2011 News Briefs - International Neuromodulation Society

Later News:

Migraines Relieved by Peripheral Nerve Stimulation

December 27, 2011 - A patient of neurosurgeon Alexander Green, a member of the INS' Neuromodulation Society of the United Kingdom and Ireland, was profiled in the U.K. Daily Mail about finding relief from her weekly migraines after becoming the approximately 200th patient in the U.K. to receive a peripheral nerve stimulation implant. (Daily Mail)

First U.S. Use of AdaptiveStim with RestoreSensor Reported

December 23, 2011 - St. Mary's Pain Relief Center in Huntington reported that it conducted the first U.S. surgery to use a neurostimulation device that automatically adjusts with the movement of the patient. (WOWKTV.com)

Review of 45 Cases of Epilepsy Treated with Vagus Nerve Stimulation

December 21, 2011 - Drs. B. Min et al. reviewed 45 cases of drug-resistant epilepsy treated with vagus nerve stimulation (VNS). The review showed VNS to be a safe and effective treatment, with an overall response rate of 64% among adults and children. The analysis suggests duration of VNS therapy may be a crucial factor on prognosis. (Chinese Medical Journal)

International Team Investigates Preclinical Models of Stimulating Walking Solely through the Spinal Cord

Research through a CRDF grant to the Pavlov Institute of St. Petersburg and the Department of Integrated Biology and Physiology of the University of California, Los Angeles' School of Medicine indicates walking can be initiated and stimulated exclusively in the spinal cord. The grant-making organization reports the collaborators, with Dr. Susan Harkema at the University of Louisville, have recently shown marked recovery of motor and autonomic functions in individuals that have been completely paralyzed for more than two years. (CRDF Global)

VNS surgery for epileptic children is reported to show long-term cost savings

December 20, 2011 - In a study of 30-month outcomes in 445 young Medicaid patients, vagus nerve stimulation surgery had nearly paid for itself within a year, and began to save taxpayers money soon afterward, Dr. Sandra Helmers reported at the annual meeting of the American Epilepsy Society. (Clinical Psychiatry News)

Deep-brain Stimulation is among New Depression Therapies Examined in Lancet Seminar

December 19, 2011 - University of Pittsburgh authors of a Lancet seminar that reviews advances in depression treatment report that deep-brain stimulation appears potentially promising. (Los Angeles Times)

2011 Consensus Panel Issues New Guidelines for Intrathecal Pain Management

December 19, 2011 - The 2011 Polyanalgesic Consensus Conference has updated the 2007 guidelines used to determine treatment via intrathecal administration for patients suffering from severe chronic pain, recommending Ziconotide as first-line treatment for nociceptive and neuropathic chronic pain. (PR Newswire)

Deep Brain Stimulation for Epilepsy Highlighted in Popular Press

December 18, 2011 - The Big Think, rated Time Magazine's top news site in 2011, presents a brief overview of deep brain stimulation for epilepsy, with a link to a Dec. 17, 2011 article in the UK's Daily Mail about the first epileptic in Europe to receive the treatment. (The Big Think)

NANS Announces Achievement Awards

December 16, 2011 - Becker's Orthopedic, Spine & Pain Management Review reports awards received at the North American Neuromodulation Meeting by Dr. Elliot Krames for lifetime achievement, and Dr. K. Dean Willis for distinguished service. Both have served in many leadership roles, and Krames is past president of the International Neuromodulation Society. (Becker's Orthopedic, Spine & Pain Management Review)

Analysis of Pediatric Patients in Argentina Shows VNS Benefit in Refractory Epilepsy

December 14, 2011 - An analysis of 64 pediatric patients who were treated with vagal nerve stimulation (VNS) for epilepsy has been published in the medical journal Epileptic Disorders: international epilepsy journal with videotape. Examining the use of the NeuroCybernetic Prosthesis system from Cyberonics, the authors, based at the Buenos Aires Pediatric Hospital Neurology Department, saw an early positive clinical result, with efficacy progressing with duration of treatment. VNS was well-tolerated, and in a significant number of patients, was associated with reduced seizure severity, shorter recovery time, and shorter hospital stays. The authors, Drs. R.O. Cersósimo, M. Bartuluchi, S. Fortinit, A. Sorau, H. Pomata, and R.H. Caraballo, conclude VNS is effective and well-tolerated in children with refractory epilepsies, and improves quality of life. (PubMed)

