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News Briefs from the International Neuromodulation Society |
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Industry News Feed
Neuromodulation Growth Reported in Company Earnings ReportApril 25, 2013 - Boston Scientific announced global year-over-year revenue growth of 6 percent in neuromodulation and combined revenue in the countries of Brazil, Russia, India and China 35 percent year-over-year, while taking a write down of $422 million related to the 2006 acquisition of Guidant Corp. for $28 billion. Overall adjusted earnings per share were $0.16 for the first quarter ended March 31, 2013, on revenue of $1.761 billion. (Sacramento Bee)
April 2013 - Neurotech Reports, the publisher of Neurotech Business Report, will publish the 2013 Directory of Neuromodulation Products later this year. The print directory will be given to each attendee at the 11th World Congress of the International Neuromodulation Society (INS), which takes place June 8-13, in Berlin, Germany, and attracts more than 1,500 clinicians, engineers, researchers and entrepreneurs to hear an internationally renowned faculty address the most comprehensive breadth of all neuromodulation therapies. For more information, contact Neurotech Reports at 415 546 1259 or visit this link: http://www.neurotechreports.com/pages/2013_Directory_Neuromodulation_Products.html (Neurotech Reports)
April 19, 2013 - The International Neuromodulation has accepted a record number of abstracts for its 11th World Congress June 8 - 13 in Berlin. Diverse highlights are previewed in a news announcement issued today. INS also announced a pre-conference innovation-and-investment summit. (Newswise) Company Plans Presentation on External Trigeminal Nerve Stimulation in Children with ADHDApril 18, 2013 - Results of external trigeminal nerve stimulation in children aged 7 - 14 who have attention deficit hyperactivity disorder will be presented on May 20 in San Francisco by Los Angeles-based NeuroSigma, Inc. The open-label Phase I study was prompted by observations in PET scans of the stimulation's effect on attention centers. (San Francisco Business Times) Report Foresees Double-Digit Growth in NeuromodulationApril 18, 2013 - TechNavio predicts a compound annual growth rate of 15.3 percent from 2012 - 2016 for neuromodulation across the globe, partly due to an increase in neurological disease. (PR Web)
Company Sees First-Quarter Earnings Dip, But Strong Year-Ahead ProspectsApril 17, 2013 - St. Jude Medical sales of neuromodulation products were $99 million in the first quarter of 2013, down 4 percent from the prior year. Overall, partly due to unfavorable currency translations, the company reported net sales of $1.338 billion in the first quarter of 2013, a decline of approximately 4 percent compared with the first quarter of 2012. With more than 20 diverse products due to launch in 2013, the company expects full-year 2013 consolidated net earnings to be in the range of $3.68 to $3.73. (Wall Street Journal) Deep Brain Stimulation Service Comes to BangaloreApril 17, 2013 - Commenting on a new deep brain stimulation service for Parkinson's disease patients in Bangalore, a neurologist calls the procedure a good option in carefully selected patients. The Columbia Asia Referral Hospital in Yeshwanthpur is one of more than 20 medical facilities in India and Southeast Asia operated by Columbia Asia Group, which entered the country with 100 percent foreign investment. (Moneylife)
Company to Launch Anchoring Technology for Spinal Cord Stimulation Leads and Pain Pump Catheters April 15, 2013 - Boston Scientific Corporation announced it has acquired and is launching the Fixate Tissue Band for spinal cord stimulator leads and pain pump catheters. Anulex Technologies of Minnetonka, MN developed the device to secure leads to the fascia or inter-spinous/supra-spinous ligament, and received expanded FDA approval last year for the catheter application. International Neuromodulation Society member Richard Bowman, MD, commented that the device permits quick and efficient lead anchoring. (Implantable Medical Devices)
A Limited U.S. Launch of Spinal Cord Stimulation System with Three-Dimensional Software Control April 12, 2013 - Boston Scientific Corporation announced a limited U.S. launch of its Precision Spectra spinal cord stimulation device, which received FDA approval following CE Mark approval. International Neuromodulation Society past president Giancarlo Barolat, M.D., medical director of Barolat Neuroscience in Denver, called the device "a paradigm shift". It uses a proprietary computer model, Illumina 3D, to guide control of the stimulation field based on 3D anatomy and the conductivity of the spinal cord and surrounding tissue. (Yahoo Finance)
Peripheral Nerve Stimulation Trial for Back Pain Begins Enrolling PatientsApril 11, 2013 - Patient enrollment has begun in the SubQStim II pivotal clinical trial of peripheral nerve stimulation for chronic back pain. Medtronic, Inc. plans for up to 323 patients at up to 30 U.S. centers in the trial, in which patients will be randomized into control or treatment groups for the first three months, then participate in open-label follow-up for up to five years. (Mass Device)
Company Announces Research Funding, Prize to Develop "Electroceuticals"April 10, 2013 - The global pharmaceutical company GlaxoSmithKline (GSK) announced plans to foster development of "electroceuticals" that were compared to a cross between a device and molecular medicine. The investment might initially target using an electric stimulus to regulate cytokine production involved in inflammatory diseases such as rheumatoid arthritis. The unveiling includes a $1 million research prize, and initial funding of work by 40 scientists in 20 labs at such institutions as MIT, the University of Pennsylvania, and Feinstein Institute of Medical Research. Heading the effort, GSK Vice President of Bioelectronics Research and Development Kristoffer Famm was lead co-author of a commentary in Nature. (Fierce Biotech)
Future Growth Will be a Key Topic of the INS 11th World Congress Pre-Conference, Innovations in NeuromodulationApril 10, 2013 - The International Neuromodulation Society expects more than 200 entrepreneurs, thought leaders, innovators and investors at Innovations in Neuromodulation on June 9th in Berlin, a pre-conference of the INS 11th World Congress. The day-long session draws industry strategists and investment managers by focusing on business, technical, and regulatory developments in this rapidly changing field. (BusinessWire) Regulatory Agency Issues First Approval for Deep Brain Stimulation for Both Primary and Secondary DystoniaApril 10, 2013 - St. Jude Medical, Inc. announced it is the first to receive CE Mark approval for use of deep brain stimulation to manage both primary and secondary dystonia. Dystonia is considered secondary when its cause can be attributed to a toxin, injury, or another disease or condition. In the announcement, International Neuromodulation Society Member Elena Moro, Ph.D., professor of neurology at the University Hospital Center of Grenoble, France noted that the involuntary muscle contraction and spasms of dystonia strike people of all ages. (St. Jude Medical)
Spinal Cord Stimulation Featured in Business Column March 29, 2013 - International Neuromodulation Society member Anthony Berg, MD, was interviewed by a business columnist about using the new 32-contact Precision Spectra spinal cord stimulator by Boston Scientific. In the three cases he has implanted so far, patients have all seen a significant drop in use of pain medication and an improvement in quality of life, he said. (Dallas Business Journal)
Neuromodulation Market Report Offers Forecast to 2017March 25, 2013 - Research and Markets calls neuromodulation a high-growth industry for the next decade, and offers the report "Neuromodulation Market - [Spinal Cord Stimulation (SCS), Vagus Nerve Stimulation (VNS), Gastric Electrical Stimulation (GES), Deep Brain Stimulation (DBS), Sacral Nerve Stimulation (SNS), & Transcranial Magnetic Stimulation (TMS)] - Forecasts to 2017". (PR Newswire)
Maker of High-Frequency Stimulation Device Garners $48 Million in Series C FinancingMarch 7, 2013 - Nevro Corp. has completed a $48 million Series C round of financing led by new investor Novo Ventures, with New Enterprise Associates and Coviden Ventures. Existing investors participating in this financing round included Accuitive Medical Ventures, Bay City Capital, Johnson & Johnson Development Corporation, Mayo Clinic, MPM Capital, and Three Arch Partners. Based in Menlo Park, Calif., Nevro is commercializing the Senza® high-frequency spinal cord stimulation system for chronic pain, such as low back pain, and other conditions. The system is available in Europe and Australia. The funds will be used to sponsor an ongoing U.S. clinical trial, explore new indications, and support commercialization. (Nevro)
Heart Failure Neuromodulation Developer Receives Additional Startup FundingFeb. 28, 2013 - Sorin Group announced a $5 million investment in Israel-based Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure. Sorin Group, a global medical device company based in Milan, has invested in Enopace in 2011 and anticipates further investments based upon completion of development milestones. (BusinessWire)
Feb. 26, 2013 - Greatbatch, Inc. posted a fourth-quarter 2012 adjusted earnings per share of 53 cents significantly exceeded the year-ago adjusted earnings of 39 cents (up 36% year over year). Within the neuromodulation and cardiac rhythm management area, sales decreased 5% year over year to $73.7 million due to market competition, strong shipments in the prior quarter and tough year-over-year comparables. In this sector, management anticipated short-term headwinds from key original equipment manufacturer customers. (NASDAQ.com)
Deep Brain Stimulation Developer Receives Additional FundingFeb. 25, 2013 - Sapiens Steering Brain Stimulation B.V. of Eindhoven, the Netherlands and Munich, Germany, has added €7.5 m to its €16.5 m round of Series A financing. The investment supports development of a deep brain stimulation with the capacity to steer the electrical pulses away from areas which may produce side-effects. The most recent financing comes from the Dutch investment group INKEF Capital, whose founder Frank R. Landsberger, PhD, was appointed to the company's advisory board. Sapiens was spun out in 2011 from Royal Philips Electronics to commercialize a steering brain stimulation probe, implant and image-guided programming. (News-Medical.Net)
Vagus Nerve Stimulation Device Company Sees Shares ClimbFeb. 22, 2013 - Cyberonics Inc. said Friday that its net income climbed 39 percent in the fiscal third quarter as it sold more of its nerve stimulation devices designed to treat epilepsy and depression by delivering electrical stimulation to the vagus nerve. Net income in the November-January quarter rose to $13.2 million, or 47 cents per share, from $9.5 million, or 34 cents per share. Revenue rose grew 15 percent, to $62.7 million from $54.5 million. (CNBC) Agreement Reached to Distribute Neuromodulation Products in JapanFeb. 20, 2013 - The Boston Scientific subsidiary Boston Scientific Japan K.K. has reached an agreement with Fukuda Denshi Co., Ltd. to market and sell the Boston Scientific Spinal Cord Precision Plus System and accessories throughout Japan. Fukuda Denshi will begin distributing Boston Scientific neuromodulation products April 1, 2013. (Boston Scientific)
Clinic Created to Streamline Process for Potential Deep Brain Stimulation CandidatesFeb. 20, 2013 - A new clinic aimed at streamlining the evaluation and approval process for the growing number of patients who are potential candidates for deep brain stimulation has opened at the Muhammad Ali Parkinson Center of the Barrow Neurological Institute. The process should now be completed in six weeks or less, rather than up to one year, and includes comprehensive treatment education. (PR Newswire)
New Rates for INS Pre-Conference SessionsFebruary 2013 - The pre-conference sessions on June 8 and 9 for the 11th World Congress, Technology Transforming Chronic Illness Management, are now $360.53 each day, or $600 for both days. Register for one or two pre-conference days and the main congress and receive a 10% discount on the pre-conference fee. (International Neuromodulation Society) Brazilian Chapter of the International Neuromodulation Society Launches WebsiteFebruary 2013 - The Brazilian chapter of the INS (Sociedade Brasileira Neuromodulação - SBNM) has published its website listing articles, conferences, and members and their specialties, which include interventional pain treatment, movement disorders, spasticity, and neurosurgery.
