. She was one of six children treated at Phoenix Children's Hospital. (KTAR)

Review: Deep Brain Stimulation Reduces Symptoms of Treatment-Resistant Obsessive Compulsive Disorder

April 25, 2014 - Five randomized controlled trials of active vs. sham deep brain stimulation in obsessive compulsive disorder (OCD) through April 2013, comprising 44 subjects, indicate that the treatment had a significantly lower mean score in symptoms, representing partial remission of treatment-resistant OCD. However, there were significant adverse effects experienced in one-third of cases (16). (Psychological Medicine)

Interviewers Assess Impact of Patient's Approach to Being Referred to Deep Brain Stimulation for Parkinson's Disease

April 25, 2014 - Researchers interviewed 39 men and eight women who received deep brain stimulation (DBS) implants at the University Hospital of Northern Sweden between 2002 - 2010, and three additional female DBS patients to achieve a more gender-balanced sample. The results suggest that many patients "have to argue and struggle with their clinicians in order to be referred to a DBS-team," the authors write. They also believe that outlook and approach may contribute to a gender-skewed distribution of treatment. (BMC Neurology)

Combined Cochlear Stimulation and Nerve Growth Factor May Enhance Hearing, Animal Study Indicates

April 24, 2014 - Researchers at the University of New South Wales carried out studies in guinea pigs to see whether gene therapy can maintain the health of auditory nerves to enhance the dynamic range of cochlear implant stimulation while permitting a lower stimulus threshold. In deaf guinea pigs, the team used the phenomenon of electrically opening pores in the nerve cells to introduce naked DNA -- without a viral vector -- that codes for production of neurotrophin. As they report in Science Translational Medicine, the nerve growth factor was seen to influence nerve regeneration, so that the auditory nerve naturally grew toward the cochlea, improving the animals' hearing. (Medgadget)

Responsive Neurostimulation Called a "Welcome New Arrival" for Treatment of Medically Refractory Epilepsy

April 22, 2014 - A two-year followup on the capability to use responsive neurostimulation (RNS) to treat refractory epilepsy indicates, two co-authors write, that "long-term RNS treatment is safe, and that efficacy improves with time. . . . RNS is a welcome new arrival in the armamentarium of epilepsy treatments." (Nature Reviews Neurology)

Retrospective Study Looks at Spinal Cord Stimulation Conversion from Percutaneous Trials

April 23, 2014 - Using data from MarketScan, a database that contains longitudinal patient billing data for 170 million patients from 2000 - 2009, a medical student reported at the recent annual meeting of the American Association of Neurological Surgeons that 41.4% of U.S. patients had opted for a permanent spinal cord implant after a percutaneous trial. Conversion rates were higher in the North-Central and Southern states as opposed to the Northeast and West. (Medscape)

Company Offers Advanced Implantable Pulse Generator for Future Neuromodulation Devices

April 23, 2014 - A new implantable pulse generator (IPG) for next-generation neuromodulation devices is now available from Massachusetts-based AdvaStim, Inc., where developers say it provides tools to explore issues of neural adaptation. The IPG has a modular platform with embedded software that allows customization of output parameters for advanced waveform modes, such as modulating current amplitude and pulse duration, and allowing for multi-channel delivery of simultaneous, sequential or independent pulse rates. The architecture enables multi-channel switching, electrode programming, response to external sensor data, and suitability for shrinking form factors. (Businesswire)

Magazine Notes Shift in Deep Brain Stimulation Acceptance

May 2014 - A news feature about deep brain stimulation highlights a neurologist-neurosurgeon team who have worked since 2002 in Florida, saying the technique is "one of the most exciting treatments in modern medicine" and "it's easy to imagine a future where brain implants may become as common as hip replacements". (Smithsonian)

Preliminary Findings Presented About Spinal Cord Stimulation System Offering Additional Contacts

April 2014 - International Neuromodulation Society member Salim Hayek, MD, PhD, presented a retrospective study at the December 2013 annual meeting of the North American Neuromodulation Society INS chapter, in which more than 200 patients were trialed with the Boston Scientific Corporation Precision Spectra spinal cord stimulation system. The system allows for up to 32 contacts -- double what was previously available. Prospective and comparative effectiveness research studies have begun, and data from a three-month followup of 32 patients showed a drop in average pain score from 7.05 to 2.96. INS member Tim Deer, MD, was quoted as commenting that the three-month findings are interesting but a cost analysis and prospective data would provide more information. 

Profile of a Stanford University Professor Recaps Milestones in Optogenetics and Brain Mapping

April 21, 2014 - A feature in the New York Times describes the development of optogenetics, and profiles one contributor to its development, the Stanford University Professor of Bioengineering and of Psychiatry and Behavioral Sciences Karl Deisseroth, MD, PhD. The article is one of four news features about brain mapping that the newspaper has published in the past year, and it also mentions brain-mapping work that his team presented at the November 2013 annual meeting of the Society for Neuroscience in San Diego. (New York Times)

Husband and Wife with Chronic Pain Both Benefit from Receiving Spinal Cord Stimulators
April 18, 2014 - A husband and wife in Indiana who are in their 50s both had spinal cord stimulation systems implanted for chronic back pain and can now live more active lives and continue working. Their provider said the effects of neuromodulation are among the most dramatic in his pain practice. (News-Sentinel)

Korean Charity Agrees to Help Finance Vagus Nerve Stimulation for Children with Medically Refractory Epilepsy

April 17, 2014 - A charity group in South Korea agreed to provide support so that children with drug-resistant epilepsy can receive vagus nerve stimulation (VNS) to limit their seizures. Up to 25 patients will be supported each year, with priority to families that cannot afford medical care. The commitment will be for up to 2 million won (approximately $2,000 in U.S. dollars) in medical bill coverage per patient. The agreement was formalized in a memorandum of understanding between a medical society, the Korean Child Neurology Society, and a charity group, the Supporters Society for Korea Parents of the Disabled Association. Since April 2013 the charity group has already enabled eight pediatric patients to receive VNS implants. (Korea Times)

News Feature Describes Deep Brain Stimulation to Manage Symptoms of Movement Disorder

April 15, 2014 - In a news feature for Parkinson's disease month, Southern Illinois University School of Medicine neurosurgeon Jeffrey Cozzens, MD, a member of the International Neuromodulation Society, is interviewed about how some 80-90% of patients who meet criteria to receive deep brain stimulation to control tremors notice some improvement, even though the disease itself can still progress. Having performed more than 350 of these surgeries over the years, he remarked that these patients are his happiest and thrilled to "get their lives back". (Devils Lake Journal)

Profile Features Patient Who Received Robotic-Assisted Deep Brain Stimulation Surgery

April 15, 2014 - In a profile of a patient who received robotic-assisted deep brain stimulation surgery for essential tremor, a physician explains that the technology allows patients to be able to move a little and be more comfortable during the surgery, as well as shortening the time it takes to perform. (Florida Times-Union)

Device Maker's Earnings Report Anticipates Neuromodulation Growth

April 16, 2014 - In its first quarter 2014 earnings report, St. Jude Medical Inc. announced net sales increased 4% over 2013. Neuromodulation product sales were flat at $99 million compared to the same quarter one year ago, but CE mark approval and European launch of the Prodigy spinal cord stimulation system was explicated to be a future driver of growth. (Medical Product Outsourcing)

Article Centers on Importance of Training in Reducing Implant Risk

April 15, 2014 - A presentation submitted to an upcoming medical meeting by International Neuromodulation Society member Shivanand P. Lad, MD concerns data from 12,300 insurance claims for spinal cord stimulation implants that indicate almost one in 100 cases show some degree of spinal cord or spinal nerve-root damage, according to an article in the Wall Street Journal. INS member and journal Editor-in-Chief Robert M. Levy, MD, PhD was attributed to say that uneven training across medical specialties and a perception that such implants are easy to perform is often at the root of surgical complications. Among other sources, the article also quotes INS member Gilbert Fanciullo, MD, director of pain medicine at the Dartmouth-Hitchcock Medical Center, about the importance for practitioners to be familiar with implantation risks. (Wall Street Journal)

Primary Head Pain Case Series Examines Combined Occipital and Supraorbital Stimulation

April 15, 2014 - International Neuromodulation Society member Shannon Hann, MD, presented a case series at the American Association of Neurological Surgeons 82nd Annual Meeting in which 14 of 20 patients with medically refractory primary headache found pain relief of more than 50% through combined neurostimulation of occipital and supraorbital nerves over a mean followup of 34 months. Patients with facial pain developed allodynia and had to have the systems removed. She said the combined stimulation bears further investigation and on average appears that it may be more effective than occipital stimulation alone. (Medscape)

Urologists Stage Debate Regarding Overactive Bladder Treatment Options

April 14, 2014 - In a urology meeting debate concerning treatment with botulinum toxin or sacral neuromodulation for overactive bladder, sacral neuromodulation advantages mentioned included that it can enhance voiding and defecation, which may also present problems in these patients. (European Association of Urology)

Irish Neuromodulation Device Company Plans Initial Public Offering

April 9, 2014 - To fund ongoing development of its chronic back pain device to stabilize muscles of the lower spine, the Irish medical device company Mainstay Medical announced it plans an initial public offered on the Euronext market in Paris and Dublin’s junior Enterprise Securities Market to raise up to €26.4 million through sale of 851,175 shares. (Irish Times)

Patient Enrollment Starts in Deep Brain Stimulation Clinical Registry

April 10, 2014 - Boston Scientific Corporation announced enrollment of the first patient in a new registry of the Vercise(TM) Deep Brain Stimulation (DBS) System in patients with Parkinson's disease. Approved  for sale in Europe, Israel, Australia and select countries in Latin America, the system offers multiple independent current control and a Zero Volt(TM) battery designed for longevity. The registry will evaluate the system's clinical outcomes and the economic value. (Wall Street Journal)