Spinal Cord Stimulation for Paralysis Receives New-Technology Award

December 13, 2001 - A new treatment that restores some voluntary movement in spinal cord injury patients by applying electrical stimulation directly onto the spinal cord has received the 2011 Popular Mechanics Breakthrough Award. The award named UCLA researchers Yury Gerasimenko and V. Reggie Edgerton, CalTech bioengineer Joel Burdick, and Susan Harkema, Rehabilitation Director at the Kentucky Spinal Cord Injury Research Center, as well as Rob Summers, a 25-year-old paraplegic who was the first patient to undergo the treatment. (AMS Vans)

Database Analysis Examines Costs of Intrathecal Pump Use

December 14, 2011 - Hospitalization appears to be the major expense associated with the use of intrathecal pumps, according to a poster presented by Pentec Health at the North American Neuromodulation Society annual meeting in Las Vegas. The study analyzed claims from nearly 40,000 adults from 2005- 2011. (PRWeb)

Small Study Suggests Magnetic Stimulation May Benefit Patients Experiencing Post-Stroke Neglect

December 14, 2011 - Treating stroke patients who have lost control and awareness of one side of their body with magnetic stimulation to the brain may improve their symptoms, according to a small, two-arm trial of 18 patients reported in the journal Neurology. Lead author Dr. Giacomo Koch, from the Santa Lucia Foundation in Rome, said that larger studies at multiple treatment sites are needed to determine how helpful magnetic stimulation can be in stroke recovery. (Reuters)

Spinal Modulation's Neurostimulator Receives CE Mark in Europe

December 12, 2011 - The Spinal Modulation Neurostimulator system has received CE mark for the management of chronic intractable pain through low-level electrical stimulation of primary sensory neurons located within the dorsal root ganglion, which is implicated in chronic pain. The CE mark clears the way for marketing in Europe; the system is not approved at this time for use or sale in the United States. (Spinal News International)

Retinal Implant Technologies Advance in Europe, U.S.

December 12, 2011 - Scientific American presents a round-up of experimental treatments for retinitis pigmentosa that are undergoing clinical trials or reaching the market. (Scientific American)

Australian Therapeutic Goods Administration Approves Components of EnteroMedics' Weight Loss Spinal Cord Stimulation System

December 13, 2011 - EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity, metabolic disease and other gastrointestinal disorders, announced approval by the Australian Therapeutic Goods Administration of the critical active implantable medical device components of the Maestro(R) System, a first-in-class weight loss treatment designed to control both hunger and fullness by blocking the primary nerve which regulates the digestive system.

Study Provides Potential Explanation for Mechanisms of Associative Memory

December 13, 2011 - Researchers from the University of Bristol report in the Journal of Neuroscience they have discovered that a chemical compound in the brain can weaken the synaptic connections between neurons in a region of the brain that is important for the formation of long-term memories. The findings may provide a potential explanation for loss of memory associated with Alzheimer's. (Medicalxpress.com)

Definitive Deal Announced for Acquisition of Surgical-Instrument Maker Codman & Shurtleff

December 12, 2011 - The surgical instruments business of Johnson & Johnson subsidiary Codman & Shurtleff is being acquired by orthopedic company Symmetry Medical in a $165 million deal expected to close before January 2012. The new business segment will be called Symmetry Surgical, and operate out of Nashville, Tenn. (MassDevice)

Investigators Present Initial Long-Term Results of Multicenter Prospective Clinical Trial to Address Chronic Pain Through Stimulation of the Dorsal Root Ganglion

December 11, 2011 - Dr. Liong Liem and Dr. Paul Verrills presented initial results of the world's first multicenter prospective clinical trial to assess the management of chronic pain through stimulation of the dorsal root ganglion, to mask or interrupt signals before they enter the spinal cord, on December 11, 2011 in Las Vegas during the Annual NANS Conference. (BusinessWire)

Direct Electrical Stimulation the Brain — the Gold Standard for Mapping Brain Functions?