Australia, Colombia Approve Non-Invasive Vagus Nerve Stimulation for Primary HeadacheFeb. 19, 2013 - New Jersey-based ElectroCore announced approval from Australia and Colombia for its non-invasive vagus nerve stimulation (nVNS) therapies for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache and hemicrania continua) and medication-overuse headache in adults. The GammaCore therapy is available in Australia with physician authorization, and is expected to be available in Colombia in the first half of 2013. (MarketWatch)
A Social Media Presence for the 11th World Congress Feb. 1, 2013 - The International Neuromodulation Society has added an 11th World Congress "event" area to its Facebook page about the June 2013 meeting in Berlin that features a map of the meeting location at the Estrel Hotel, and provides an opportunity to share information, post a photo, video, or link, and network with upcoming attendees. (Facebook)
Magnetic Resonance Imaging Compatible Spinal Cord Stimulation Systems Released in EuropeJan. 30, 2013 - Medtronic, Inc. released in Europe the first spinal cord stimulation systems for use in treating chronic back and/or leg pain that are designed for compatibility with full-body magnetic resonance imaging (MRI) scans under specific conditions. The devices recently received CE Mark approval. They include special leads that can withstand MRI scanning and a proprietary programming option, SureScan, which sets an appropriate mode for an MRI environment. International Neuromodulation Society member J.P. Van Buyten, MD, from the AZ Niklaas Hospital in Belgium, was quoted as calling the development an important advancement. (National Pain Report)
Retinal Implant Maker Eyes Raising More Capital Jan. 29, 2013 - Second Sight Medical of Sylmar, Calif. registered with the Securities and Exchange Commission on Monday to raise $25 million while waiting for the FDA to decide whether to approve its retinal implant, Argus II, which has been sold in Europe since 2011. (MassDevice)
Chronic Pain is Called a Poorly Recognized Silent EpidemicJan. 29, 2013 - International Neuromodulation Society president Simon Thomson, MBBS, FRCA, FIPP, FFPMRCA, commented in conjunction with release of a survey of more than 1,000 chronic pain sufferers across Europe, " The Painful Truth Survey: The State of Pain Management in Europe," sponsored by Boston Scientific and supported by a number of regional pain associations. He noted that healthcare systems throughout the world have not really produced specific answers to the needs of patients who suffer chronic pain that is not resolved by addressing any identifiable underlying condition. Some 17% of Europeans, he continued, will have significant chronic pain affecting daily living, with about 1/3 of those having pain that is really quite severe. About half suffer from neuropathic pain that arises spontaneously from damage to the nervous system. Of the patients whose neuropathic pain does not respond to pharmacological treatment, he said, spinal cord stimulation becomes an option, and has been advancing technologically since he first began using it slightly more than 20 years ago. (Boston Scientific) Global Randomized Clinical Trial to Compare Medical Management With Or Without Spinal Cord Stimulation for Lower Back PainJan. 28, 2013 - International Neuromodulation Society member Philippe Rigoard, M.D., is principal investigator of a global randomized clinical trial of patients with predominant low back pain due to failed back surgery syndrome. The study, sponsored by Medtronic, Inc., compares optimal medical management combined with use of a multicolumn, implantable lead for neurostimulation treatment and optimal medical management alone. The first of up to 300 patients in the PROMISE trial began treatment in the U.S. earlier this month, and Dr. Rigoard started enrolling patients January 14 at Poitiers University Hospital in France. The study is designed to assess the value of spinal cord stimulation (SCS) for predominant low back pain with leg pain. Previous studies focused on predominant leg pain. Health care utilization data will be collected to develop cost analysis models to potentially evaluate the long-term economic impact of SCS. (Yahoo Finance)
Neuromodulation Startup Adds Board Member
Jan. 22, 2013 - Functional Neuromodulation, founded in Toronto in 2010, has added Vince Owens, former CEO and director of Intelect Medical, to its board of directors. Other board members are company co-founder and CEO Dan O’Connell; founding scientist Andres Lozano, MD, PhD; Kelly Holman, managing director of Genesys Capital; and Andrew D. Firlik, MD, managing partner at Foundation Medical Partners. Lothar Krinke, PhD, vice president and general manager of Medtronic’s Deep Brain Stimulation business serves as an active board observer. Dedicated to applying deep brain stimulation (DBS) to memory and other cognitive disorders, the company is conducting the ADvance Study in North America to evaluate DBS of the fornix, a major pathway in the brain’s memory circuit, for patients with mild Alzheimer’s disease. (BioSpace)
Small-Business Grant Announced to Aid Deep Brain Stimulation System Programming for Parkinson's Disease Jan. 22, 2013 - The National Institutes of Health, National Institute of Neurological Disorders and Stroke is funding a clinical feasibility study at the University of Alabama at Birmingham through a $283,828 Phase I Small Business Innovation Research grant to Cleveland, OH-based Great Lakes NeuroTechnologies to explore using intelligent algorithms to aid programming deep brain stimulation in Parkinson’s disease. The system will leverage existing technology to quantify Parkinson’s motor symptoms such as tremor, bradykinesia, and dyskinesia into a functional map. Intelligent algorithms will determine optimal parameters for symptom relief while minimizing side effects and battery consumption. (News-Medical.Net)
Functional Neuromodulation System for Foot Drop Cleared for Use by Minors Jan. 22, 2013 - Valencia, Calif.-based Bioness Inc. announced it has received FDA clearance to market to pediatric patients and their caregivers its L300 system to treat foot drop, a condition which causes walking difficulty in adults and children who have motor-impairment conditions such as cerebral palsy, stroke or traumatic brain injury. The system consists of a small wireless sensor in the shoe, a sport brace-like leg cuff worn just below the knee, and a hand-held remote control. In addition to being used to assist walking, it can also be used for rehabilitation purposes. (Business Wire)
Israel-Based Company Eyes an Expanded Presence in U.S. Trading and DistributionJan. 21, 2013 - Brainsway Inc. of Israel expects to name a U.S. partner this quarter to distribute its noninvasive transcranial magnetic stimulation system for treatment-resistant depression, a technology it licensed from the National Institutes of Health. This step would precede seeking listing on the Nasdaq exchange, according to an article in Bloomberg BusinessWeek. (Bloomberg)
Jan. 14, 2013 - The U.S.-based firm Marketsandmarkets forecasts the global neuromodulation market will reach $6.8 billion by 2017. Vagus nerve stimulation is expected to see the most growth due to being less invasive and with more development of applications anticipated. The key factors that drive the neuromodulation market are higher incidences of endemic diseases, rise in aging population, technological advancement, devices under approval, and presence of several niche players. Reimbursement in certain geographies and cost of devices are major challenges. North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China. (PR Newswire)
New Device Rules Reported to Take Effect This Month in Russia Jan. 11, 2013 - Revised regulations regarding medical device clearances in Russia reportedly took effect Jan. 1, 2013. It was previously reported that some of the anticipated changes were that final approval decisions will be made by “expert reviewers” rather than the regulator (Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation, or Roszdravnadzor); there was an apparent lack of timelines for medical testing, meaning they could last for years; and medical device registration fees would be written into law. One anticipated change could mean expert reviewers would determine whether additional clinical testing of a device is necessary and provide a list of hospitals where that should occur. A registration certificate would be issued to an applicant based on a positive expert review, or a refusal would be based on a negative expert review. (Mass Device)
Jan. 9, 2013 - Brainsway Ltd. announced it has obtained FDA approval for its deep transcranial magnetic stimulation device to treat depression in patients who fail to respond to therapeutics during a depression cycle. (Globes)