Neuromodulation Company With Noninvasive Investigational Approach to Depression Expands Its Leadership Team

April 10, 2014 - In preparation for pivotal clinical trials of its low-field magnetic stimulation therapy for depression, Tal Medical, Inc. of Boston added Jan Skvarka as president, CEO and member of the board of directors, as well as Ben Shapiro, MD, also on the board of directors. The National Institute of Mental Health selected the technology for its RAPID treatment program evaluating novel rapidly acting antidepressant treatments. The company is preparing for multi-site clinical trials led by psychiatric researcher Maurizio Fava, MD, director of the Clinical Research Program at Massachusetts General Hospital. The trial will examine the efficacy and durability of the treatment over an extended period of time in patients with major depressive disorder. (Market Watch)

U.S. Neurostimulation Market Projected to Approach $4 Billion by 2022

April 9, 2014 - The value of the U.S. neurostimulation device market will approach $4 billion by 2022, according to the Decision Resources Group, due in part to first-time demand for replacement of implantable pulse generators in new patients -- as well as anticipated growth in chronic heart failure, obesity, and epilepsy. However, market penetration is still thought to be low generally "because many referring physicians are not exposed to neurostimulation in medical school." (Digital Journal)

Business Column Expresses Optimism for Industry Due to News of Neurostimulation Aiding Spine-Injury Patients

April 9, 2014 - A column by the Motley Fool says now that three paralyzed patients were able to move limbs through a combination of spinal cord stimulation and physical therapy, there should be potential optimism for investors and patients who could anticipate growth in the neuromodulation sector. The column points out that the implanted systems were manufactured by Medtronic, Inc. and mentions the latest business developments from St. Jude Medical and Boston Scientific Corporation. (Motley Fool)

Story Features Pediatric Patient Who Received Deep Brain Stimulation for Dystonia

April 8, 2014 - International Neuromodulation Society member John Honeycutt, MD, was interviewed about a 7-year-old girl who has always had dystonia and was able to start bicycling three months after she received a deep brain stimulation implant during a relatively new "asleep" procedure. (Ivanhoe Broadcast News)

Spinal Cord Stimulation in Four Spinal Cord Injury Patients Enables Voluntary Movement After Complete Paralysis
April 9, 2014 - Spinal cord stimulation allowed four people with paraplegia to move previously paralyzed muscles, according to a news release by the National Institutes of Health, which partially funded the study along with the Christopher & Dana Reeve Foundation. The research (also covered in the Wall Street Journal and other publications) was published Tuesday in the journal Brain. "Neuromodulation of the sub-threshold motor state of excitability of the lumbosacral spinal networks was the key to recovery of intentional movement," the authors write. (Los Angeles Times)

U.S. National Radio Broadcast Features Essential Tremor

April 7, 2014 - A woman who had deep brain stimulation for essential tremor 15 years ago was featured in a radio broadcast about the condition. She said she cried when stimulation was first applied and quoted her tremors, which have returned to a small degree but do not interrupt her life anymore. (NPR)

Restrospective Study Indicates Electrode Placement Affects Outcomes of Subthalamic Nucleus Stimulation

April 4, 2014 - Twenty-seven authors of a retrospective analysis of 309 patients who received deep brain stimulation of the subthalamic nucleus (STN) for Parkinson's disease in France report in Neurology that the STN is the best target to control motor symptoms, postoperative cognitive deficit is mainly related to the surgery itself, and hypomania induced by stimulation in 19 cases appears to stem from both the disease characteristics (younger age, shorter disease duration, higher levodopa responsiveness) and a more ventral location of the electrode in the STN. (News-Medical.Net)

FDA Approves First Spinal Cord Stimulation Implantable Pulse Generator Fashioned for Noninvasive Software Upgrades

April 4, 2014 - The FDA has approved St. Jude Medical's Protégé™ implantable pulse generator for spinal cord stimulation, the first such device to allow future technology upgrades through software updates. New stimulation modes -- such as the currently investigated burst mode -- diagnostic capabilities, or other features could be accessed noninvasively, without needing surgery. The device has a seven-year warranty and 10-year projected battery life. International Neuromodulation Society member Tim Deer, MD, was the first to implant the device, the smallest in its class. “In the first 40 years of SCS we’ve seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies,” he commented. (Enhanced Online News)

Vanderbilt Research Into Early-Stage Deep Brain Stimulation in Parkinson's Disease Enters Pivotal Clinical Trial

April 3, 2014 - International Neuromodulation Society members Peter Konrad, MD, PhD, and Joseph Neimat, MD, of Vanderbilt University are part of a long-term study of deep brain stimulation (DBS) in early-stage Parkinson's disease, which has moved into a large Phase III, multi-center safety and efficacy trial. (Vanderbilt)

Former Radio Host Expresses Gratitude for Access to Deep Brain Stimulation for his Parkinson's Disease

April 2, 2014 - A former resident of the U.S. who stopped hosting a radio show after developing Parkinson's disease describes in a radio interview how he got up out of a wheelchair and strolled down a hall after his deep brain stimulation implant was activated. He said he was grateful that the government in Canada covered the cost of the therapy, voicing concern that it might have been costly for him to try to obtain in the U.S. (CBC Radio)

Review Details Expanding Uses of Peripheral Nerve Stimulation

May 2014 - International Neuromodulation Society member Teodor Goroszeniuk, MD and co-author David Pang, FRCA write in a review of peripheral neuromodulation that new technologies for more easily and safely placing electrodes percutaneously should further expand its uses; in addition to intractable headache, uses include neuropathic, visceral, cardiac, abdominal, low back and facial pain. Also under extensive investigation is its use in modulating organ function in treatment of syndromes such as epilepsy, incontinence and obesity with vagal, tibial and gastric stimulation. (Current Pain and Headache Reports)

Study Presented About Heating of Conditionally Safe Spinal Cord Stimulation Leads During MRI Full-Body Scans

April 2, 2014 - Medtronic Inc.'s principal electrical engineer, Heather Orser, PhD, presented a poster at the American Academy of Pain Medicine Annual Meeting in March regarding safety of a new full-body, conditionally MRI-safe spinal cord stimulation lead. Based on animal data and simulations of lead paths in human models -- combined with lead characterization analyses -- the results showed that the design for reduced radiofrequency-induced heating produced temperatures below 43º C for the full range of scenarios during 30 minutes of active scanning. (Healio)

Company's Progress Reflects Northern Ohio's Growing Neurostimulation Industry

April 1, 2014 - Ohio-based Neuros Medical, Inc. was featured in an article about the regional industry for electrical stimulation technology to address "spinal cord injury, stroke, bladder incontinence and chronic pain." International Neuromodulation Society member Amol Soin, MD, was quoted about a pilot study of the company's Altius high-frequency nerve block device for limiting amputation pain. He anticipated the device might be commercially available within two years. (Cleveland.com)

Florida Hospital Uses Robot-Assisted Surgery for Implanting Deep Brain Stimulation Electrodes

March 31, 2014 - The Baptist Health medical center in Jacksonville, Florida has begun using the Mazor Robotics Renaissance Guidance System to perform bilateral deep brain stimulation. A patient who received the procedure for his essential tremor described how the implant helps control his symptoms. (First Coast News)

Noninvasive Brain Stimulation Platform Allowed Further Patent Claims

 March 31, 2014 - Soterix Medical Inc. of New York City announced an allowance of patent claims for controlling the targeting of high-definition transcranial direct current stimulation. The company says its technology combines the advantages of transcranial direct current stimulation and transcranial magnetic stimulation. The non-invasive system is being trialled in applications spanning depression, pain, epilepsy and stroke rehabilitation. The company uses individualized brain current-flow modeling and patented algorithms for placing and energizing high-definition electrodes on the scalp. (Digital Journal)

 

Growth-Stage Company Adds Chief Medical Officer

March 31, 2014 - Nevro Corp. announced appointment of David Caraway, MD, PhD as its chief medical officer. A member of the International Neuromodulation Society, Dr. Caraway is a pain management physician who has been active in developing the field of neuromodulation. Nevro's high-frequency spinal cord stimulation system, Senza, is authorized for sale in Europe and Australia. (Digital Journal)

 

Researchers Watch Neuroplastic Response of Brain Networks to Cortical Stimulation

March 31, 2014 - Researchers in Japan combined repetitive transcranial magnetic stimulation and diffusion-weighted MRI to observe plasticity-related changes in brain regions that are affected through neural networks by the stimulation, but are not themselves stimulated. (Medical Xpress)

 

Neuromodulation Device Early Stage Company Expands Its Financial Management Team

March 28, 2014 - Los Angeles-based NeuroSigma, Inc. has expanded its management team with two former Amgen finance executives. Carl Adams, who was briefly the company's controller and vice president, was promoted to chief financial officer.Craig Rostamian was appointed vice president of Finance, where he will oversee financial planning and analysis. NeuroSigma has Health Canada and CE Mark approval to market its external trigeminal nerve stimulation system, the Monarch™ eTNS™ System, for the adjunctive treatment of drug-resistant epilepsy and major depressive disorder for adults and children 9 years and older. (Wall Street Journal)

Girls Promote Epilepsy Awareness and Discuss Vagus Nerve Stimulation

 March 28, 2014 - A student who received a vagus nerve stimulator two years ago to help control her epileptic seizures, and her younger sister, participated in an annual worldwide Purple Day campaign to raise awareness by telling of their experiences with the condition. The young woman has gone three months without a seizure and would like to be eligible for a driver's learning permit if she goes six months seizure-free. (Cowichan Valley Citizen)

 