December 11, 2011 - A perspective piece asserts that direct electrical stimulation may not be the gold standard in mapping brain functions, stating that its effect "is difficult to predict as it depends on many local and remote physiological and morphological factors", and ranges from evocation to inhibition of responses — sometimes even when applied at the same cortical site. (Nature Reviews Neuroscience)

Integrated Research Device Combines Optical Neuromodulation and Electrical Recording for Chronic in Vivo Applications

December 11, 2011 - Brown University Prof. Jing Wang and colleagues describe a device that can monitor neural network activity for months in animal models that may prove useful for studying conditions such as epilepsy. (Journal of Neural Engineering)

Medtronic: Data Show Neurostimulation System Provides Effective Pain Relief and Convenience for Patients with Chronic Back/Leg Pain

December 9, 2011 - Medtronic unveiled clinical data in support of its recently cleared AdaptiveStim pain management implant with RestoreSensor at the North American Neuromodulation Society last week. The system was recently approved by the FDA and uses motion sensing to adapt stimulation levels to manage chronic pain. (Medtronic)

Current Neuromodulation Concepts Discussed

December 8, 2011 - North American Neuromodulation Society board member Dr. David Caraway discussed advances in neurostimulation technology in a pre-meeting news feature, as well as mentioning that some studies show it can be beneficial in the treatment of diseases and conditions such as urinary incontinence, depression, movement disorders, seizure disorders, Parkinson's and some gastrointestinal issues. (Becker's Orthopedic, Spine & Pain Management Review)

Cortical Activation Changes underlying Stimulation-Induced Behaviorial Gains in Chronic Stroke

December 6, 2011 - In research published in an open-access abstract from the journal Brain, Charlotte Jane Stagg, associate faculty member at the University of Oxford, and colleagues show for the first time that the significant behaviorial improvements produced by anodal stimulation to the ipsilesional hemisphere are associated with a functionally relevant increase in activity within the ipsilesional primary motor cortex in patients with a wide range of disabilities following stroke. (Brain

Sorin Group Plans Neurostimulation Studies for Congestive Heart Failure in 2012

December 5, 2011 – The Italian medical technology company Sorin Group has invested $7 million in Enopace Biomedical to develop its implantable neurostimulator. The device increases heart efficiency by reducing workload placed on the left ventricle. (MassDevice)

Fund Provides Neuroscience Pilot Grants at University of Minnesota

December 5, 2011 – The University of Minnesota has established $500,000 in annual support for neuroscience research through the Wallin Discovery Fund. The first round of awards are supporting four projects, including one examining the effect of deep brain stimulation on addiction. (Star Tribune)

Improving Patient Experience with Spinal Cord Stimulation: Implications of Position-Related Changes in Neurostimulation

December 2, 2011 - Doctors David Abejon and Edgar Ross report that a new type of spinal cord stimulation system that incorporates accelerometer technology to automatically adjust stimulation amplitude based on patient position may better meet patient analgesic needs and is in early clinical application. (Neuromodulation, via PubMed)

Smart Deep Brain Stimulation Could Reduce Parkinson’s Symptoms through Neural Monitoring

December 2, 2011 – Researchers in Milan have reported developing a smart deep brain stimulation device for Parkinson’s that monitors neuron activity and determines exactly where electrical impulses are needed before delivering them, which should help reduce symptoms. (UPI.com)

Urology Researcher Sees Tibial Stimulation Potentially Opening Neurostimulation to the Masses

December 1, 2011 - Dr. Philip Hanno, professor of urology at the University of Philadelphia, interviews Dr. Kenneth Peters, an industry consultant and chair of urology at Beaumont Hospital in Royal Oak, MI about the increasing role of neurostimulation in treating bladder conditions, pain disorders, erectile dysfunction, and other urologic needs. Dr. Peters maintains a prospective patient database, and says neurostimulation can be cost-effective and help patients who don't improve with other therapies, and really impacts quality of life when offered frequently and early. (ModernMedicine)

Neuromodulation Global Market Reaches an Estimated $3 billion in 2011

November 30, 2011 – Neuromodulation is one of the fastest-growing medical device market sectors. The market research report “Neuromodulation Devices: World Market Prospects 2011-2021” by Visiongain pegs the global value in 2011 at $3 billion. (PR Web)

FDA: Acute Residual Limb Pain in Amputees Can be Treated with Neuros Medical’s Electrical Nerve Block

November 29, 2011 - Neuros Medical, Inc. has received Investigational Device Exemption (IDE) approval from the FDA for its high-frequency Electrical Nerve Block technology for use in acute treatment of residual limb pain in amputees. The implanted system has a pacemaker-like stimulus generator, lead wires, and a cuff electrode. It is designed for applications such as neuroma/residual limb pain, chronic post-surgical pain, and chronic migraine. (Medgadget)

Sapiens Receives Development Funding for High-Resolution Probe for Deep Brain Stimulation