Neuromodulation, Emerging Markets, May Contribute to Device-Maker's Bottom LineJan. 8, 2013 - Medtronic expects stronger performance in areas like neuromodulation to lift overall corporate growth. In comments Monday at the J.P. Morgan Healthcare Conference, Chief Executive Omar Ishrak also said that the countries outside of China, such as India in particular, but also Central Europe, Middle East and Africa, Latin America, all would be expected to be big growth engines. (Fox Business)
Smart Phone Interface Technology Presented for Controlling TENSJan. 9, 2013 - The Consumer Electronics Show included what was presented as a certified transcutaneous electrical nerve stimulation medical product by China-based E-Tek that uses an iPhone interface, according to a blog covering the event. (9to5Mac) External Peripheral Nerve Stimulator to Initially Target Post-Stroke Shoulder PainJan. 8, 2013 - SPR Therapeutics expects CE mark certification for its Smartpatch peripheral nerve stimulator to be announced shortly, according to published comments by the chief executive officer of the Cleveland-based company. Also, the company plans clinical trials at six U.S. centers in the next few months, initially targeting post-stroke shoulder pain. Finally, the company was reported to have raised an additional $2.8 million in financing, bringing the total to $5 million from NDI Healthcare Fund, Public Square Partners and individual investors. (MedCity News) Market Study Projects Neuromodulation Growth to $12.45 billion by 2023Jan. 8, 2013 - London-based Visiongain predicts a $12.45 billion global market for neuromodulation devices by 2023, with sales of $3.03 billion in 2011. Hemant Mistry, healthcare industry analyst, says, "The neuromodulation device market has experienced substantial growth in recent years, as their benefits in cost saving particularly have become more evident. Such devices can not only provide long-term relief to patients, but can also offer an effective alternative to the use of drugs that are well-known to have side effects . . . (although the initial cost of the device and surgery to implant the device is high, their prescription is cost-effective in the long-term). With future developments in the pipeline such as phrenic nerve and gastric stimulators . . . the market for neuromodulation devices has significant potential to grow in the future". (PR Newswire)
Upcoming Neuromodulation Market Report Predicts Continued GrowthJan. 3, 2013 - The growth in emerging markets such as India and China will be driven by an aging population that will increase demand for newer treatment options for age-related diseases, such as deep brain stimulation (DBS) for motor disorders, according to a market report being published next month by Visiongain. The report, for instance, anticipates the DBS market will almost double in value, reaching $0.85 billion in 2017, with a compound annual growth rate of 11.2%. (Visiongain)
Company's Device Reaches 100,000th ImplantDec. 24, 2012 - Cyberonics, Inc. announced the 100,000th patient implant of its vagus nerve stimulation (VNS) system for epilepsy. This is the 15th year of VNS approval for the treatment of epilepsy in the U.S. and 25th anniversary of Cyberonics' founding. (NASDAQ)
Neuromodulation Market Report ReleasedDec. 5, 2012 - Reportlinker.com announced a new analysis of global neurostimulation markets from 2010 - 2018. The report analyses markets for spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electric stimulation; and profiles 21 companies, including Boston Scientific Corp., Cyberonics, Inc., Medtronic, Inc., St. Jude Medical, Inc., Synapse Biomedical, Inc., and SPR Therapeutics, LLC. (The Street)
Nov. 30, 2012 - Cyberonics, Inc. maintained an "outperform" rating by Zacks Equity Research due to strong continued growth in its vagus nerve stimulation products to treat epilepsy in the U.S. and abroad. The last-reported quarter saw a 17% increase in sales to $63 million compared to the same quarter last year, and an increase in earnings per share of 37.5% to 44 cents. The results surpassed Zacks consensus estimates of $60 million in sales and 39 cents in earnings per share. (Zacks Equity Research)
Patent Issues for Method to Treat Obesity Through Sympathetic Nerve StimulationNov. 27, 2012 - The U.S. Patent Office issued a patent Nov. 27, 2012 assigned to Advanced Neuromodulation Systems, Inc. (now part of St. Jude Medical) for treating obesity by electrically stimulating the sympathetic nervous system to induce feelings of satiety and increase energy expenditure. Stimulation would be applied on or near sympathetic nerves such as the sympathetic chain ganglia, the splanchnic nerves (greater, lesser, least), or the peripheral ganglia (e.g., celiac, mesenteric). (Equities.com)
Insurance Coverage for Overactive Bladder Neurostimulation Treatment ExpandsNov. 27, 2012 - More than 4 million insureds in California and Florida now have coverage for posterior tibial nerve stimulation (PTNS) for the treatment of overactive bladder, the device company Uroplasty, Inc. announced. In addition, Medicare administrators for 13 states have extended coverage from 1 to 2 years based on recent data showing sustained benefit from continued PTNS therapy. (Market Watch)
Nov. 6, 2012 - A U.S. patent issued Nov. 6, 2012 and assigned to Medtronic, Inc. covers an implantable lead with coplanar contract coupling to reduce conductor bending moments where the contact connects to the lead, reducing chances of stress affecting the conductor that can interfere with reliability of the connection. (NewsRx.com) Patent Issued to Limit Patient-Initiated NeurostimulationNov. 6, 2012 - A U.S. patent issued Nov. 6, 2012 and assigned to Cyberonics, Inc. would provide the capability to set a variety of limits or alternative modes, which may include reduced repeat on-demand dosing, on patient-initiated stimulation doses for an implantable neurostimulator, such as a vagus nerve stimulator used to treat epilepsy. (equities.com)
Company Acquires Vagus Nerve Stimulation Developer to Enhance Heart Failure PortfolioNov. 12, 2012 - Milan-based Sorin Group announced acquisition of Neurotech SA, of Belgium, which developed an implantable vagus nerve stimulator that uses a rechargeable battery and records neural activity of the target. Sorin said the acquisition will accelerate the time to market of its neuromodulation therapies to treat heart failure. Neurotech SA was spun out of the Université catholique de Louvain with funding by SOPARTEC, the technology transfer company of Université catholique de Louvain, Vives Louvain Technology Fund SA and SRIW Techno SA (Société Régionale d'Investissement de Wallonie). (Business Wire)
Neuromodulation Market Predicted to Grow to More Than $7 billion by 2018Oct. 30, 2012 - The market for neuromodulation devices is expected to grow at a compound annual growth rate of 14.4 percent from 2012, reaching $7.07 billion in 2018, according to a report by Transparency Market Research. North America accounted for 65% of the market in 2011, while the Asia-Pacific region represents the fastest growth at a compound annual growth rate of 14%. Contributing to that growth is the aging population, coupled with the increase in chronic diseases, increasing demand for minimally invasive surgeries, and availability of external funding to conduct clinical studies to help come up with new and technologically advanced products. (PR Newswire)
Cleveland-Based Firm Receives Most Promising Startup AwardOct. 29, 2012 - Cleveland-based Neuros Medical, Inc. received Neurotech Reports' 2012 Gold Electrode Award for Most Promising Startup at the Neurotech Leaders Forum in San Francisco on Oct. 22. Publisher James Cavuoto said the company has a strong, focused market and is executing development of its technology in a sound and effective manner. The company is carrying out a pilot clinical trial to evaluate its patented high-frequency Electrical Nerve Block™ technology for acute treatment of pain in the residual limb of amputees. The company has also identified potential applications in chronic post-surgical pain, chronic migraine, and trigeminal neuralgia. (Neuros Medical)
Supplier Reports Increased Income from NeuromodulationOct. 26, 2012 - Greatbatch, Inc.'s neuromodulation and cardiac rhythm management sales increased 13% from the previous year, to $80.3 million, the company reported in a quarterly earnings statement. Overall, third-quarter adjusted earnings of 46 cents per share exceeded the year-ago adjusted earnings of 41 cents per share and were above an analyst consensus estimate of 44 cents per share. The company reported a net loss of $7.6 million, compared to a net gain in the third quarter of 2011 of $7 million. The cause of the loss was reported to come from operational hazards at its Swiss orthopedic facilities.