Study: Disparities in Deep Brain Stimulation for Parkinson's Disease

March 2014 - An examination of  2.4 million discharges for Parkinson's disease from 2002 - 2009, conducted through hierarchical multivariate analysis of the Nationwide Inpatient Sample, showed that although 4.7% of all Parkinson's disease discharges were of African American patients, only 0.1% of the Parkinson's disease discharges among African Americans were for deep brain stimulation (DBS), indicating a disparity in access to this care. The study authors say that even though African American patients are more often discharged from urban teaching hospitals with a higher-than-average density of neurologists, the patients received disproportionately fewer DBS procedures than their non-African American counterparts. (JAMA Neurology)

France Issues Neurostimulation Health Technology Assessment
March 27, 2014 - Chronic neuropathic pain, complex regional pain syndrome, and ischemic pain are considered indications in which neurostimulation can play a treatment role, according to a health technology assessment just published by the French commission for evaluation of medical devices and health technologies. (Vidal)

 

Fibromyalgia Study Links Repetitive Transcranial Magnetic Stimulation to Improved Quality of Life

March 26, 2014 - In a small, double-blind study in France, 38 fibromyalgia patients either received sham stimulation or repetitive transcranial magnetic stimulation to the left primary motor cortex. After 14 stimulation sessions over 10 weeks, the patients were assessed for quality of life. In addition, PET scans were periodically performed throughout the treatment period. The study found that patients receiving active stimulation reported an improved quality of life and also had an increase in metabolism in the right limbic area. The study authors report in Neurology that the study provides Class II evidence for effectiveness of the intervention. (Health Day)

 

Vision-Restoration Startup Names New Chief Executive Officer and Director

March 25, 2014 - Khalid Ishaque, most recently general manager of Boston Scientific's international neuromodulation business, has been named chief executive officer and director of a Paris company that works on retinal implants to restore sight, Pixium Vision. Pixium has a surface-retinal-implant system, IRIS®, that entered a clinical trial in 2013 with initial patient data expected in 2014 to form the basis of a CE Mark application. The company is also developing a sub-retinal implant system, PRIMA™. Formed in 2011 based on research from the Vision Institute and Université Pierre et Marie Curie, the company incorporates academic research from the U.S. and Europe, and has raised €24.5m from venture capital and investment firms including Sofinnova Partners, Omnes Capital, Abingworth, Global Life Sciences Ventures, Bpifrance, Seventure and Polytechnos. (Pixium Vision) 

 

Neuromodulation Startup Raises $32.6 Million in Series A Funding

March 25, 2014 - Axonics Modulation Technologies of Irvine, Calif. has raised $32.6 million in a Series A preferred stock financing led by Edmond de Rothschild Investment Partners of Paris, with participation by NeoMed Management of Genveva, and Legend Capital of Beijing as well as a number of private investors. The company is developing novel implantable neuromodulation technology licensed from The Alfred Mann Foundation. Initially the company will focus on chronic pain and overactive bladder. Among the company's leaders is co-founder and medical advisor Timothy Deer, MD, a member of the International Neuromodulation Society. (Fierce Medical Devices)

Technology Assessment Forum Seeks Comment on Migraine Treatment Options

March 25, 2014 - The California Technology Assessment Forum will take written comments prior to a public meeting July 11, 2014 in Los Angeles to examine treatment options for migraine headaches, including a newly approved, hand-held device that provides transcranial magnetic stimulation. The forum is intended to provide guidance to clinicians, insurers and patients. (Institute for Clinical and Economic Review)

Firm Announces First Use of Its Technology for Asleep Deep Brain Stimulation Surgery

March 25, 2014 - Mazor Robotics Ltd. announced the first deep brain stimulation surgery using its Renaissance® Guidance System with the patient asleep. The surgeon in charge of the operation said the system allows the patient to have less anxiety and the procedure to be performed more quickly with fewer probes into the brain. The operation in Littleton, CO took place on a 65-year-old man who was recently diagnosed with Parkinson's disease. (Mazor Robotics)

U.S. Patient Describes Her Heart Failure Symptom Improvement with Vagal Nerve Stimulation Device

March 24, 2014 - A woman who is controlling heart failure symptoms with investigational use of a CardioFit (TM) vagal nerve stimulation device by BioControl Medical is interviewed on Florida television. (WJXT - Jacksonville)

Motor Cortex Stimulation Shown to Improve Training in Controlling Robotic Arm through Brain Interface

March 24, 2014 - Collaborators at the University of Tubingen and National Institutes of Health report that training healthy subjects to use a brain-machine to control a robotic arm went better with electrical stimulation to the primary motor cortex than in a control group that did not receive that stimulation. As a follow-up, the procedure will next be tested in stroke patients. (Medical Xpress)

First Patients Begin to Receive New Responsive Neurostimulation System for Epilepsy

March 24, 2014 - Epilepsy specialists and patients discuss use of NeuroPace's RNS System and the advantages of responsive neurostimulation in controlling seizure activity, compared to the previously available option of continual vagus nerve stimulation. (New York Times)

 

Auditory Brainstem Implants May Slowly Become Less Rare

March 24, 2014 - More investigation in Europe in patients with congenital disease or trauma led to exciting results that spurred expanded interest in the U.S. for auditory brainstem implant which has been performed about 1,000 times worldwide in the last 30 years. Centers experienced in removing acoustic neuromas -- one main reason to seek the intervention -- may offer the technology. The capability is now offered in Northern Ohio at the University Hospital Case Medical Center and at the Cleveland Clinic. The House Clinic in Los Angeles developed and honed the procedure and performed the bulk of implantations in the U.S. (Cleveland.com)

 

Business Column Explores Positive News of CE Mark Approval for Neuromodulation Device

March 21, 2014 - Recent CE Mark approval for St. Jude Medical's Prodigy neuromodulation device should help the company in light of declining sales of pacemakers and ICDs and competition from Medtronic, Inc. and Boston Scientific Corporation, a column in the Motley Fool says. The column mentions that the company estimates more than 1.5 billion people worldwide suffer from chronic pain, so the market for devices like the Prodigy is potentially huge. Also, the column calls neuromodulation "an up-and-coming field" in medical technology. (Motley Fool)

 

FDA Approves Implant for Sensorineural Hearing Loss

March 20, 2014 - The FDA approved the first implanted device for severe or profound sensorineural hearing loss -- the most common type -- for patients for whom standard hearing aids are ineffective. The device, the Nucleus Hybrid L24 Cochlear Implant system, combines elements of conventional cochlear implants and hearing aids. Manufactured by Cochlear Ltd. of Australia, the device os intended for use in just one ear to improve the ability to hear middle or high frequencies. Approval was based on a clinical study of 50 people. (Health Day)

 

Burst Spinal Cord Stimulation Technology Receives CE Mark Approval

March 20, 2014 - St. Jude Medical, Inc. announced CE Mark approval and European launch of its spinal cord stimulation (SCS) system, Prodigy™, that offers both tonic and burst stimulation for expanded therapy options. The rechargeable SCS system is subject to a U.S. clinical trial, SUNBURST™ (Success Using Neuromodulation with BURST) http://clinicaltrials.gov/ct2/show/NCT02011893. (St. Jude Medical)

Implants That Sense Neural Signals are Leading to Understanding of Brain Circuits

March 19, 2014 - Deep brain stimulation systems that can read out neural signals are contributing to studies into patterns that correlate with different symptoms of Parkinson's disease, potentially leading to creation of more tailored, responsive neurostimulation regimes. (Nature)
 

Retrospective Study Ranks Which Specialists Refer Chronic Pain Patients to Spinal Cord Stimulation the Soonest
March 18, 2014 - International Neuromodulation Society member Krishna Kumar, MD said in an interview about a retrospective study of 532 patients who received spinal cord stimulation (SCS) that while SCS should be considered within the first 12 - 16 weeks of chronic pain (prior to changes occurring within the brain) to improve success rates, referrals varied by specialty, with neurosurgeons on average referring after 2.69 years, and orthopedic surgeons and anesthesiaiologists referring after 4.30 and 4.84 years, respectively. (Medscape)

Company Ships Next-Generation Device for Diabetic Pain
March 18, 2014 - A transcutanteous electrical stimulation system designed to relieve neuropathic pain during sleep has been released in its second-generation form by NeuroMetrix, Inc. The company's Sensus (TM) pain management system is intended for diabetics who have chronic pain, such as from painful diabetic neuropathy. In its second iteration, the device is thinner than the previous device released in 2013, and has several hardware improvements. (Wall Street Journal)

  

Woman with Auditory Nerve Damage First in Northeast Ohio to Receive Auditory Brainstem Implant

March 13, 2014 - A woman who lost hearing due to benign tumors received an auditory brainstem implant (ABI) at University Hospitals Case Medical Center in Cleveland. In an announcement, a medical school professor was quoted as saying the effectiveness of ABI is limited. After the device is turned on in 6-8 weeks, she will undergo rehabilitation therapy to maximize the benefit of the additional sense of sound provided by the device. She was the first in Northeast Ohio to receive an ABI. Her surgeons consulted with the Los Angeles-based House Ear Clinic, which has performed the bulk of these surgeries nationally since their development in the 1970s. (Newswise)


Peripheral Nerve Stimulation Helps Man's Chronic Knee Pain

March 13, 2014 - A 42-year-old man who has suffered more than 16 years of knee pain due to accidents and osteoarthritis, considered too young to receive a joint replacement that may last only 20 years, was given a peripheral nerve stimulation implant after a successful trial. This was considered an uncommon application of the fairly common pain intervention. (Chicago Tribune)


Research Funding Announced for Study of Brain Stimulation in Stroke Rehabilitation

March 13, 2014 - The National Institute of Child Health and Human Development has given a $1.5 million grant to a faculty member at the University of Illinois at Chicago's Brain Plasticity Lab to compare gait training with or without brain stimulation in patients who have experienced a stroke. The neuromodulation treatment group will receive transcranial direct current stimulation in advance, and electrical stimulation in combination with motor training of the ankle. The investigator will also use MRI to see if there were any changes in cortical activity associated with the therapy. (Phys.org)