November 29, 2011 – Sapiens Steering Brain Stimulation announced a €3.5 million Strategic Translation Award from the Wellcome Trust to support development of next-generation deep-brain stimulation technology. Sapeins is developing a high-resolution probe for treating patients with Parkinson’s disease and other degenerative brain disorders. An additional €6.5 million in funding has been received from the Michael J. Fox Foundation and Agentschap NL. (Wellcome Trust)

BBC Reports on University of Toronto Results Showing Hippocampus Growth with Deep-Brain Stimulation of Alzheimer's Patients

November 27, 2011 - The BBC reports that University of Toronto researchers who showed growth in the brain's "memory hub" following a year of deep-brain stimulation in two of six Alzheimer's patients  will be planning to enroll 50 patients with mild disease in a 2-arm study in the spring. Of the previous patients tested, it was the ones with milder disease who showed the promising hippocampus growth, of 5 - 8%. (BBC)

Pilots Improve Learning with Direct Current Stimulation, U.S. Air Force Finds

November 25, 2011 – Transcranial Direct Current Stimulation boosts learning, Air Force researchers reported. Pilots being trained to guide unmanned attack drones learned more quickly and sustained the learning with this mild electrical stimulation to the brain. The results were presented at the Society for Neuroscience annual meeting. (Scientific American)

Hypoglossal Nerve Stimulation Shows Promise for Increasing Airflow with Obstructive Sleep Apnea

November 25,2011 - In a study published in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine, Alan R. Schwartz, MD, and colleagues at the Johns Hopkins Sleep Disorders Center, reported positive results from their use of Apnex's hypoglossal stimulator to treat obstructive sleep apnea. "In our study, acute unilateral stimulation of the hypoglossal nerve during sleep in patients with obstructive sleep apnea resulted in progressive increases in inspiratory airflow with increasing stimulation intensity, and inspiratory flow limitation was completely eliminated in the majority of patients," said Dr. Schwartz. (EurekAlert).

Deep Brain Stimulation Shown to Reverse Damage of Alzheimer's Disease in Small Study

November 23, 2011 - At the Society for Neuroscience Annual Meeting last week, Dr. Andres Lozano and colleagues from Toronto Western Hospital, reported the findings of a six-patient, year-long study of deep brain stimulation for the treatment of Alzheimer's Disease. In all six patients, after one year of stimulation, the reduced use of glucose by the temporal lobe and posterior circulate was reversed and, in the two of the patients whose hippocampuses grew in size, and there was better than expected cognitive function. (New Scientist)

INS Leaders are Featured in Daily Mail Article about the Use of Spinal Cord Stimulation for the Treatment of Chronic Sciatic Pain

November 22, 2011 - Dr. Simon Thomson, President of the International Neuromodulation Society, and Dr. Sam Eldabe, President-Elect of the Neuromodulation Society of the UK and Ireland, are interviewed in a story describing the positive outcome of spinal cord stimulation in a patient who had previously suffered for years from chronic sciatic pain. (UK Daily Mail)

Team Tailors Functional Electrical Stimulation by Adjusting Ion Concentrations

November 21, 2011 – A plastic surgery research team from Harvard University’s Beth Israel Deaconess Medical Center and engineers from MIT are creating a low-current functional electrical stimulation device designed to decrease side effects by manipulating the concentration of charged particles around the nerve. Unwanted muscle contractions and stimulation of nearby sensory nerves could be minimized with the concept, demonstrated in frogs and reported in Nature Materials. (Beth Israel Deaconess Medical Center)

New Study Reaffirms Benefit of Deep Brain Stimulation for the Treatment of Severe Depression

November 18, 2011 - A multi-center pilot study sponsored by St. Jude Medical, Inc., has shown that stimulation of Brodmann Area 25 improved depression symptoms and quality of life in patients suffering  from severe, refractory depression. This reaffirms outcomes of a previous study by Drs. Andres Lozano and Helen Mayberg that was published in Neuron in 2005. Conducted at three centers in Canada, the study showed 62 percent of the patients in the study had a 40 percent reduction in symptoms, as compared to their baselines. The full study results were published in the Journal of Neurosurgery. (MarketWatch)

Neurostimulator with Motor Sensor Approved by the FDA

November 17, 2011 - The AdaptiveStim™ with RestoreSenstor™ neurostimulation system from Medtronic, Inc., has received FDA approval for the treatment of chronic pain. Utilizing motion-sensor technology found in smart phones and computer gaming systems,  the device automatically adapts stimulation levels according to postural changes and subsequent fluctuations in the patient's stimulation requirements. This obviates the need for the user to make manual adjustments. (MedCity News)