Low-Profile Neurostimulation Device Earns PatentOct. 25, 2012 - International Neuromodulation Society member Carl Wahlstrand and Robert Skime are inventors on a U.S. patent issued Oct. 23, 2012, and assigned to Medtronic, Inc. for a neurostimulation device with a low profile so it may be implanted directly beside a neuralgic region at the back of the neck, for instance, to relieve symptoms of occipital neuralgia. (equities.com)
Paralympic Athlete Releases Her Biography Next Week at Neurotechnology Conference Oct. 15, 2012 - Jennifer French, a quadriplegic and competitive sailing athlete who recently medaled at the 2012 Paralympics Games in London , will release her new book, On My Feet Again: My Journey Out of the Wheelchair Using Neurotechnology, October 23, 2012 at the Neurotech Leaders Forum in San Francisco. She uses a functional electrical stimulation (FES) system that was designed and developed at the Cleveland FES Center, a consortium of Case Western Reserve University, Veterans Administration and MetroHealth Medical Center. (Neurotech Reports)
Market Research Report Examines Neuromodulation Devices Forecast through 2018Oct. 17, 2012 - Transparency Market Research offers a report on the neuromodulation devices market, including global industry size, market share, trends, analysis, and forecasts from 2012 - 2018. The announcement lists major device companies as including Medtronic, St. Jude Medical, Boston Scientific, Cyberonics, IntraPace, Nevro, Johnson & Johnson, Codman, and Integra. (SBWire)
Follow-up Study Reviews Safety and Durability of Bladder Incontinence DeviceOct. 15, 2012 - Three of seven patients who were implanted with a tibial nerve stimulation device in 2003 continued to use the Urgent PC product by Uroplasty, Inc. regularly over nine years and sustained improvement in symptoms of overactive bladder, according to results to be presented at the annual meeting of the International Continence Society (ICS) in Beijing. (Herald Online)
Patent Issued for Powering Medical Implants Passively from an External SourceOct. 11, 2012 - Medtronic has received a new U.S. patent for a passive method of powering implanted medical devices wirelessly from an external source, including possibly having the source be located in chairs, blankets or clothing. (MassDevice) China, India Launch New Medical Regulatory GuidelinesOct. 9, 2012 - China's State Food & Drug Administration released instructions that will require Chinese labels or packaging marks on foreign medical devices as of April 1, 2013. Meanwhile, India's Drug Controller General of India has begun a special effort scrutinizing manufacturing processes for discrepancies, and is considering introducing a bill this winter on drugs, cosmetics and medical devices, due to a growing consensus that a separate governing law is needed for medical devices. (HealthpointCapital)
Market Report Predicts the Neuromodulation Market Size May Rival That of Cardiac DevicesOctober 2012 - A new market report segments the neuromodulation sphere into deep brain stimulation, transcranial magnetic stimulation, spinal cord stimulation, vagus nerve stimulation and peripheral nerve stimulation. It claims the market from 2012-2018 will benefit from growing demand for non-invasive treatment options and by addressing large patient populations in epilepsy, anxiety disorders, stroke, depression, Parkinson's disease and others. Overall, it predicts the neuromodulation market to become as big as the cardiac devices market. (Transparency Market Research)
Israeli Exoskeleton Maker Plans a U.S. Headquarters in MassachusettsOct. 2, 2012 - Argo Medical Technologies Ltd. announced it will open U.S. headquarters in Marlborough, Mass, as part of its entry into the U.S. market for its exoskeleton that allows paraplegics to walk. The ReWalk device is currently available for use at rehabilitation centers by multiple users, according to news reports. CE Mark approval was received in 2010 for the Israel company's system. (Boston.com) Hand Prosthesis Maker Creates Version Appropriate for Smaller and Younger AmputeesOct. 1, 2012 - Touch Bionics of Livingston, Scotland, has announced release of a compact version of its hand prosthesis that includes individual artificial fingers whose action is powered by batteries in a wristband. This version allows the i-Limb Digit to be fitted to smaller persons, as well as young teen-agers or possibly younger people, the company said. (The Scotsman)
News Feature Article Explores Neurostimulator Company's Status and Market ProspectsOct. 1, 2012 - Cyberonics' vagus nerve stimulators have been implanted in 55,000 U.S. patients with treatment-resistant depression since 1997; business in Europe is growing in double digits, and approval was received in Japan for the treatment of refractory epilepsy two years ago, where about 350,000 potential patients have treatment-resistant epilepsy. The $24,500 device's generator is about 3/4 of the total cost, and must be periodically replaced. Possible future markets may include depression and chronic heart failure. (Investor's Business Daily)
Analyst Firm Forecasts a $6.9 Billion Market by 2018, Examines Driving FactorsSept. 28, 2012 - Global Industry Analysts, Inc. reports the release of its comprehensive global report on neurostimulation markets. The firm identified more than 140 products in the development pipeline, and vagus nerve stimulation seems to be the fastest-growing intervention, at a projected 23%. The market is anticipated to reach $6.9 billion by 2018. (PR Web)
Minneapolis Back-Pain Neuromodulation Therapy Start-Up Secures $20 Million, Will Move to IrelandSept. 27, 2012 - Mainstay Medical, which targets chronic non-specific lower back pain, has obtained $20 million in financing and will relocate to Ireland from Minneapolis. Chief Executive Peter Crosby, a member of the International Neuromodulation Society, is quoted as saying the therapy is based on recent science, and that one societal benefit of improved therapy is returning people to work. (Irish Times)
Insurance Group in New England Will Cover Overactive Bladder Neuromodulation TreatmentSept. 26, 2012 - ConnectiCare of the Emblem Health family of insurers has begun coverage of percutaneous tibial nerve stimulation (PTNS) using Uroplasty Inc.'s Urgent PC system for overactive bladder. With the insurance coverage, the therapy is available to 240,000 ConnectiCare members. Also, the California Technology Assessment Forum has concluded that PTNS meets short-term benefit criteria. (PR Newswire)
Company to Present External Trigeminal Nerve Stimulation System at London Epileptology MeetingSept. 25, 2012 - At the 10th European Congress on Epileptology in London, NeuroSigma, Inc.'s external trigeminal nerve stimulation (TNS) system, Monarch eTNS, will be subject to a symposium Sept. 30 on TNS for epilepsy and neuropsychiatric disorders. Among the presenters will be International Neuromodulation Society member Ian Cook, MD, NeuroSigma senior medical advisor and professor of psychiatry at the University of California, Los Angeles. (Sacramento Bee)
CE Mark Approval Announced for Family of Neurostimulators to Treat Intractable Chronic MigraineSept. 20, 2012 - St. Jude Medical Inc. has received CE Mark approval for its Eon family of neurostimulators for patients with intractable chronic migraine. The company previously received CE Mark approval for European marketing of the industry's first-approved implanted neurostimulation device for this indication, the Genesis system. The new approvals include the rechargeable Eon mini and Eon systems and EonC (a non-chargeable option). (St. Jude Medical) U.S. Firm Partners with German Company to Fund Trial of Vagus Nerve Stimulation in EpilepsySept. 20, 2012 - Cyberonics, Inc. has invested EUR 2 million in cerbomed GmbH, becoming a minority shareholder and financing a current clinical trial in Germany of cerbomed's transcutaneous vagus nerve stimulation device, Nemos, for the treatment of epilepsy. Commercially available in Germany and Austria, the system received CE Mark approval for the treatment of epilepsy and depression in 20120, and pain in 2012. Houston-based Cyberonics developed and markets an FDA-approved vagus nerve stimulation system for the treatment of medically refractory epilepsy and treatment-resistant depression. Under the agreement, Cyberonics may invest up to EUR 5.5 million and optionally conduct a Nemos clinical trial in the U.S. (4-traders.com) FDA Permits Clinical Trial of Externally Powered Peripheral Nerve Stimulation Device for Post-Stroke Shoulder PainSept. 20, 2012 - Cleveland-based SPR Therapeutics has received clearance from the FDA to begin a randomized, controlled clinical trial of a minimally invasive peripheral nerve stimulation system for treating post-stroke shoulder pain. The system, Smartpatch, uses an external battery that snaps onto an adhesive patch to stimulate a lead placed on the deltoid muscle during an office procedure. About 60 patients will be enrolled in the safety and efficacy trial set to begin by the end of the year. (MedCity News)
Sept. 6, 2012 - A newly issued global bio-implants market forecast from 2012 to 2017 by Marketsandmarkets anticipates Asia will show a higher growth than the U.S. and Europe due to foreign investment and government funding there in a range of technologies, from neurostimulation to cardiovascular, orthopedics, and more. The report predicts the global market will grow from some $94 billion in 2012 to $134.3 billion in 2017. (PR Newswire)
External Trigeminal Nerve Stimulation System Receives CE Mark for Epilepsy, DepressionSept. 5, 2012 - NeuroSigma, Inc. received CE Certification for its external trigeminal nerve stimulation system, Monarch, for the adjunctive treatment of epilepsy and major depressive disorder in adults and children 9 years old and older. The system is composed on an external pulse generator and disposable electric patches that are placed on the forehead and replaced daily, and can be worn primarily at night during sleep. International Neuromodulation Society member Leon Ekchian, PhD, the company's president and chief executive officer, said approvals are being sought to commence a multi-center trial of the therapy in epilepsy in the U.S. and Europe. (Sacramento Bee)