 

FDA Approves Device For Preventing Migraine Attacks

March 11, 2014 - The FDA announced it has given its first approval to a transcutaneous electrical nerve stimulation device meant to be used prior to the onset of pain -- the Cefaly headband-like device that stimulates the trigeminal nerve above the eyes. Designed to prevent migraines by being used daily for 20 minutes, the device is available by prescription, and may help patients who cannot tolerate migraine-prevention medication. Approval was based on a clinical study of 67 individuals in Belgium who experienced fewer migraines through its use, as well as a study of 2,313 users in France and Belgium, 53% of whom said they were satisfied and willing to buy the device for continued use. Cefaly is manufactured by STX-Med in Herstal, Belgium. (FDA)


Cardiologist Describes Neurostimulator Undergoing Clinical Trial in Heart Failure

March 11, 2014 - Patients who are not making progress having given current treatment a chance would be potential candidates for heart failure treatment using an implanted neurostimulator to treat the parasympathetic nervous system, a cardiologist says in a question-and-answer section accompanying an article about the first patient in Florida to receive the CardioFit™ nerve stimulator in a U.S. clinical trial of the device, which is approved for marketing in Europe. The device from Biocontrol Medical combines a sensor in the heart and stimulator on the vagus nerve. (Ivanhoe Newswire via WWSB)

 

High-Frequency Spinal Cord Stimulation Study Publishes Data from Two-Year Follow-up

March 11, 2014 - Twenty-four months of results were published in the March 2014 issue of Pain Medicine regarding a prospective European clinical study of high-frequency spinal cord stimulation for chronic, refractory low-back and leg pain. In the study of Nevro Corp.'s Senza system, back pain was reduced from an initial 8.4 out of 10.0 to 3.3, and leg pain was reduced from 5.4 out of 10.0 to 2.3. Of 82 patients trialed, 72 went on to permanent implants and 65 were available for a two-year follow-up. In addition to reduced pain, patients reported increased function, better sleep, and decreased opioid use. Adverse events resembled those seen with traditional spinal cord stimulation. Senza is authorized for sale in Europe and Australia, supported by European data published in Pain Medicine and in Neuromodulation: Technology at the Neural Interface in 2012. In the U.S., the system is undergoing a pivotal randomized controlled clinical trial, with enrollment completed one year ago of 241 patients at 11 pain treatment centers. (PR Newswire)

Vagus Nerve Stimulation System Company Receives Positive Investment Analysis
March 10, 2014 - An investment analyst issues a positive report on the company Cyberonics, Inc., explaining that up to one-third of epileptic patients do not respond to medication, and that the Houston, TX company's implantable vagus nerve stimulation (VNS) system for treatment-resistant epilepsy has been implanted in more than 75,000 patients since 1997. The company recently released a VNS device that activates in response to abnormal heart rhythms associated with seizures. The analyst said one study showed that in about 62 percent of activations seizures were diminished or halted, adding that the cost of the device and Medicare reimbursements are climbing, while VNS saves an estimated $60,000 in treatment-related expenses. (Investing Daily)

 

Patient Recruitment Starts in Australia for Clinical Trial of Novel Back-Pain Stimulator

March 10, 2014 - Australia has cleared Mainstay Medical to begin a clinical trial of an implantable neurostimulation device for chronic low back pain, ReActiv8, which stimulates nerves that contract key muscles that stimulate the lower back. Patient recruitment has begun at three clinical trial sites in Australia. In June 2013, Mainstay presented results at the world congress of the International Neuromodulation Society regarding the company's recently concluded European Feasibility Study. (Medical Device Business Review)


Transcranial Magnetic Stimulation Company Raises Private Capital in Israel

March 9, 2014 - Brainsway Ltd. has raised NIS 41 million (US $11.9 million) in a private-equity placement. The investment house Yelin Lapidot received 772,585 of the company's shares (5.48%) in the exchange. Brainsway will apply the proceeds to market expansion for its Deep TMS (transcranial magnetic stimulation) system for neurological/neuropsychiatric disorders. (Globes)


India Starts Fellowship for Affordable Medical Technology Innovation

March 8, 2014 - A technology accelerator in India, InnAccel, has started a six-month fellowship program on Affordable Innovation in Medical Technology to train engineers and product designers in medtech invention and entrepreneurship. The first three fellows are undergoing two months of clinical observation at the trauma and emergency care unit at St. Johns National Academy of Health Sciences in Bengaluru, which already has a number of med-tech start-ups and venture capitalists, as well as a presence by multinational companies like GE Healthcare, Phillips and Siemens. (Pharmabiz.com)


Pain Registry Provides Evidence for Neuromodulation Therapy

March 7, 2014 - The Partnership for Advancement in Neuromodulation has published interim results of its pain registry in early view in Neuromodulation: Technology at the Neural Interface. The data from 579 patients at 40 study sites showed patient-reported pain relief was 58% at three months, 58% at six months, and 57% at 12 months. Slight more than 47% of patients stopped or decreased opioid use, while smoking was shown to significantly attenuate pain relief. (MDLinx)

 

Retrospective Analysis Indicates Spinal Cord Stimulation Success Increases When Started Within Two Years

March 6, 2014 - International Neuromodulation Society member Krishna Kumar, MD, presented a poster at the annual meeting of the American Academy of Pain Medicine showing that in 443 patients with chronic pain, those who waited less than 2 years for spinal cord stimulation had a 75% success rate, compared to 15% for patients who waited 20 years,  (American Academy of Pain Medicine)


Clinical Trial Starts That Pairs Audio Tones and Vagus Nerve Stimulation to Reduce Tinnitus Symptoms

March 6, 2014 - The National Institutes of Health is starting a study that pairs vagus nerve stimulation and exposure to audio tones to try to reduce symptoms in patients who have moderate to severe tinnitus. The vagus nerve stimulation, provided by a device manufactured by MicroTransponder, Inc., is supposed to help re-wire the brain in response to the audio stimulation that is intended to reduce the perception of ringing in the ears that occurs in tinnitus. The clinical trial at four U.S. centers involves daily 2.5-hour sessions over six weeks. (Health Day)

 

Company Formed to Commercialize Implantable System Conducive to Infusion of Biologic Agents

March 6, 2014 - The Alfred Mann Foundation announced creation of a Minnesota-based life sciences company to commercialize an implantable infusion pump that provides capability for delivery of large molecules associated with emerging biologic therapies for neurodegenerative diseases. The new company, Medallion Therapeutics, is conducting a pivotal clinical evaluation for pre-market approval of the device in the United States, and is pursuing CE Mark certification in Europe. The foundation said in a news release that the technology is the result of more than 10 years of development, and could address unmet need and expand indications for implantable drug delivery. International Neuromodulation Society member Don Deyo, a seasoned industry executive, is chief executive officer, and Eric S. Harris, also an industry veteran, is chief commercial officer. (Jewish Business News)

 

Physician Describes New Experiences with Auditory Brainstem Implants in Children

March 4, 2014 - An interview, an implanting physician describes the intricacies of new work in the United States with auditory brainstem implants for children who lack the neural structures for a cochlear implant. Three pediatric patients have been implanted so far by Craig Buchman, MD, professor of Otolaryngology and Head and Neck Surgery at the University of North Carolina School of Medicine, who directs the university's Ear and Hearing Center. (Ivanhoe Newswire via My Suncoast)


Transcranial Magnetic Stimulation Research Indicates Greater Plasticity in Brains of Insomniacs

March 4, 2014 - A research study comparing the ease of training insomniacs on a motor task to controls suggests that insomniacs may have a more-plastic brain. The study used transcranial magnetic stimulation (TMS) to the motor cortex to trigger a thumb movement. Subjects were asked to learn to counter the movement. Although it was hypothesized that insomniacs would be less-rested and do more poorly, they surprisingly did better, suggesting there is an association between this plasticity and "dysregulation of arousal" seen in insomnia. Potentially TMS might be used to treat insomnia, according to the author of the study at Johns Hopkins University. (Live Science)


Texas Medical Center Initiates Study of Emerging Deep Brain Stimulation Target in Treatment-Resistant Depression

March 4, 2014 - A clinical trial is starting at the University of Texas Health Science Center at Houston in which five adults with treatment-resistant major depression will receive deep brain stimulation to the supero-lateral branch of the medial forebrain bundle, part of the brain's reward system between the limbic system and prefrontal cortex, an area that showed promise in a Bonn-based pilot study in seven patients in which preliminary findings were published in June 2013. (Newswise)

 

Concern About Medicare Distinctions Potentially Curbing Research into Deep Brain Stimulation

March 3, 2014 - International Neuromodulation Society member Andre Machado, MD, PhD, and co-authors point out that a centralization of Medicare reimbursement policies for investigational medical devices, instituted in January 2014, offers two investigational device exemption categories, neither of which balances well reflecting potential therapeutic risks of applying these devices to emerging targets and indications while also being conducive to investment in development of these therapies. (Journal of the American Medical Association)


Deep Brain Stimulation Associated with Neural Stem Cell Proliferation in Parkinson's Disease Patients

March 3, 2014 - A comparative post-mortem tissue examination of the brains of individuals without Parkinson's disease, those with Parkinson's disease who did not receive deep brain stimulation (DBS), and 12 patients who had idiopathic Parkinson's disease and received deep brain stimulation from 0.5 - 6 years before dying of other causes showed that there was a 2-6 fold greater cell proliferation in the subventricular zone of the lateral ventricles, an area of neural stem cell growth that lies close to the electrode trajectory, in the brains of the subjects who had DBS. The results suggest DBS may increase cellular plasticity, potentially in areas beyond the electrode location. The effects on Parkinson's disease symptoms and therapy are not clear. (PLoS ONE)