Study Shows Brain Stimulator Effective in Reducing Seizures from Medically Refractory Epilepsy

November 8, 2011 - A recent study published in Neurology, reports the outcome of a 191-patients study, in which 97 patients were treated with NeuroPace Responsive Neurostimulation (RNS) System, while the remainder were in a placebo group. Of the 97 patients who received the neurostimulation, 37.9 percent experienced fewer seizures than prior to the therapy. (Newswise)

INS Supports European Year of the Brain 2014

October 28, 2011 - As part of its public education campaign, the International Neuromodulation Society (INS) is joining over 190 organizations to support the European Brain Council's (EBC) proposal for the European Commission to recognize 2014 as The European Year of the Brain (EYOB). We invite  you to read more and join us in supporting this important initiative that could influence the future of brain neuromodulation in Europe

Obstructive Sleep Apnea Therapy Receives European Approval

October 26, 2011 - Apnex Medical, Inc., has received CE Mark approval in Europe to market and sell its neurostimulation device for the treatment of obstructive sleep apnea. The company presently is pursuing FDA clearance for the device. (Star Tribune)

New Therapy Targeting Post-Stroke Shoulder Pain Shows Promise

October 26, 2011 - As part of a multi-center clinical study, a medical team from the Carolinas Medical Center has implanted SPR Therapeutics' Micropulse® peripheral,intramuscular nerve stimulator for the first time in a patient to treat shoulder pain associated with hemiplegia. The group has reported promising results from the first implant.
(MedCity News)

Researchers Develop Electrode Coating That Influences Local Concentration of Ions

October 26, 2011 - A team from Harvard Medical School and the Massachusetts Institute of Technology are researching a calcium ionophore coating on implanted electrodes in frogs, that can either absorb or release calcium ions, depending on the direction of the current across the electrode. As a potential enhancement to existing electrodes, this membrane could help reduce the amount of current strength needed to stimulate nerves by modulating local calcium ions. (Royal Society of Chemistry)

Study on External Trigeminal Nerve Stimulation for the Treatment of Pediatric ADHD Announced

October 24, 2011 - In collaboration with the University of California Los Angeles, NeuroSigma, Inc., will launch its clinical trial on non-invasive, external trigeminal nerve stimulation to treat attention deficit hyperactivity disorder in children. The device interface consists of an adhesive, conductive pad that is affixed to the patient's forehead and stimulates the branches of the trigeminal nerve. (MarketWatch)

Enopace Biomedical Receives Funding for Neuromodulation Therapy to Treat Patients with Congestive Heart Failure

October 20, 2011 - Sorin Group has invested $7 million in Enopace Biomedical for the development and study of an implantable neurostimulator to increase heart efficiency in patients suffering congestive heart failure. (Mass Device)

National Institute of Neurological Disorders and Stroke (NINDS) Funds Research on Floating Light Activated Micro-electrical Stimulators

October 17, 2011 - NINDS has provided a grant to researchers at Boston University to fund research on FLAMES, Floating Light Activated Micro-electrical Stimulators, for the "wireless activation of the central nervous system." The patient-controlled, external device would beam infrared light through an optical fiber outside the dura matter, to activate the implanted device to stimulate the desired neuron with electrical current. The device has not yet entered clinical trials. (R & D Magazine)

Trial on Transdermal Neuromodulation for Urge Incontinence and Overactive Bladder Commences

October 14, 2011 - EMKinetics, Inc., is launching the pivotal trail of its TranStim™ transdermal, posterior tibial nerve stimulator for the treatment of urinary urge incontinence and overactive bladder. Upon completion of the study, the company will apply  for CE Mark and FDA approval. (PR Newswire)

Penta™ Surgical Lead Receives Regulatory Approval in Japan

October 7, 2011 - The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted regulatory approval of St. Jude Medical's Penta™ surgical Lead for neurostimulation for the treatment of chronic pain. The Penta lead is also available in the U.S., Europe, Australia and Canada. (MassDevice)

Researchers at Northwestern University Report that Three-Quarters of Medical Device Makers First Seek Regulatory Approval Outside of the U.S.