Company Says FDA Clearance Obtained for Urinary Incontinence DeviceAug. 30, 2012 - Colorado-based Zynex, Inc. announced FDA 510(k) clearance of its InWave medical device, primarily used for treating female urinary incontinence. The company manufactures and markets diagnostic and electrotherapy devices, and recently opened a European subsidiary. (Reuters)
Vagus Nerve Stimulation Company Investors Anticipated to Seek Profits Following Positive First-Quarter ResultsAug. 28, 2012 - Cyberonics Inc. shares opened trading on Tuesday about 10% up after the company released first-quarter results that beat analyst expectations, then dropped to about 5% up near mid-day. Prices may decline slightly during the week as investors take profits, predicted the information service PropThink. The vagus nerve stimulation device company reported sales growth of 15% and income growth of 35% over the same quarter a year ago. (PropThink via Reuters) Wireless Transcutaneous Electrical Nerve Stimulation Device Receives FDA Marketing Approval for Back PainAug. 28, 2012 - The CNET blog "Crave" reported on the WiTouch wireless transcutantous electrical nerve stimulation device (TENS), recently cleared by the FDA for marketing for back pain in the U.S. In addition to this over-the-counter version, the device maker Hollywog of Chattanooga, TN, was also cleared to market the WiTouch Pro, a programmable version that can be used on the upper back and is available by prescription. (CNET)
Vagus Nerve Stimulation Company Due to Release Quarterly Earnings ReportAug. 24, 2012 - Cyberonics, Inc., which markets a vagus nerve stimulation system, was reported to be expected to release results for the first quarter of fiscal 2013, with an anticipated earnings per share of 36 cents on revenues of $58 million for the quarter. (Zack's Investment Research)
Market Report Places Size of Neurostimulation Market at $16.3 billion in 2011Aug. 17, 2012 - The "Markets for Electrostimulation Devices" report from notes that the neurostimulation market reached $16.3 billion in 2011 and has a moderate growth projection for the next few years. The report was recently issued by the life sciences research publisher Kalorama Information. (Healthcare Finance News)
Weight-Loss Neurostimulation Device Maker Seeks to Raise Additional CapitalAug. 15, 2012 - EnteroMedics, a weight-loss neurostimulation device maker, filed regulatory documents with the U.S. Securities and Exchange Commission to sell up to $75 million in stock, securities and warrants. Through exercising warrants, the device maker may issue more than 1.7 shares of common stock. (MassDevice)
Voiding Dysfunction Product Helps Boost Company's Revenue
July 26, 2012 - In Uroplasty Inc.'s first quarter of 2013, sales were up 40%, driven by a 64% increase in the sales of its Urgent PC Neuromodulation System to treat overactive bladder and related symptoms using percutaneous tibial nerve stimulation. (Market Watch) New Ohio-Based Medical Commercialization Network Will Focus on Neuromodulation and Other Emerging Technologies
July 24, 2012 - In what is described as the creation of the largest medical commercialization network in Ohio, neuromodulation will be one of the first areas of innovation to be targeted for commercialization under a new regional partnership, the Cleveland Plain Dealer reported. International Neuromodulation Society member Ali Rezai, president of the INS North American Chapter and director of the Ohio State University's Center for Neuromodulation, was quoted about the new partnership between Ohio State University and the Cleveland Clinic. The development was also reported by Med City News http://bit.ly/MmzBo6. (Plain Dealer)
Spinal Cord Stimulation Products are Addressed in Reports at Medical Conference
July 18, 2012 - International Neuromodulation Society member Stephen Pyles, MD, commented on an analysis that was awarded Best Poster at the 20th Annual Scientific Meeting of the International Spine Intervention Society, in which information from a database of more than 6,000 patients who were implanted with a Boston Scientific Precision Plus spinal cord stimulation (SCS) system showed that the group of patients who received the company's Clik Anchor system had more than 40 percent fewer revisions due to lead migration. Additionally, results were presented for 25 patients who underwent a SCS trial using the Infinion 16 Lead. Of those, 88 percent experienced significant pain relief and met criteria for a permanent implant. (Market Watch)
Quarterly Earnings Report Reflects Neuromodulation Growth
July 18, 2012 - In its second quarter earnings report, St. Jude Medical, Inc. reported that neuromodulation product sales were up 2 percent compared to the second quarter of 2011, to $106 million, and revenue increased 5 percent after adjusting for foreign currency. (Market Watch)
Neuromodulation Product Pipeline Volume is Described
July 13, 2012 - Coverage of a market report by GBI Research indicates there are 144 products in the neurostimulation pipeline. Deep brain stimulators are reportedly the largest component, comprising almost 17%, then vagus nerve stimulators, with 21 pipeline products, and spinal cord stimulators have just seven products expected on the horizon. (NeuroNews)
Analysts Initiate Coverage of Medtronic, Estimate a Stock Price 5% Ahead of Market
July 6, 2012 - Trefis Analysts initiated coverage of the medical device company Medtronic, with a stock price estimate of $41, which is about 5% ahead of the current market price for this leading medical device supplier. The analysis firm said neuromodulation accounts for about 11% of the company's stock price. (Trefis)
Market Research Firm Estimates that Neurostimulation Market May Double by 2018
July 3, 2012 - The global neurostimulation market, estimated at $2.3 billion in 2011, is expected to almost double by 2018 to $4.4 billion, with a compound annual growth rate of 10%. Market share of the three main manufacturers was reported to be 62% for Medtronic, 15% for St. Jude, and 13% for Boston Scientific. Electrical neurostimulation devices are becoming more common as the world's elderly population increases, Global Data reports. (PHARMABIZ.com) Company Announces Key U.S. Patents in High-Frequency Spinal Cord Stimulation
June 27, 2012 - Nevro Corp. announced two key patents covering aspects of its high-frequency spinal cord stimulation system to relieve chronic leg and/or back pain, Senza. The company's proprietary high-frequency waveform technology is designed to treat challenging conditions such as low back pain while avoiding the typical side effects that can occur with currently available systems (MarketWatch)
Medicare Changes to Only Covering Transcutaneous Electrical Nerve Stimulation for Clinical Trials
June 11, 2012 -- The Centers for Medicare and Medicaid Services will no longer cover most uses of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain, based a on a review prompted by a 2010 report by an American Academy of Neurology panel that found published reports presented conflicting evidence of effectiveness. The agency will cover randomized clinical trials of TENS for three years. (MedPage Today) Licensing Agreement Targets MRI-Compatible Leads for Vagus Nerve Stimulation System
June 11, 2012 - Cyberonics, Inc. has entered into an exclusive technology license agreement with Imricor Medical Systems, Inc. to develop magnetic resonance imaging-compatible leads for use with its vagus nerve stimulation system. (PR Newswire) CE Mark Granted for Vagus Nerve Stimulator to Treat Refractory Epilepsy
June 8, 2012 - Belgium-based Neurotech has received CE mark approval for its vagus nerve stimulation system to treat epilepsy patients who are refractory to anti-epileptic drugs and not eligible for surgery. The company's ADNS-300 uses a cuff electrode to record vagus nerve activity, which can be used to personalize the treatment. (Medical Device Network) Vagal Nerve Stimulation Device Company Reports Increased Earnings on Par with Estimates
June 6, 2012 - For the quarter that ended April 27, 2012, Cyberonics reported U.S. net sales increased 10% in the period, while international net sales grew 33%, on a constant currency basis. Net income and diluted earnings per share were both up, at $10.7 million and 38 cents per share respectively, compared to last year's $7.4 million and 26 cents diluted earnings per share. The company markets an FDA-approved vagus nerve stimulation (VNS) system for epilepsy and treatment-resistant depression, and said further growth is expected based on global replacement activity of VNS in epilepsy. The company repurchased $50 million in shares for the year, had $97 million in cash at the year's end, and met analysts' earnings estimates for the quarter. (Cyberonics)
Company Expected to Seek FDA Approval to Market Its Device to Treat Depression with Deep Transcranial Magnetic Stimulation
May 30, 2012 - Following a multicenter trial http://on.msnbc.com/LGskwE of deep transcranial magnetic stimulation in 233 patients suffering from treatment-resistant depression, Brainsway is expected to seek FDA approval to market its device in the U.S. in June. The initial trial results showed that after five weeks of treatment with the helmet-shaped device, some 30% of patients in the treatment group went into remission and 36.7% of patients showed more than 50% decrease in symptoms. The device delivers magnetic stimulation in a wider area of the brain than the more focused stimulation delivered by repetitive transcranial magnetic stimulation. (IEEE Spectrum)
Company Receives Commercialization Loan for Shoulder-Pain Device
May 24, 2012 - The Ohio Department of Development will loan SPR Therapeutics $900,000 to commercialize the company’s neurostimulation pain-relief system, designed to relieve post-stroke shoulder pain through peripheral nerve stimulation. (MedCity) Device Maker Reports Revenue Growth in Fourth Quarter