Effects of "Asleep" Deep Brain Stimulation Surgery Comparable Over Time to "Awake" Method for a Common Parkinson's Disease Brain Target

March 3, 2014 - Of 213 patients who received deep brain stimulation surgery targeting the subthalamic nucleus for management of Parkinson's disease symptoms while under general anesthesia, 188 were followed up after one year and 65 after five years. The resulting short-term and long-term motor effects were similar to intervention under local anesthesia, the authors state, and there were no more adverse effects. (Journal of Neurology, Neurosurgery & Psychiatry)

 

Neuromodulation: Technology at the Neural Interface Adds an Enhanced Article Web Interface

March 3, 2014 - The International Neuromodulation Society journal, Neuromodulation: Technology at the Neural Interface, has added a new Enhanced Article (HTML) viewing option, accessible for logged-in readers from the Table of Contents page, that facilitates online viewing on any mobile interface, from as small as the screen of a smart phone to larger-sized devices. Called "Anywhere Article," the capability from publisher Wiley-Blackwell also allows readers to offer feedback or suggestions about the new display option. INS and chapter members may read the journal by logging in at http://www.neuromodulation.com/login and clicking on the image of the journal at the member menu item "Read Neuromodulation Journal Online" (International Neuromodulation Society)

 

Researchers Describe Early-Stage Neurostimulation Research in Anorexia Nervosa

March 3, 2014 - The start of a Phase II trial of deep brain stimulation in anorexia nervosa, is described by Toronto-based researchers who have implanted 15 adults with chronic, treatment-resistant, or malignant cases of the eating disorder. Based on experience tracking response in depression to stimulation of the anterior cingulate, the team is focusing on the subcallousal cingulate of the anterior cingulate, noting that mood appears to be involved in the pathogenesis of anorexia nervosa. Another six patients have been enrolled and were awaiting surgery. (Psychiatric Times)


Biological Chemist in Munich Publishes Research Papers on Potential "Light Switches" for Sensory Processing

 March 2, 2014 - A biological chemist has developed a light-sensitive compound, DENAQ, that acts on specific ion channels in response to white light, which has allowed it to restore light-sensitivity in the eyes of blind mice. The research on electrophysiological remodeling of mouse retinal ganglion cells was published Feb. 19, 2014 in Neuron; in Angewandte Chemie on Feb. 12, 2014, his research group showed that the painkiller fentanyl, when modified with an azobenzene unit, will bind opioid receptors and change shape when exposed to different frequencies of light, activating or deactivating receptor function. (Ludwig-Maximilians-Universität München)

 

Study: Intensity, Not Area, of Spontaneous Neuropathic Pain Linked to Quality of Life

March 1, 2014 - International Neuromodulation Society member Kaare Meir, MD, PhD and colleagues in Denmark studied 26 chronic pain patients who received spinal cord stimulation, measuring both the area of spontaneous neuropathic pain and the pain intensity. The study found a correlation in increased quality of life with decreased pain intensity, but not with decreased area of spontaneous pain. (Clinical Journal of Pain)

Authors Give Overview of Neuromodulation Approaches in Cocaine Addiction

March 2014 - Repetitive transcranial magnetic stimulation (rTMS), deep rTMS, and deep brain stimulation are discussed as possible interventions for cocaine dependence in an article that also suggests potential genetic markers for risk and objective treatment outcome measures. (Addictive Disorders & Their Treatment)

External Brain Stimulation Elicited Brief Increase in Awareness in Brain-Injured Patients

Feb. 26, 2014 - Using low-level transcranial direct current stimulation that makes neurons more or less likely to fire, a clinical research team was able to elicit briefly increased levels in awareness in 15 of 55 study subjects who had shown fluctuating awareness ("minimally conscious state") or an ability to be aroused but not aware (vegetative state). In the crossover trial published online in Neurology, patients received 20 minutes of active or sham stimulation to the dorsolateral prefrontal cortex one day, and then crossed over to sham or active stimulation, respectively, the next. The responders included 13 brain-injury patients who were in minimally conscious state and 2 who had been classified as being in a vegetative state. (New Scientist)

Chronic Pain Advocacy Organization Re-emerges

Feb. 20, 2014 - The National Pain Foundation has re-emerged as a nonprofit organization, having transferred its assets to the American Pain Foundation in 2010, which disbanded in 2012. The National Pain Foundation announced a goal of creating a "digital footprint" of people in pain, their behaviors, treatments, and needs -- through online communities, surveys and forums. (Pain Medicine News)

Special Report Focuses on Four Global Neuromodulation Companies

Feb. 25, 2014 - Saying neuromodulation is poised for major growth in the coming years, Fierce Medical Devices provides an overview of the four main global competitors -- Medtronic, Inc., Boston Scientific Corporation, St. Jude Medical, and Cyberonics, Inc. Part of the anticipated growth, the article says, would come from wider and long-term use of neuromodulation therapies. (Fierce Medical Devicesl)

Neurostimulation Technique for Chronic Migraine to be Offered at Arizona Facility

Feb. 20, 2014 - International Neuromodulation Society member Jonathan Carlson, MD, will be offering a peripheral nerve stimulation technique for chronic migraine in the Phoenix, Arizona area, according to a news release from the Migraine Treatment Centers of America. (Digital Journal)

Vagus Nerve Stimulation in Response to Seizure Detection Receives CE Mark

Feb. 20, 2014 - Cyberonics, Inc. has received CE Mark approval for its 6th-generation generator for vagus nerve stimulation, the AspireSR generator, which provides automatic stimulation in response to detection of a seizure as indicated by an increase in heart rate. (Wall Street Journal)

Presentation Recaps Advantages of Brain Stimulation During Stroke Recovery

Feb. 20, 2014 - Stroke patients who receive brain stimulation and occupational therapy recovered more than twice the arm and hand movement six months after their stroke than those who received occupational therapy alone, according to research presented at the American Stroke Association's International Stroke Conference 2014. (Clinton Herald)

External Vagus Nerve Stimulation Company Featured in Business Column

Feb. 20, 2014 - A columnist calls electroCore's external vagus nerve stimulation system "digital health's big secret" and adds that the company is working on a screening tool to predict responders. (Forbes)

Vagus Nerve Stimulation Company Plans Business Presentations

Feb. 19, 2014 - Cyberonics, Inc.'s Chief Financial Officer Greg Browne will meet individually with investors and participate in a neuromodulation panel discussion in New York City next week. The panel takes place Feb. 26 at the Citi 2014 Global Healthcare Conference. On March 11, the company's president and chief executive officer, Dan Moore, will present at the Barclays Global Healthcare Conference in Miami, with a live audio webcast available from the company's website, http://www.cyberonics.com, at 2:30 PM Eastern Time. (Market Watch)

Researchers Look at the Role of Inflammatory Mediators in Response to Deep Brain Stimulation Surgery in Major Depression

Feb. 18, 2014 - Animal research and evaluations of patients who received deep brain stimulation for treatment resistant depression indicate that immediate symptom relief is mediated by local inflammation, suggesting that post-surgical analgesics that are not anti-inflammatory would be preferable, say researchers from the University of Cadiz, Spain. They are trying to discern the molecular effects in case the therapeutic effect can be replicated less invasively. In May 2013, the team published findings in Molecular Psychiatry, "Early responses to deep brain stimulation in depression are modulated by anti-inflammatory drugs". (Medical News Today)

Transcranial Direct Current Stimulation Studies Underway to Increase Alertness When Monitoring Battle Zones

Feb. 18, 2014 - The importance of quickly processing and acting upon information during military conflicts is prompting military funding of research into transcranial direct current stimulation as a potential way to enhance cognitive alertness, according to an article and accompanying graphic in the Boston Globe. The New York Daily News said the soldiers in the tests were kept awake for 30 hours and reviewed digital surveillance or footage from drones. The volunteers in the five tests at Air Force Research Laboratory at Wright-Patterson Air Force Base in Ohio reportedly performed twice as well with active stimulation. (Boston Globe)

Developers Announce Low-Power Circuit for Body-Area Networks

Feb. 18, 2014 - A power-efficient wireless transceiver circuit for use in body area networks for medical applications that adheres to the 400MHz-band international standard has been developed by Fujitsu Laboratories Ltd. and imec Holst Centre. Rather than require more than 12 milliwatts to monitor brainwaves or other vital signs as typically is needed, the circuit power requirements are reduced by more than a factor of 10 to 1.6mW for receiving data and 1.8mW for transmitting. (Today's Medical Developments)

Peripheral Nerve Stimulation for Chronic Headache Reviewed

Feb. 14, 2014 - In a review, the current evidence for peripheral neurostimulation is summarized for treatment of chronic migraine, trigeminal autonomic cephalagias and occipital neuralgia, and other secondary headache disorders. (Headache - The Journal of Head and Face Pain)

Transcranial Direct Current Stimulation Product Manufacturer Opens Boston-Area Office

Feb. 13, 2014 - Neuroelectrics, a Spanish spinoff of Starlab Neuroscience Research, has opened its first U.S. office, which is based at the Cambridge Innovation Center in Massachusetts, where it will be near research laboratories that may use its non-invasive brain stimulation research products, a transcranial direct current stimulation device, Starstim, and a wireless EEG brain monitoring device, Enobio. (BioFlash)

Noninvasive Brain Stimulation System Company's System is Installed in Sweden

Feb. 17, 2014 - Brainsway Ltd. announced it has installed deep transcranial magnetic stimulation systems at Karolinska University Hospital for depression treatment. The Swedish health system is public, the company noted, enabling more access to this mode of treatment than in the U.S. (Globes)

Brain-Computer Interface Award Submissions Sought

February 2014 - The International Annual BCI Award submission deadline is July 1, 2014; the award -- $3,000 -- recognizes outstanding, innovative research in brain-computer interfaces and has been supported since 2010 by the Australian BCI equipment supplier g.tec. (g.tec medical engineering GmbH)