October 6, 2011 - The study, funded by the Institute for Health Technology Studies, citied that the FDA's lengthy and complicated 501(k) review process as well as the associated costs has led device companies to seek approval overseas before applying for FDA approval. (Mass Device)

Small Clinical Trial Shows Promising Results for Treating Alzheimer's Disease with  Transcranial Magnetic Stimulation

October 6, 2011 - Initial results of Brainsway's 24-patient clinical trial on the use of deep transcranial magnetic stimulation therapy for Alzheimer's disease suggest that the "high frequency treatment leads to improvement of Alzheimer's disease assessment scales." (MedGadget)

Cyberonics Invests in ImThera's Neurostimulator for Obstructive Sleep Apnea

October 5, 2011 - Cyberonics, which produces a vagus nerve stimulator for epilepsy, has invested $4 million to fund research on  ImThera's hypoglossal nerve stimulator for the treatment of obstructive sleep apnea. ImThera is pursuing CE Mark approval in Europe and plans are underway for a pivotal clinical trial. (Xconomy)

Transcranial Magnetic Stimulator (TMS) Receives Approval from Israeli Ministry of Health Approval for the Treatment of Intractable Psychiatric Disorders

October 4, 2011  - The Israeli Ministry of Health has granted approval of Brainsway Ltd.'s TMS for the treatment of neurological and psychopathological disorders, including intractable depression, bipolar disorder and schizophrenia-related cognitive impairment. In April, the device received CE Mark approval in Europe for the treatment of Parkinson’s disease, and as an add-on treatment to antidepressants for major depression. (Mass Device)

Clinical Trial of Chronic Vagus Nerve Stimulation for Heart Failure Commences

September 30, 2011 - Boston Scientific has launched its NECTAR-HF clinical trial on 96 patients at multiple centers in Europe, to assess preliminary efficacy and safety of its vagus nerve stimulation system for treating heart failure. The study will evaluate if the therapy can improve heart function and slow the progression of the heart failure. (Mass Device)

Diaphragm Pacing System that Assists Breathing in Some ALS Patients Receives FDA Approval

September 29, 2011 - Synapse Biomedical has received Humanitarian Device Exemption (HDE) from the FDA for its NeuRx Diaphragm Pacing System, which electrically stimulates the diaphragm to contract, thus assisting patients with inadequate breathing to breathe. The 106-patient clinical trial demonstrated that the repeated stimulation strengthens the diaphragm muscles to help delay respiratory failure.

Nevromatrix Receives $3.5M in Funding to Further Research on its Neurostimulator

September 27, 2011 - Everett Partners has invested $3.5 million in Nevromatrix in support of further research on its Auto-Targeting Neurostimulation therapy, a device designed to non-invasively pinpoint the source of pain. Nevromatrix obtained FDA approval for the device last year. (Globes)

New Research on Deep Brain Stimulation Studies the Subthalamic Nucleaus' (STN) Role in Making Tough Decisions

September 26, 2011 - A recent study published in Nature Neuroscience examines the regions of the brain involved in making difficult decisions and determined that when the prefrontal cortex requires time for deliberation, it engages the STN to halt impulsive urges from the striatum. In patients undergoing deep brain stimulation of the STN for Parkinson's disease, the STN was not engaged in this decision making process, thus allowing the patients to make  impulsive and less accurate decisions. These findings have suggested that brain regions communicate by low frequency signals and that if DBS could be refined to avoid or not affect this frequency range, it would not impair the STN's role in the decision-making process. (ScienceDaily)

Researchers to Launch Clinical Trial on Repetitive Transcranial Magnetic Stimulation (rTMS) for Refractory Epilepsy

September 23, 2011 - With support from the Epilepsy Therapy Project and the Epilepsy Foundation, researchers at Children’s Hospital Boston’s epilepsy program soon will begin a clinical trail on patients with refractory temporal lobe epilepsy to study the effects of rTMS therapy. (MassDevice)

New Scientific Study Shows That DBS May Help Improve Spatial Memory

September 22, 2011 - An animal study published in The Journal of Neuroscience, found that electrical stimulation of the entorhinal cortex in adult mice led to a two-fold increase in new cells in the hippocampus. The cells that were generated during the one hour of stimulation seemed to be functional, showing normal development and connection with adjacent brain cells. (Science Daily)

Anulex Technologies, Inc, Receives FDA Approval of its Spinal Cord Stimulation Lead Anchors

September 20, 2011 - The FDA has given clearance to Anulex Technologies' fiXate™ Tissue Band, which secures Spinal Cord Stimulation (SCS) lead anchors to the fascia or interspinous/supraspinous ligament in patients with chronic, intractable pain in the limbs and/or trunk. (Enhanced Online News)