May 22, 2012 - In its fiscal year ended April 27, 2012, Medtronic, Inc. reported overall revenue growth, including neuromodulation revenue of $463 million, up 8% on a constant currency basis. Growth was driven by an increase in new implants in pain stimulation, deep brain stimulation (DBS), and stimulation for urinary and bowel incontinence indications. Growth in pain stimulation was driven by launches of its RestoreSensor(R) spinal cord stimulator with AdaptiveStim(R) technology in the U.S. and Japan. Sales of DBS products were driven by an increased focus on neurologist referrals. (BusinessWire)
Device Component Supplier Will Move Corporate Headquarters to Texas
May 22, 2012 - Medical device supplier Greatbatch Inc. announced it will move its corporate headquarters from outside Buffalo, N.Y. to Frisco, Texas, to be near medical technology firms, academic research centers, and an international airport. The company will maintain offices, manufacturing and research and development operations in western New York. (Dallas News)
Bioness Inc. to Market Foot Drop System for More Sizes May 15, 2012 - Bioness Inc. announced 510(k) clearance from the FDA to market a smaller leg cuff for use with its neuromodulation technology designed to treat foot drop, that causes difficulty walking for persons with motor deficits resulting from conditions such as stroke, multiple sclerosis, traumatic brain injury, spinal cord injury or cerebral palsy. The new cuff size provides access to the device for patients with smaller calf sizes. (Market Watch)
Sleep Apnea Device Company Receives Series C Financing, Completes Patient Enrollment
May 11, 2012 - Inspire Medical Systems, developer of neurostimulation therapies for the treatment of obstructive sleep apnea, has completed a Series C financing round of $14.5 million. Participating in this round of financing are new investors, Medtronic and TGap Ventures, and existing investors, including Kleiner Perkins Caufield & Byers, US Venture Partners, Synergy Life Science Partners and GDN Holdings. The company envisions filing a Pre-Market Approval application with the FDA in early 2013, based on a U.S. and European clinical trial, Stimulation Therapy for Apnea Reduction (STAR), for which patient recruitment and device implants have been completed. (MarketWatch)
Company Targets Diabetic Neuropathy with Transcutaneous Electrical Nerve Stimulator
May 8, 2012 - Neurometrix's president and CEO Shai Gozani, MD, is interviewed by a business development site about the company's pre-market approval by the FDA for a transcutaneous electrical nerve stimulation device to treat painful diabetic neuropathy. (onemedplace) Investment Firm Increases Stake in St. Jude Medical
May 7, 2012 - St. Jude Medical Inc.'s largest investor, Boston-based MFS Investment Management, reported in a regulatory filing it has increased its stake from owning about 8% of the medical device maker's stock to about 10%, a stake worth about $1.03 billion at the recent share price. (Mass Device)
Regional Medicare Contractor will Cover Posterior Tibial Nerve Stimulation for Overactive Bladder
April 26, 2012 - Novitas Solutions, the Medicare administrative contractor for approximately 4.6 million Medicare beneficiaries in Delaware, Maryland, New Jersey, Pennsylvania and the District of Columbia, will cover posterior tibial nerve stimulation (PTNS) services provided on or after April 9, 2012, based on a recent comparative effectiveness review entitled "Nonsurgical Treatments for Urinary Incontinence in Adult Women," published by the Agency for Healthcare Research and Quality (AHRQ), Uroplasty, Inc. announced in a press release. The company provides a minimally invasive PTNS treatment system, Urgent PC, for office-based treatment of overactive bladder and the associated symptoms of urgency, frequency and urge incontinence.(MarketWatch)
Greatbatch, Inc. Sees Sales Growth in First Quarter of 2012
April 26, 2012 - Neurostimulation component supplier Greatbatch, Inc. announced first-quarter 2012 results, including completed acquisition of NeuroNexus Technologies, which creates silicon-based electrodes and interconnects. Overall sales increased 7% to a record $159.1 million, although a lower gross profit, due to increased medical device investment and some production costs, was reflected in GAAP results and adjusted operating income. (MarketWatch)
Analyst Discusses Funding for Obesity Trial April 20, 2012 - EnteroMedics' recent round of financing should allow it to complete its Recharge trial that examines its vagus nerve stimulation device in control and treatment groups, and probably also continue to a product launch, comments an analyst who follows the company. (MedCity News)
Small Business Receives Grants for Motor Symptom Monitoring and High School Curriculum April 20, 2012 - Great Lakes NeuroTechnologies, which was spun out of Cleveland Medical Devices, has received a grant of about $3 million from the National Institute on Aging to enhance its technology that monitors Parkinson's disease symptoms at home, Kinesia HomeView. The platform uses a ring-like sensor worn on a finger to measure motor symptoms and transmit data about tremor. With the new funding, the platform will be enhanced to evaluate gait and balance. The company received an additional grant from the National Institute of Neurological Disorders and Stroke for a wireless physiological monitor and Web-based curriculum to teach neuroscience to high school students. (MedCity News)
Company Plans to Market a Transcutaneous Electrical Nerve Stimulator for Neuropathic Pain April 18, 2012 - Massachussetts-based NeuroMetrix, Inc. has filed premarket notification with the FDA for its non-invasive transcutaneous electrical nerve stimulator, Sensus, intended to relieve and manage symptoms of chronic intractable pain, such as painful diabetic neuropathy. (MarketWatch)
St. Jude Medical Neuromodulation Sales Grow by 12 Percent April 18, 2012 - In the first quarter of 2012, sales of neuromodulation products at St. Jude Medical, Inc. were $103 million, up 12 percent from the comparable quarter of 2011. (Seeking Alpha)
EnteroMedics Announces Additional Financing April 17, 2012 - EnteroMedics, Inc., the Minnesota-based the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, announced it has amended its existing debt agreement with Silicon Valley Bank to obtain an immediate $10 million loan. The agreement includes a provision for an additional $10 million loan on completion of primary endpoints in its ReCharge study and other financial objectives for 2012. In addition, the company plans a registered direct equity offering valued at $5 million. The financing will retire an existing $4.7 million debt and support work toward regulatory approval of the Maestro Rechargeable System in the United States, international commercialization efforts, and other development and operating expenses. (Marketwire)
Deep Brain Stimulation Device Maker Closes Financing Round April 10, 2012 - Aleva Neurotherapeutics, a company developing next-generation implants for deep brain stimulation, announced the closing of a Series B financing round totaling 4.0 million in Swiss francs. (Open PR.com)
First Commercially Available Vagal Blocking Systems for Obesity Shipped to Australia April 5, 2012 - EnteroMedics announced it has shipped its first commercially available MaestroRechargeable System for vagus nerve blocking therapy, VBLOC, designed to control both hunger and the feeling of fullness, to Australia. The company also said it has signed a multiyear distribution agreement to sell the system to countries in the Persian Gulf. (MedCity News)
Tissue-Securing System Now Permitted for Intrathecal Catheter Applications, Company Says April 4, 2012 - Anulex Technologies announced it has received FDA approval to expand indications for its fiXate™ Tissue Band. The product was previously approved for securing Spinal Cord Stimulation (SCS) lead anchors to fascia or interspinous/supraspinous ligaments in patients with chronic, intractable pain of the trunk and/or limbs. The new indication allows for securing intrathecal pain pump catheters in the same tissue. (Enhanced Online News)
Early-stage Medical Device Company Announces New Vice President for Neurology April 2, 2012 - NeuroSigma, an early-stage medical device company exploring new systems of trigeminal nerve stimulation for neurological disorders, has appointed its recent senior medical advisor, Christopher M. DeGiorgio, MD, to the new post of vice president, neurology. A professor of neurology at the University of California, Los Angeles, he was first to study TNS in patients with epilepsy, and collaborated with in developing TNS as a potential treatment for depression, PTSD and ADHD, the company said. (PR Newswire)
With an Approved Neurostimulation System for Overactive Bladder, is Small Company a Valuable Investment? March 23, 2012 - Minnesota-based Uroplasty has had FDA clearance since 2005 for its system to treat urge incontinence, Urgent PC, which uses percutaneous tibial nerve stimulation. An investment column explores the market being pursued by this small company, and its stock's investment value. (Seeking Alpha)
How Mature is the Market for Transcranial Direct-Current Stimulation? March 16, 2012 - A NeuroTech Zone blog looks at one company's intent to provide $99 mail-order devices for the non-invasive cortical stimulation approach transcranial direct-current stimulation. (NeuroTech Zone)
Neuromodulation Sales Increase in Medtronic's Third Quarter February 21, 2012 - Medtronic's neuromodulation business reported a 4 percent increase to $419 million in the third quarter of a fiscal year ending April 30. The growth was driven by strong InterStim Therapy sales. Also, the company received FDA clearance in the third quarter for the RestoreSensor spinal cord stimulator with the proprietary AdaptiveStim technology. (Becker's Orthopedic, Spine & Pain Management)