Neuromodulation Research Grant Proposals for Parkinson's Research Due Next Month

February 2014 - Up to two years of funding for neuromodulation research into Parkinson's disease to relieve motor symptoms is offered by the Michael J. Fox Foundation for Parkinson's Research. Pre-proposals are due March 19. Ideal proposals involve clinical research or late-stage preclinical research in non-primates. The call for proposals calls deep brain stimulation a viable therapeutic option that provides benefit at low risk in appropriate patients although noting that the varying efficacy and side effects among subjects limits its full potential. (Michael J. Fox Foundation for Parkinson's Research)

Insights About Biomarkers of Depression Expand Future Treatment Options

Feb. 13, 2014 - An overview of new treatments for depression in Current Psychiatry mentions neuromodulation approaches and discusses theories about differences in neuron density; feedback pathways, and the role of stress in inflammatory response and cell turnover. (Medical Xpress)

Crossover Study Shows Benefit of Sacral Neuromodulation in Irritable Bowel Syndrome Patients Who Respond to a Percutaneous Trial

Feb. 6, 2014 - Surgeons from the Neurogastroenterology Unit at Aarhus University in Denmark report that in a randomized, controlled crossover study of sacral nerve stimulation (SNS) for irritable bowel syndrome (IBS), IBS-specific symptoms were significantly reduced during stimulation in the 21 participants, and conclude that SNS improves quality of life for highly selected IBS patients. The study subjects had a minimum baseline IBS symptom score of 40 points, reduced at least 30% during a percutaneous nerve evaluation prior to implantation. At one-year follow-up, the median IBS symptom sore had dropped from 62 to 25. (Annals of Surgery)

Authors Present 15-Year Follow-up on Prevention of Percutaneous Lead Migration

Feb. 11, 2014 - International Neuromodulation Society member Richard North, MD and co-authors report a retrospective series of patients in which percutaneous lead anchors were secured with a small amount of adhesive in 291 patients from 1998 to 2006. When one case of migration was observed involving a short anchor, from 2007 to 2013, in 142 consecutive patients, only a long anchor was used and a fascial incision was added to accommodate its tip, as well as stronger suture material. With a mean follow-up of 2.86 years, no migration was observed in the second set of patients; in the first series, over a mean follow-up of 4.75 years, 1.37% (4) patients experienced lead migration requiring revision. (Neuromodulation: Technology at the Neural Interface)

Neurostimulation Company Executive Questions Patent Infringement Proposed Bill

Feb. 11, 2014 - The CEO of Autonomic Technologies, Inc. and a patent attorney write in an opinion piece that proposed anti-patent-infringement legislation is unnecessarily too broad and could harm companies that assemble goods with components sourced from many manufacturers. The article describes the benefits of the startup company's ATI Neurostimulation System, a small implant designed to halt headache. (San Jose Mercury News)

Health Column Examines Study of Transcranial Stimulation to Improve Math

Feb. 11, 2014 - A column in the Wall Street Journal looks at research at Oxford University into whether noninvasive transcranial electrical stimulation can help improve performance in math. (Wall Street Journal)

Researcher Presents Studies Into Depression and Neuromodulation in Ireland

Feb. 11, 2014 - Biomarkers are needed to screen for patients who would be most likely to respond to deep brain stimulation (DBS) for depression, according to Helen Mayberg, MD, who spoke to the Royal College of Surgeons of Ireland. Mayberg said the treatment relieves psychic suffering so patients can be re-trained to engage in life in ways they are unused to, and that their previous therapeutic interventions continue. She said about 200 people have received DBS and about 80% of those in a clinical trial based in Atlanta have a sustained response, and 63% in a clinical trial based in Toronto have a sustained response. She also discussed her collaborations on brain imaging before and after cognitive behavioral therapy, which impacts the frontal cortex primarily, while drugs primarily impact the brain stem and limbic system. (Irish Times)

Advantages of Early Screening and Implantation Documented for Diaphragm Pacing in Spine-Injury Patients

Feb. 7, 2014 - A retrospective study in the Journal of Trauma and Acute Care Surgery of 22 spinal cord-injury patients who had received neurostimulation to aid breathing through diaphragm pacing just 40 days after injury found that 72% were able to breathe independently without a respirator after an average of 10 days. All the others had delayed or partial weaning but one who was taken off life-prolonging support after entering long-term acute care. Eight patients completely recovered the ability to breathe and the neurostimulation wires were removed. The study looked at 29 patients, seven of whom not did receive an implant because laparoscopic diaphragm mapping to electronically read diaphragm nerves showed their phrenic nerves were not intact. The Diaphragm Pacing System by Synapse Biomedical, Inc., NeuRx, has FDA humanitarian device approval for spinal cord injury patients and patients with amyotrophic lateral sclerosis. It received Health Canada approval in November 2013 for patients with ventilator-dependent spinal injury, and CE Mark approval in 2007 for diaphragm dysfunction. (Medical Express)

Medical Device Companies Eyed as Leading Health Care Sector Growth

Feb. 6, 2014 - A 32% growth in neuromodulation in the last three months of 2013 for Boston Scientific Corporation and a 6% growth in Medtronic Inc.'s most recent quarter were mentioned in a column that asks if the medical device industry is the biggest player in health care. (Motley Fool)

Pennsylvania Insurer Will Cover Percutaneous Tibial Nerve Stimulation for Urinary Symptoms

Feb. 6, 2014 - Independence Blue Cross of southeastern Pennsylvania will cover percutaneous tibial nerve stimulation for treatment of overactive bladder, device maker Uroplasty, Inc. announced. The addition of 2.2 million people covered by the carrier brings to some 150 million people who are covered by private insurance or Medicare who now have access to the therapy. (Wall Street Journal)

Analyst Examines Market Penetration of Vagus Nerve Stimulation System Device Maker

Feb. 5, 2014 - Depression is called the likely biggest incremental driver for value of shares of Cyberonics, Inc., whose vagus nerve stimulation systems are FDA-approved for treatment of epilepsy and depression. (Seeking Alpha)

News Show Features Man's Success in Quieting Tourette Syndrome Tics through Deep Brain Stimulation

Feb. 5, 2014 - International Neuromodulation Society member Brian Kopell, MD was interviewed regarding a patient whose more extreme tics caused by Tourette syndrome were quieted instantly when his deep brain stimulation system was programmed in September 2013. The patient's tics had included stumbling, punching himself in the head, and uttering profanities. A news report focused on the fact that the patient and his wife can finally go for walks while holding hands. (Good Morning America)

Meta-Analysis Shows Benefits of Deep Brain Stimulation in Parkinson's Disease

Feb. 2, 2014 - An analysis of randomized controlled trials comprising almost 1,200 patients up to April 2013 indicates that deep brain stimulation for Parkinson's disease "significantly improves patients’ symptoms, functionality and quality of life," a research team writes in The Journal of Neurology. They add that although the number of studies included (6) is small, the relatively large sample size does confirm treatment efficacy. (Journal of Neurology)

Hazard Alert Issued in Australia for Some Neurostimulation Devices Regarding Potential Loss of Stimulation, Over-Stimulation or Stimulation in the Wrong Area

Feb. 4, 2014 - In consultation with the Australian Department of Health's Therapeutic Goods Administraton, Medtronic Australasia has issued a hazard alert and recall for product correction concerning deep brain stimulation (DBS) and spinal cord stimulation (SCS) models that may pose a potential for loss of stimulation or over-stimulation or stimulation in the wrong area under certain conditions: DBS models Activa PC, Activa RC and Activa SC models 37601, 37602, 37603, 37612 (Activa SC models 37602 and 37603 are not affected by the over-stimulation or stimulation in the wrong area issue); and SCS RestoreUltra and RestoreSensor models 37712, 37714. Avoiding over-discharge is advised for reducing the likelihood of over-stimulation or stimulation in the wrong area -- patients should call 1800 688 670 if their device is over-discharged. At the next visit a software upgrade to the clinician's programmer will correct the potential loss of stimulation issue. (Australian Therapeutic Goods Administration)

Device Maker's Neuromodulation Revenue Tops 30% at the End of 2013

Feb. 4, 2014 - Boston Scientific Corporation's fourth quarter results for the three months ending Dec. 31, 2013 showed a 33% increase in the neuromodulation sector of its medical-surgerical division -- the second quarter in a row that neuromodulation revenue topped 30% -- and overall 5% operational revenue growth and 1% revenue growth on a reported basis compared to the prior year period. (Yahoo! Finance)

Medical Device Component Vendor Announces Flexible Neurostimulation Platform

Feb. 4, 2014 - Los Gatos, Calif.-based CIRTEC Medical Systems has released a development platform for neuromodulation devices, VeraSTIM, that offers 4 channels, 32 electrodes, up to 10,000 HZ frequency, remote transcutaneous charging, and multiple pulse modes (burst, ramp up, ramp down, etc.). The flexibility enables testing multiple parameters during device development. (PR Newswire)

Researcher: Preclinical Optogenetics Work in Dopamine Circuits Might Influence Other Therapies

Feb. 4, 2014 - A researcher says her optogenetics work in rats might be used to understand and possibly treat other conditions by using similar viral vectors to infuse therapeutic genes into relevant brain regions. In her research, rats sought alcohol less after low-frequency, prolonged stimulation of dopamine neurons in the ventral tegmental area led to accumulation of dopamine in the nucleus accumbens, which had been thought to play a role in regulating alcohol consumption. Conversely, inducing phasic release of dopamine with brief high-frequency stimulation did not lead to less drinking of alcohol by the rats. (State University of New York at Buffalo)

Recordings Detail Coordination of Brain Centers in Planning and Executing Gait Control