Neurotech Reports Publishes Highlights from the International Neuromodulation Society's Pre-Conference on Neuromodulation Innovations and Bringing New Ideas to Market

St. Jude Medical Receives European Regulatory Approval for its Neurostimulator to Treat Intractable Chronic Migraine

September 7, 2011 - St. Jude Medical has received European CE Mark approval for its Genesis™ neurostimulator for peripheral nerve stimulation of the occipital nerves for the treatment of intractable chronic migraine. "The CE Mark approval was supported by the results of St. Jude Medical’s chronic migraine study, a randomized, double-blind, controlled study that collected data from 157 patients…" and "demonstrated that participants in the active group showed a 41% improvement after 12 weeks of stimulation, compared to a 13% improvement in the control group."(BusinessWire)

NeuroSigma Receives STTR Phase I Grant from NINDS to Further Research on eTNS Therapy for Intractable Epilepsy

September 6, 2011 - National Institute of Neurological Disorders and Stroke (NINDS) has awarded NeuroSigma an NIH Small Business Technology Transfer (STTR) Phase I Grant to further development of its external trigeminal nerve stimulator (eTNS™) for the treatment of intractable epilepsy. The grant will be applied toward the animal and human clinical trials of a new pulse generator and electrodes. (NewsMedical)

SynchroMed II Pump Model 8637 is Recalled Over Battery Defect

August 30, 2011 - Medtronic's SynchroMed II™, model 8637, implantable pump has been recalled due to a problem that has caused some batteries to abruptly cease working. The FDA has approved a  modification to the battery, designed to prevent the problem from occurring in pumps with the new battery; all Synchromed II pumps are being manufactured with the new battery. Updated 9/1/11 (Mass Device)

Aleva Neurotherapeutics Receives EUR 9.5 Million in Series A Financing

August 26, 2011 - Aleva Neurotherapeutics will apply the funding toward the development of its "intelligent electrode," which is compatible with current deep brain stimulators, as well as a device for cortical stimulation. This "target-specific stimulation has been developed to significantly reduce the side effects and potential complications as well as the costs of DBS therapy." (Science Business)

CVRx Receives European CE Mark Approval for its Electrical Stimulator to Treat Hypertension

August 25, 2011 - CVRx has received CE Mark Approval for its Barostim neo, which treats uncontrolled hypertension by electrically stimulating the baroreceptors on the carotid artery. The stimulation causes the artery to relax and increase bloodflow, thereby enabling the heart to slow down and fill with more blood. Subsequently, the kidneys eliminate more fluid from the body, thus lowering excessive blood pressure. (MedCity News)

New Study Shows Promise for Treating Refractory Fibromyalgia with Vagus Nerve Stimulation

August 24, 2011 -  A preliminary study published in Pain Medicine, reports that vagus nerve stimulation may be effective for treatment-resistant fibromyalgia. At the three-month mark, five of the 11 patients studied experienced improvement in pain, overall wellness, and physical function. (About.com)

NINDS Grants MicroTransponder $2.5 Million to Continue Development of its Neurostimulator

August 16, 2011 - The National Institutes of Neurological Disorders and Stroke (NINDS) has awarded a Phase II U44 SBIR grant of $2.5 million to MicroTransponder to further develop its SAINT™ wireless neurostimulator for the treatment of chronic pain and other neurological disorders, after the company  successfully reached its Phase I endpoints. MicroTransponder has collaborated with the NINDS staff to "develop milestones designed to efficiently translate this technology for clinical use." (PRWeb)

Sacral Nerve Stimulator Shows Promise for Treating Fecal Incontinence at Three-Year Follow-Up

August 15, 2011 - The Journal Diseases of the Colon and Rectum has published a study on Medtronic's InterStim sacral nerve stimulator, showing that the therapy reduced episodes of fecal incontinence by at least 50% in 86% of the 77 individuals studied. The number of episodes per week decreased from a mean of 9.4 per week to 1.7 per week. Forty percent of the patients experienced complete continence. (medGadget)

Cyberonics Stops Shipment of Aspire Generators (Models 105 and 106)

August 15, 2011 - Cyberonics, Inc., has stopped shipping and is recalling field  inventory of its Aspire generators (models 105 and 106) due to a hardware-related design issue. The company does not believe the generator will put patients at risk, but it is suspending its E-36 clinical trial until inconsistencies in the output current have been resolved. (Street Insider)

Neuromodulation: Technology at the Neural Interface is now indexed in MEDLINE / PubMed!