Device-maker Greatbach Pays $12 million for Neural Interface Developer NeuroNexus February 17, 2012 - Reuters reports that Greatbach, a leading pulse-generator component maker, acquired NeuroNexus for about $12 million. NeuroNexus develops neural interface devices across a wide range of functions including neuromodulation, sensing, optical stimulation and targeted drug delivery applications. Key NeuroNexus technologies, high-density silicon-based electrodes and interconnects, are more suited to neuroprosthetic rather than neuromodulation therapies, points out NeuroTech Zone, adding that the acquisition "brings us one step closer to a long-awaited clinical trial of probes developed using the semiconductor microfabrication technologies." (NeuroTech Zone, Reuters)
St. Jude Fourth-Quarter Report Shows Neuromodulation Growth February 3, 2012 - St. Jude's quarterly earnings report shows growth of the neuromodulation segment was up 12%. Overall revenues were up although that was offset somewhat by special charges. (Zack's)
Boston Scientific Announces CE Mark Approval and European Launch for Rechargeable Spinal Cord Stimulator InfinionTM 16 Percutaneous Lead February 3, 2012 - At the World Institute of Pain Conference, Boston Scientific announced it has received regulatory approval to begin marketing its Infinion 16 Lead in European CE Mark countries. Already marketed in the U.S., it is designed for use with the company's rechargeable Precision PlusTM Spinal Cord Stimulator System. The first patient implant in Europe using the InfinionTM 16 Lead was performed at the Sahlgrenska University Hospital in Guldheden, Sweden by by Kliment Gatzinsky, MD, Ph.D., and David Revesz, MD - both members of the International Neuromodulation Society. (PR Newswire)
Hybrid Imaging and Emerging Markets are Growth Areas for Medical Devices January 27, 2012 - The use of hybrid imaging technologies such as PET/CT and PET/MRI will see growth in the diagnostic imaging industry and will likely be a mainstay in future imaging, according to a report from GBI Research. The report also anticipates that the increasing demand for imaging in emerging markets, including China, India and Brazil, will balance the lower demand in developed countries, particularly the U.S., because of reimbursement cuts. (MolecularImaging.net)
Uroplasty, Inc. Reports 2011 Gains January 26, 2012 - Uroplasty, Inc. notes in its quarterly report that the Medicare carrier for Florida has released a formal, specific reimbursement policy for posterior tibial nerve stimulation (PTNS) that becomes effective February 1. The device maker has the only FDA-cleared PTNS system for office-based treatment of overactive bladder and urge incontinence. Headquartered in Minnetonka, Minnesota, with subsidiaries in The Netherlands and the United Kingdom, the company reported its net operating losses are down, and global sales increased 53% to $5.3 million in the third quarter of fiscal 2012, compared with $3.5 million in the fiscal third quarter a year ago. Sales in the U.S. grew 78%, with an 89% increase in sales of the Urgent PC Neuromodulation System and a 71% increase in sales of Macroplastique. Outside the U.S., sales rose by 19%. (MarketWatch)
EnterioMedics, Inc. Receives Australian Approval for Vagal Stimulator Targeting Digestive Functions, Reports Ongoing Medical Trial Spending January 26, 2012 - EnteroMedics Inc., which develops vagal neuroregulation devices to treat obesity, metabolic diseases and other gastrointestinal disorders by affecting the perception of hunger and fullness, announced final approval to commercialize its Maestro System in Australia. For the full year ended December 31, 2011, the company reported a net loss of $26.0 million, or $0.86 per share, and $29.7 million in cash and equivalents. Main operating expenses are for ongoing clinical trials, including the ReCharge Pivotal Trial, due to be unblinded by the end of 2012. In it, 233 patients are being evaluated at 10 sites to test effectiveness and safety of a second-generation Maestro System powered by a rechargeable integrated battery. All patients in the randomized, double-blind, parallel-group study are expected to participate in a weight management counseling program and receive an implanted device, with one-third of patients, in a control group, receiving a non-functional device for the duration of the study. (Newswire)
Cyberonics Announces FDA Approval of Re-Designed Generator for VNS Therapy
January 4, 2012 - Cyberonics issued a news release saying the FDA approved its re-designed AspireHC (High Capacity) generator for treatment-resistant epilepsy. The generator had been subject to a voluntary product withdrawal in August 2011, after the company learned that stimulation output current delivered to patients by the original units could be less than the output current programmed by a physician. (PR Newswire)

Industry News 2011 
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Spinal Modulation Raises $30 Million in Series D Financing June 15, 2011 - Investors include DeNovo Ventures, ePlanet/DFJ, InCube Ventures, Johnson & Johnson Development Corporation (JJDC), Kleiner Perkins Caufield & Byers, Medtronic, MedVenture Associates, and Raffles Venture Partners. The funding will be applied toward international clinical trials, with the hope of commercializing its spinal cord stimulation system outside of the US in the near future. (Enhanced Online News)
Medtronic Receives CE Mark Approval for Peripheral Nerve Stimulator May 23, 2011 - The peripheral nerve stimulator, which is not yet available in the US, is being used to treat chronic back pain. (Mass Device)
FDA Approves Neurostimulator to Treat Chronic Fecal Incontinence April 4, 2011 - The FDA has approved Medtronic's InterStim device, a sacral nerve stimulator used to improve or restore bowel control. The device previously had gained FDA approval for treatment of bladder dysfunction. (Bloomberg Businessweek)
Gastric Stimulator Receives CE Mark Approval March 29, 2011 - EnteroMedics' Maestro RC System, which uses electrical stimulation to suppress hunger, has received CE Mark approval in Europe. The company is conducting more clinical trials and is hoping to gain FDA approval for the device in 2012. (MedCity News) Boston Scientific Gains Approval to Market New Anchor March 24, 2011 - The FDA granted Boston Scientific to market the company's new Click Anchor for is spinal cord stimulation system which is used to treat chronic pain. (Boston.com)
FDA Approves Cyberonics' Generator February 1, 2011 - The US Food and Drug Administration has approved Cyberonics' AspireHC generator, which was designed to be coupled with the company's vagus nerve stimulation system to treat depression and epilepsy. (Bloomberg)
St. Jude Medical Receives Approval to Sell its DBS in Australia January 24, 2011 - The Australian Therapeutic Goods Administration has approved the Athena Programmer, which enables physicians to adjust deep brain stimulation parameters, and collect patient data for export and analysis. (MedCity News)
Boston Scientific Purchases Intelect Medical January 5, 2011 - Boston Scientific is acquiring Intelect Medical, a start-up company that is developing a visual programming system and direnal leactiods for deep brain stimulators, to enable clinicians to visualize the anatomical structures and target stimulation in patients. Boston Scientific is planning to use the programming technology with its Vercise deep brain stimulator, which is in clinical trials for the treatment of Parkinson's Disease. (Star Tribune)

Industry News 2010 and Earlier
Boston Scientific Abandons Plans to Sell its Neurostimulation Business December 13, 2010 - Boston Scientific ceased its efforts to sell its Neuromodulation Division a few weeks ago and has no further plans to pursue the sale. Analysts speculate that the company is reevaluating the potential for its neuromodulation business. (Bloomberg)
Tibial Nerve Stimulator Gains Coverage from Regional Medicare Carrier November 26, 2010 - Uroplasty Inc.'s posterior tibial nerve stimulator, used for the treatment of overactive bladder, is now covered by Palmetto GBA for California, Nevada and Hawaii. (Mass Device)
Boston Scientific Begins Deep Brain Stimulation Trial in Europe November 9, 2010 - Boston Scientific has announced the multi-center, prospective clinical trial of its Vercise deep brain stimulator for the treatment of Parkinson's disease. The study will examine motor function in approximately 40 European patients in whom the device will be implanted. The neurostimulator is not available for sale. (Mass High Tech)
Posterior Tibial Nerve Stimulator for Treating Overactive Bladder Receives Reimbursement Status November 3, 2010 - The Centers for Medicare and Medicaid Services have granted a Category 1 CPT code for Uroplasty's Urgent PC neuromodulation system, which is used for treating overactive bladder. (MedCity News)
Acuity Medical Systems Inc. has raised $1.5 million for the Development of Neurostimulation Technology to Treat Macular Degeneration October 1, 2010 - Acuity Medical Systems Inc., has raised $1.5 million from the sale of equity, to develop neurostimulation technology to treat dry macular degeneration. By stimulating the retina, the technology holds promise for restoring the normal balance of blood and oxygen flow in the area. (MedCity News)
Japanese Ministry of Health, Labor and Welfare Approves St. Jude Medical's Spinal Cord Stimulator September 30, 2010 - Regulators in Japan have approved the Eon Mini spinal cord stimulator for the treatment of chronic pain. (Mass Device)
InControl Medical Receives $700K U.S. in Funding for its Incontinence Therapy September 29, 2010 - InControl is developing a device to stimulate and strengthen the pelvic muscles of women who suffer from urinary incontinence. (Milwaukee Journal Sentinel)
The European Union Approves St. Jude Medical's New Deep Brain Stimulator Programmer September 20, 2010 – St. Jude Medical, Inc. has announced European CE Mark approval of its new Athena™ programmer, a deep brain stimulation (DBS) therapy management system. The programmer is a notebook-based PC that clinicians can adjust either through a touch screen or keyboard.