Feb. 3, 2014 - A research team that took extracellular single-unit recordings in the pedunculopontine nucleus of 10 Parkinson's disease patients during "awake" surgery for implantation of deep brain stimulators writes in Nature Neuroscience that different synchronous networks were activated during initial motor planning and actual motion, suggesting that changes in gait initiation in Parkinson's disease may result from disrupted network activity. (HealthCanal)

Parkinson's Disease Researchers See Promise in Preclinical Neurostimulation Studies

Jan. 30, 2014 - In a student newspaper interview, Duke university researchers say that dorsal column stimulation is less costly and invasive than deep brain stimulation and might be applied at an earlier stage in Parkinson's disease. Their study of long-term effects in a rat model of the disease required innovating electrode designs and surgical procedures to ensure a stable implant. The team plans to translate the neurostimulation findings soon to clinical research in patients who have Parkinson's disease. (Duke Chronicle)

Neurosurgeons Provide Access to Quality Services and Information for Parkinson's Disease Patients

Jan. 29, 2014 - International Neuromodulation Society member Gary Heit, MD, PhD, is credited with helping Kaiser Permanente in Northern California to set up an advanced deep brain stimulation (DBS) service that pinpoints brain targets using diffusion tensor imaging. One recent patient at the Redwood City, Calif.-based medical center, Darcy Blake, described having DBS that helped control her tremors from Parkinson's Disease. She has helped create online information for women with Parkinson's disease that includes an entry about a recent talk on Parkinson's Disease by INS Director-at-Large Jaimie Henderson, MD given to a support group at the Sunnyvale, Calif.-based Parkinson's Institute and Clinical Center. (Palo Alto Patch)

Dubai Becomes New Regional Base for Medical Device Firm

Jan. 29, 2014 - Medtronic has moved its regional Middle East and Africa headquarters from Beirut, Lebanon to a Dubai freezone-based complex, the DuBiotech Research Park, citing its "infrastructure, accessibility, and strategic location." (Mass Device)

Patients Start Receiving Commercial Implants of Recently Approved Visual Prosthetic

Jan. 29, 2014 - The first commercial implants of the Argus II visual prosthetic took place at the University of Michigan's Kellogg Eye Center. The device maker, Second Sight Medical, plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete about three months of rehabilitation and training. The retinal implant, approved by the FDA in 2013, is designed to enhance vision in patients who have been progressively blinded by the condition retinitis pigmentosa. (Mass Device)

Photos Posted of Hospital's Milestone Deep Brain Stimulation Procedure

Jan. 27, 2014 - A business newspaper printed a photo montage from Monday's 500th deep brain stimulation surgery at Allegheny General Hospital involving a patient with cervical dystonia. (Pittsburgh Business Times)

Studies Suggest Astrocytes' Role in Lingering Impact of Deep Brain Stimulation on Brain Circuits

Jan. 24, 2014 - A review summarizes how deep brain stimulation (DBS) may both inhibit neurons and activate axons, while also triggering cellular and molecular changes in other cells, especially astrocytes. Astrocytes apparently contribute to synaptic plasticity through potentiating or mediating long-term effects; in addition, DBS may increase activity in astrocytes of delta-opioid receptor to confer neuroprotection. (CNS Neuroscience & Therapeutics)

Executive Appointed to Help Guide Commercialization Efforts for External Trigeminal Nerve Stimulation Start-Up

Jan. 27, 2014 - NeuroSigma, Inc., a Los Angeles, Calif.-based company commercializing noninvasive trigeminal nerve stimulation for neurologic and neuropsychiatric disorders, has appointed a former marketing executive from Allergan, Inc., Gregory F. Brooks, to be senior vice president and chief commercial officer. NeuroSigma's first product, the Monarch eTNS System, is available by prescription in the European Union and Canada. (Market Watch)

Maker of Devices for Voiding Disorder Names New Executive to Oversee Product Development

Jan. 27, 2014 - Suranjan Roychowdhury, PhD, has been appointed vice president of Research & Development and Clinical Affairs, a new position at Uroplasty, Inc. designed to guide clinical trials for their pipeline of products to treat voiding dysfunctions. As a materials scientist who has held leadership roles at several medical devices companies, he holds 20 issued U.S. patents in cardiology, orthopedics, urology and drug delivery. (Wall Street Journal)

Closed-Loop, Cortical Stimulation Proposed for Parkinson's Disease

Jan. 18, 2014 - Closed-loop cortical stimulation may offer clinical benefit for treating advanced Parkinson's disease, according to authors who review the issue, including the potential of mathematical modeling to contribute to its development. (Clinical Neurophysiology)

Voiding Dysfunction Medical Device Company Reports Quarterly Earnings

Jan. 23, 2014 - Uroplasty, Inc. reported a strong fiscal 2014 third quarter ending Dec. 31, 2013. Total revenues grew 14% over the same quarter the previous year to $6.4 million. The company forecasts 25-30% revenue growth for its Urgent PC neuromodulation system in the U.S. during the fourth quarter of fiscal 2014. Operating expenses were up, $6.3 million compared to $5.5 million the same quarter last year, reflecting investment in ongoing sales training, expansion and reorganization of the sales and marketing team and programs, and the medical device tax. The company booked a non-GAAP operating loss of $0.3 million compared with $0.1 million in the third quarter a year ago. (Market Watch)

Publication Cites Spinal Cord Stimulation's Neuroprotective Effects in an Animal Model of Parkinson's Disease

Jan. 23, 2014 - A study in rats indicates that repeated spinal cord stimulation may have a neuroprotective effect that could slow progression of Parkinson's disease. In the animals, six weeks of twice-weekly treatment led to such improved symptoms of depleted dopamine as better motor skills and a reversal of significant weight loss. The treated rats had better neuron survival and a higher density of dopaminergic innervation in brain regions controlled movement. (Duke University)

Landing Science Conferences Such As the INS 13th World Congress in 2017 is Considered a Coup for an Expanded Convention Center in Edinburgh

Jan. 22, 2014 - The International Neuromodulation Society's World Congress in 2017 is mentioned as one of three science conferences from 2015 - 2017 that are considered coups for the Edinburgh, Scotland International Conference Centre whose expansion opened in May. The state-of-the-art facilities and popular and natural draw of the city were cited by an executive for the British Neuroscience Association. In 2015 its Festival of Neuroscience will coincide with the Edinburgh International Science Festival. The International Congress and Convention Association rates the Edinburgh just behind London as a U.K. conference destination and 33rd worldwide. (Edinburgh News)

Neuromodulation Devices Count Heavily in Publications' Top-Ranked New Medical Technologies

Jan. 22, 2014 - Three of Fierce Medical Devices' list of the top eight FDA medical technology approvals in 2013 are neuromodulation devices -- Second Sight's Argus II Retinal Prosthesis System, NeuroPace's antiepilepsy neurostimulation implant, and eNeura's antimigraine device. (Fierce Medical Devices)

Small Piezoelectric Power Supplies are Under Development for Medical Devices

Jan. 21, 2014 - Research in large animals, published in the Proceedings of the National Academy of Sciences, shows that piezoelectric nanoribbons of lead zirconate titanate implanted on the surface of the heart, lungs and diaphragm can generate up to eight volts of electricity under mechanical stress. The prototype device stores the electrical current in a small battery, and the senior author says the device was able to power a few off-the-shelf pacemakers. An industry observer commented that in five years, such an approach to harvesting mechanical energy of the body, for instance, in arm or leg muscles or organs that move, may drive biosensors and biodevices. (Popular Mechanics)

External Trigeminal Nerve Stimulation Studies in Epilepsy Presented

Jan. 21, 2014 - Positive results in adjunctive treatment for epilepsy using external trigeminal nerve stimulation were announced last month by NeuroSigma, Inc. at the annual American Epilepsy Society meeting. The presentations concerned 10 patients who had reduction in seizures of 30 - 50% or more after 12 weeks and 8 of whom chose to continue treatment beyond the initial 18 weeks; as well as a Phase II sub-analysis of 26 patients who experienced a mean seizure reduction of 34.4% compared to an increase of 6.6% in the control group. Patients in the sub-analysis group met inclusion criteria of having 4 - 60 seizures per month -- the same criteria as will be used in an upcoming, recently approved pivotal trial. (PR Newswire)

Review Summarizes Published Studies of Tibial Nerve Stimulation in Fecal Incontinence

Jan. 21, 2014 - International Neuromodulation Society member Charles Knowles, MBBChir, PhD and co-authors reviewed 12 published clinical studies of tibial nerve stimulation to control fecal incontinence. In a randomized controlled study and case series reports, percutaneous tibial nerve stimulation (PTNS) resulted in a weekly reduction of at least 50% in occurrences of fecal incontinence in 63-82% of patients; transcutaneous tibial nerve stimulation (TTNS) resulted in similar success in 0-45% of patients. In a randomized controlled trial of PTNS vs. TTNS vs. sham, treatment success was 82% with PTNS, 45% with TTNS, and 13% in sham. (British Journal of Surgery)

Company Seeks CE Mark for Spinal Cord Stimulation System

Jan. 20, 2014 - After filing for pre-market approval of its spinal cord stimulation system last month, Greatbatch filed a CE Mark application for the system with the German notified body TÜV SÜD America. (Mass Device)

A Medical Technology Assessment Board is Formed in India

Jan. 20, 2014 - India is setting up a Medical Technology Assessment Board to evaluate appropriateness and cost-effectiveness of available and new health technologies in the country. The board will operate within the Department of Health Research, which signed a memorandum of understanding with the National Institute of Clinical Evidence (NICE) to exchange information about regulatory procedures. Although a Parlimentary panel has asked for a timeframe for the board to become functional, the government does plan to consult like technology generators, industry, regulators, economists, user groups and experts knowledgeable about similar models from UK, Canada, Australia, Thailand etc. (Pharmabiz.com)

Percutaneous Tibial Nerve Stimulation for Bladder Symptoms Most Effective When a Sensory Response is Present in Patients with Multiple Sclerosis