August 12, 2011 - The journal of the International Neuromodulation Society, Neuromodulation: Technology at the Neural Interface, has been reviewed by the National Library of Medicine and accepted for indexing in MEDLINE / PubMed! Please be aware that it will take a few weeks for the content to be loaded onto the MEDLINE database. As of now, the listing will begin with Volume 14, Number 1; please be assured that we are working to ensure that all previous content will be listed as well.

New Study Shows STN-DBS is Effective in Treating the Symptoms of Parkinson's Disease for at Least 10 Years

August 8, 2011 - A study published in the Archives of Neurology followed 18 people who were implanted with STN-DBS in the mid- to late 1990s. The researchers assessed the study participants' motor skills, daily tasks and behavior at one, five and ten years, with stimulation and without, and determined that the subjects performed "significantly better overall when stimulated at each time point, even after 10 years."  (Nature.com - Spoonful of Medicine)

Apnex Medical Receives FDA Approval for Its Obstructive Sleep Apnea Clinical Trial

August 3, 2011 - Apnex Medical will initiate the clinical trial with 132 patients in 15 medical centers in the United States and five other sites in Australia and Europe. Sensing respiration, the implanted device electrically stimulates the hypoglossal nerve, making the tongue to move toward the front of the mouth. (MedCity News)

Study Shows Transcranial Direct Current Stimulation Can Improve Brain Function in Schizophrenics

July 29, 2011 - Researchers at the Neuroscience Research Australia (NeuRA) used an external transcranial direct current stimulator to stimulate the pre-frontal cortex of people with schizophrenia for 20 minutes. The results suggested that the stimulation improved learning abilities in those who demonstrated a propensity for learning prior to the stimulation. (Science Alert)

Three Companies Developing Neuromodulation Devices to Treat Obstructive Sleep Apnea

July 27, 2011 - Apnex Medical, IMThera, Inspire Medical Systems, are developing implantable neurostimulators for the treatment of moderate to severe obstructive  sleep apnea. Both Apnex's and Inspire's systems sense respiration and deliver mild stimulation to the largest muscle of the tongue, while IMThera's technology does not sense respiration, but stimulates multiple muscles of the tongue. (MedCity News)

Nevro Corp. Secures $58 Million to Fund U.S. Pivotal Trial and International Commercialization of Spinal Cord Stimulator to Treat Chronic Pain

July 19, 2011 - Johnson and Johnson Development Corporation, as well as Nevro's existing investors, Aberdare Ventures, Accuitive Medical Ventures, Bay City Capital, Mayo Clinic, MPM Capital, and Three Arch Partners have invested in Nevro's neurostimulator for the treatment of chronic back and leg pain. (Mass Device)

U.S. Institute of Medicine's (IOM) Report on Chronic Pain Holds Promise for Neuromodulation Therapy Research and Patient Access

July 14, 2011 - Mandated by President Obama’s healthcare reform law, the IOM's report stressed the importance of improving research and treatment of chronic pain, providing "a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America.” Xconomy Boston followed-up with a commentary, explaining how the report may also aid research and development in the medical device industry. (IOM Report, Xconomy Boston)

New Transdermal Stimulator Launched To Treat Chemotherapy-Related Nausea and Vomiting

July 13, 2011 -  At the 2011 Scientific Meeting of the American Society of Clinical Oncology (ASCO), Neurowave Medical Technologies presented positive clinical results on a new transcutaneous electrical nerve stimulator  being used to reduce nausea and vomiting associated with chemotherapy.  The Nometex device stimulates the median nerve on the underside of the wrist and modulate gastric rhythm via neural pathways and vagus nerve. (Reuters)

Medtronic Receives Clearance for Blood Pressure Study

July 11, 2011 - Medtronic has received FDA approval of the design of a clinical study to treat hypertension using focused low-power radio frequency applied through the Simplicity Catheter System to the renal arteries near the kidneys. The study will be conducted in 60 centers across the U.S. and will include 500 patients. (Star Tribune)

St. Jude Medical Receives Approval for Expansion of its Study on DBS for Severe Depression

July 11, 2011 - The FDA has given St. Jude Medical clearance to expand its clinical study, which will be conducted at 20 medical centers across the U.S. and will include 125 patients suffering from severe depression. Outside the U.S., similar studies already are underway. (Med City News)

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Last Updated on Wednesday, September 12, 2018 06:15 PM