Jan. 20, 2014 - A study of percutaneous tibial nerve stimulation in 83 patients with multiple sclerosis and lower urinary tract symptoms indicated that despite the effects of the disease on neuronal pathways, the most frequently observed perception of bladder condition was a sensory response, with or without a motor response, and this was associated with a more successful therapy outcome than motor response alone. (Multiple Sclerosis Research)

Cardiologist Considers Hypoglossal Nerve Stimulation for Sleep Apnea Potentially Helpful for Heart Health

Jan. 15, 2014 - Future studies of hypoglossal nerve stimulation for obstructive sleep apnea should evaluate cardiovascular outcomes, a cardiologist says in a column discussing the promising study published in the New England Journal of Medicine about the therapy. The author writes that obstructive sleep apnea worsens outcomes in heart disease, and treating the sleep disorder may help to prevent heart disease. (Everyday Health)

Health Economy Model Predicts Nerve Stimulation for Refractory Hypertension is Cost-Effective

Jan. 10, 2014 - Compared to optimal medical management, therapeutic electrical stimulation of the carotid baroreceptors in patients who have medication-resistant hypertension is projected to add 2.17 quality-adjusted life years (QALY), according to a health-economic modeling analysis published in the Journal of Hypertension. Its incremental cost-effectiveness ratio is 7,797 euros per QUALY gained in a European payer setting, well below the recognized threshold of 35,000 euros. CVRx Inc. announced the findings concerning its Barostim device. The second-generation Barostim neo is commercially available in Europe and the therapy is also subject to a pivotal clinical trial in the U.S. (Diagnostic and Interventional Cardiology)

Chief Medical Officer Will Oversee Development of Sphenopalatine Ganglion Stimulation for Chronic Headache

Jan. 20, 2014 - Autonomic Technologies, Inc. has appointed as chief medical officer Shashidhar Kori, MD. With a background in establishing and running large academic training programs in pain management, he was previously vice president of Clinical Development and Medical Affairs at Allergan and MAP Pharmaceuticals, and senior director of Clinical Development and senior medical advisor on the pain/migraine team at GlaxoSmithKline before that. He will oversee clinical trials of the ATI™ Neurostimulation System for cluster headache and migraine in the United States and in Europe. (Business Wire)

Neurology Researchers Develop Mobile Application to Facilitate Quicker Programming of Deep Brain Stimulation Systems

Jan. 16, 2014 - An iPad-based clinical decision support system in preliminary testing reduced the time to program deep brain stimulation systems more than 99% (less than two minutes, rather than four hours). The project at the Medical College of Wisconsin has received a $25,000 grant from the Clinical and Translational Science Institute of Southeast Wisconsin for a prospective randomized study in Parkinson's disease patients at Froedtert Hospital. (Medical College of Wisconsin)

Study Examines Optimal Deep Brain Stimulation Approaches to Control Essential Tremor

January 2014 - By quantifying performance of seven patients with essential tremor in a reaching task, research authors determined an optimal deep brain stimulation target -- usually in the posterior subthalamic area, beneath the inferior border of the thalamic nucleus ventralis intermedius -- and pulse strength and duration to suppress tremors and limit the induction of ataxia. (Brain)

Neurostimulation Devices Called a Technology to Watch

Jan. 14, 2014 - Many recent developments have borne out a prediction from 2010 that technological advancements would improve neurostimulation device efficacy and potential to disrupt the market, according to a "technologies to watch" news report. The report also mentions neuroprosthetic development and sensors. (Medical Device and Diagnostic Industry)

New Insight Into Opioid Receptor Function May Aid Development of Pain and Mood Interventions

Jan. 14, 2014 - The doorway to treating pain and mood disorders through interfacing with opioid receptors may have widened with discovery of the architecture of a sodium channel that seems common to all three types of opioid receptors. As reported in Nature, the work was achieved by crystalizing the receptors and visualizing their structure through X-ray crystallography. (Medical News Today)

Randomized Prospective Clinical Study Favorably Compares Sacral Neuromodulation to Standard Medical Treatment

Jan. 10, 2014 - Sacral neuromodulation to manage mild symptoms of overactive bladder is superior to standard medical treatment in controlling symptoms and contributing to better quality of life, according to a six-month prospective, randomized, multicenter clinical trial. The study was sponsored by the InterStim® Therapy device maker, Medtronic, Inc. (Neurourology and Urodynamics)

TV Pain Documentary Introduces Spinal Cord Stimulation for Neuropathic Pain

Jan. 10, 2014 - Spinal cord stimulation is described as a non-drug approach to controlling back pain in a Discovery Channel documentary, "Pain Matters." (Newsmax Health)

Article Discusses Activity of Deep Brain Stimulation in Motor Disorder

January 2014 - Recent animal and human evidence strongly suggests that antidromic activation from the subthalamic nucleus desynchronizes motor cortex activity. The implications for the pathogenesis and treatment of Parkinson's disease are discussed. (JAMA Neurology)

Expert Panel on Occipital Nerve Stimulation for Medically Refractory Primary Headache Starts Today for INS Members

Jan. 13, 2014 - The International Neuromodulation Society is hosting an Expert Panel for members on occipital nerve stimulation for medically refractory primary headache, co-moderated from Jan. 13 - 27 by specialists who have published groundbreaking studies about the technique since its inception -- Prof. Peter Goadsby, MD, PhD, director of the Headache Center at the University of California, San Francisco; and Richard L. Weiner, MD, clinical associate professor of neurosurgery at the University of Texas Southwestern Medical Center and Chairman of Neurosurgery at THR Presbyterian Hospital of Dallas. (International Neuromodulation Society)

Gene Therapy Dosing Trial in Parkinson's Patients

Jan 10, 2014 - In a dosing trial involving 15 patients with advanced Parkinson's disease, researchers have injected a gene-therapy vector bilaterally into the patients' putamen to produce dopamine there. Patients who received the highest dosages had to reduce their intake of levodopa. In a publication in Lancet, the researchers report that motor scores improved at 6 and 12 months, and the therapeutic, ProSavin, was safe and well-tolerated with mild to moderate side-effects. Kyriacos Mitrophanous, head of research at Oxford BioMedica in England, the company that developed the therapy and funded the study, said he thinks the treatment will eventually outperform deep brain stimulation or levodopa. (Imperial College London)

Small-town Neuromodulation Center Has Big Plans

Jan. 9, 2014 - The Greenville Neuromodulation Center is offering distance learning to clinicians about deep brain stimulation and has opened a facility on the main street of its small hometown north of Pittsburgh, PA to bring together patients, their families, and visiting healthcare professionals, as well as facilities for treatment, diagnosis and recovery, and training and research. In addition, the center has established a teaching relationship with neuroscience students at the local Thiel College. (Keystone Edge)

Study: Neurostimulation Device for Sleep Apnea Reduced Symptoms 70%

Jan. 9, 2014 - An office-based low-magnetic-field stimulation approach to relieving depression, accidentally discovered when bipolar patients were receiving MRIs 12 years ago, has become the first to be selected for a 90-day proof-of-concept trial under the NIH's Rapidly Acting Treatments for Treatment Resistant Depression program, according to the company, Tal Medical of Boston. Tal (Hindi for rhythm) believes the oscillating magnetic field of the MRI was resetting the brain's rhythm while being too low to trigger neuron firing. The company is being incubated by PureTech Ventures of Boston. (Fierce Medical Devices)

Magnetic Field Treatment Approach to Depression Will Enter a Fast-Tracked Proof-of-Concept Trial

Jan. 8, 2014 - Medtronic, Inc.'s spinout Inspire Medical Systems of Maple Grove, MN reported in the New England Journal of Medicine a prospective study of 126 patients with obstructive sleep apnea in whom symptoms of interrupted breathing at night dropped some 70% within a year of being implanted with a hypoglossal nerve stimulator. The company is scheduled to present the device for FDA review next month. The implant was studied in patients who had trouble accepting or adhering to the current standard treatment, a sleep mask called a continuous positive airway pressure device, or CPAP. (MedPage Today)

Migraine Therapy Device Maker Receives $2.2 Million Investment

Jan. 6, 2014 - Sunnyvale, Calif.-based eNeura Therapeutics received a $2.2 million investment in late December in an equity transaction with an unnamed investor, on the heels of FDA clearance for its Cerena transcranial magnetic stimulator for migraine relief. The device is designed to be held to the back of the head to stimulate the occipital cortex when a patient senses a pre-migraine aura. (Mass Device)

Optogenetics Study Pinpoints Activity of a Brain Center in a Rat Model of Alcoholism

Jan. 3, 2014 - A low and prolonged level of dopamine release accomplished through optogenetics stopped rats from binging or consuming alcohol, and the cessation continued even after stimulation ended, according to a university press release about experiments reported in Frontiers in Behavioral Neuroscience. The stimulation centered on a region that was known to be activated through alcoholic behavior, the ventral tegmental area. Its role had not been clear. The study indicated that tonic, but not phasic, stimulation led to attenuated alcohol consumption by the rats. (State University of New York, Buffalo)

Medicare Recipients are Under-Represented Among Parkinson's Disease Patients Receiving Deep Brain Stimulation

Jan. 3, 2014 - An analysis of more than 665,000 Medicare recipients between 2007-2009 by collaborators at the University of Pennsylvania and Washington University in St. Louis found that patients with Parkinson's disease from lower socioeconomic strata are less likely to receive deep brain stimulation (DBS) for motor symptoms. The study, published in Neurology, states that out-of-pocket costs for DBS are 41% higher than non-DBS care, so low-income seniors may be less willing to pay the approximately $2,200 per year, and referring and treating physicians may be less likely to consider the treatment. (Medical Xpress)

 

Last Updated on Thursday, October 23, 2014 11:40 AM
 
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