The European Union Approves Deep Brain Stimulator for The Treatment of Epilepsy September 16, 2010 - European regulators have granted Medtronic CE Mark approval for its deep brain stimulator for the treatment of refractory epilepsy. In the U.S., the FDA has yet to approve this device to treat epilepsy. (MedCity News)
Stryker Purported to Be in Talks with Boston Scientific's Neuromodulation Division August 17, 2010 - Bloomberg has reported that Stryker Corp., a maker of artificial hips and knees, is in advanced talks to buy Boston Scientific's Neuromodulation division for about $1.5 billion. If an agreement is reached, the announcement may be made next week. (Bloomberg)
FDA Approves Boston Scientific Leads August 2, 2010 - Boston Scientific Corp. was granted U.S. Food & Drug Administration approval for leads designed for use in its Precision Plus spinal cord stimulator system. (MedCity News)
EndoStim raises $6M in Venture Capital July 19, 2010 - EndoStim Inc., a start-up company that is making microstimulators to treat gastrointestinal and urological neuro-muscular disorders, has reported that it had raised $6 million in Series B equity financing. EndoStim would invest the money to continue clinical trials and pursue FDA approval for gastroesophageal reflux disease and urinary urge incontinence. (St. Louis Business Journal)
Neuros Medical Receives U.S. Government Funding for Stimulator to Treat Amputees' Pain July 2, 2010 - The U.S. Department of Defense has awarded $1.5 Million for the development of its neurostimulator to treat the chronic pain suffered by amputees, known as stump or phantom limb pain. The award's purpose is to “advance state-of-the-art solutions for world-class medical care with an emphasis on post-traumatic stress disorder, traumatic brain injury, prosthetics, restoration of eyesight and advancing eye care, and other conditions directly relevant to the injuries our service members are currently receiving on the battlefield”. (MedCity News)
Boston Scientific Corp. Has Released Two New Spinal Cord Stimulation Lead Splitters June 24, 2010 - The new design enables multi-site placement of up to four spinal cord leads, which will enable a greater range of lead configurations and treatment options. (MedCity News)
St. Jude Medical's Epiducer lead delivery system for neurostimulation therapy receives CE Mark approval May 27, 2010 – St. Jude Medical, Inc., today announced European CE Mark approval of its new Epiducer™ lead delivery system for neurostimulation therapy. Unveiled at the Neurosurgery 2010 Congress in Lyon, France, the Epiducer lead delivery system allows the introduction of S-Series perc-paddle leads as well as multiple lead arrays through a single percutaneous entry point, thus obviating the need to perform a laminotomy. (Med City News)
Spin-Off Device Companies Draw Venture Capital May 26, 2010 - Some of the larger device companies have accumulated more technology than they can fully pursue and, rather than abandoning potentially beneficial therapies, they are spinning off these low-priority products into new start-ups. Biotech venture firms have been known to back pharmaceutical spin-offs and now they are looking to do the same with device technology. (Wall Street Journal)
Medtronic to Invest $70M in BioControl May 24, 2010 - Globes in Israel reports that Medtronic Inc. (NYSE: MDT) will invest $70 million in a start-up company, BioControl Medical Ltd., which has developed a vagal nerve stimulator to treat heart failure. (Globes)
Dysphagia Wins a $25,000 Grant from the Innovation Fund of the Lorain County Community College Foundation May 24, 2010 - Dysphagia will use this grant to develop a prototype of its neurostimulator for clinical trials. The device, which uses a sensor in the mouth to detect a "swallow event", stimulates the trachea to close off the airway when food is being swallowed. (Massachusetts Medical Devices Journal)
Medtronic begins new spinal cord stimulator trials May 6, 2010 - Medtronic has announced a U.S. clinical trail for its RestorSensor Neurostimulator for the treatment of Chronic pain. The device automatically adjusts the stimulation strength, based on the patient's body position and activity. Ten U.S. medical centers will enroll patients in the study. The device already has received European approval. (Minneapolis St. Paul Business Journal)
Boston Scientific begins ‘Evidence’ clinical trial for Precision Plus spinal device May 3, 2010 - Boston Scientific has enrolled the first patient in the 132-patient trial, in which researchers will compare its spinal cord stimulator system with revision surgery for the treatment of failed back surgery syndrome. (Med City News)
Boston Scientific Eyes Selling its Neuromodulation Division April 9, 2010 - Reuters reported that Boston Scientific, in the aftermath of a costly recall of certain heart defibrillators and debt following its 2006 acquisition of Guidant Corp., is considering selling its neuromodulation and neurovascular intervention businesses. Abbott Laboratories and Johnson & Johnson have been identified as potential bidders for the neuromodulation business. (Reuters)
St. Jude Medical Receives Australian TGA Regulatory and Reimbursement Approval for its Rechargeable Deep Brain Stimulator for Parkinson’s Disease March 23, 2010 - St. Jude Medical, Inc. reported that its Brio deep brain stimulation system to treat Parkinson's disease symptoms received the Australian Therapeutic Goods Administration's regulatory and reimbursement approval. (RTTNews)
The Cleveland Clinic partners with Irish companies to develop new devices March 23, 2010 - The Cleveland Clinic has partnered with Irish start-up companies to support the development of new medical devices. The Clinic also has teamed with The Royal College of Surgeons of Ireland and the Centre of Innovation in Surgical Technology. (Irish Times)
Neurotech Reports Teams with International Neuromodulation Society for Online Database March 4, 2010 - The new Online Database of Neuromodulation Products offers comprehensive information on existing and forthcoming products to treat neurological disorders and diseases. (Neurotech Business Report)
Epilepsy Market Poised for New Device Competition March 4, 2010 - NeuroPace and Medtronic will soon join Cyberonics in the epilepsy device market. (Neurotech Business Report)
EnteroMedics CEO Offers Explanation for Failed Obesity Trial March 4, 2010 - The failure may stem from an unexpected therapeutic effect in the control arm of the study. (Neurotech Business Report)
Commentary: Focus on Epilepsy March 4, 2010 - Editor James Cavuoto comments on the market opportunity for neurosensing systems and neurosurgical tools created by neurosurgical treatment for epilepsy. (Neurotech Business Report)
OrbiMed Advisors raises $550M for health venture fund February 22, 2010 - OrbiMed Advisors, which has invested in Ohio companies Athersys Inc. and ViewRay, has raised $550 million for its latest health venture capital fund. OrbiMed plans to invest 60 percent of the fund in biotechnology, 30 percent in medical devices and 10 percent in diagnostics, and will back a total of 25 to 30 companies, according to VentureWire. (Med City News)
MicroTransponder Inc. raises $7M February 24, 2010 - The Austin company is testing a wireless neurostimulation platform that will treat chronic pain and other neurological indications. MicroTransponder did not name the investors, but said the latest contribution came from existing funders and angel investors. (Austin Business Journal)
Medtronic's Reclaim Deep Brain Stim Approved for Some OCD Sufferers February 20, 2009 - Medtronic's Reclaim deep brain stimulation system has received a humanitarian device exemption (HDE) from the FDA for treatment of severe cases of obsessive-compulsive disorder (OCD). (medGadget)
Case Western Reserve University licenses neuromodulation technology to Pennsylvania company February 17, 2010 - Case Western Reserve University has licensed to a Pennsylvania company the right to make and sell three types of electrodes and a control unit used by researchers to do their neuromodulation work. (Med City News)
Medical Device Entrepreneurs Converge on Wings, a New Angel Investing Network February 16, 2010 - People who make a living creating medical devices, like ultrasound machines or stents to prop open clogged arteries, have lived through a crummy 18 months. But that’s not discouraging a group of prominent medical device entrepreneurs from Seattle who are building the region’s first dedicated network of angel investors who have the money and expertise to bankroll new med-tech startups. (Xconomy News)
Medtronic launches 2 brain stimulation products February 16, 2010 - Medtronic Inc. said Tuesday it began marketing two surgically implanted devices that are intended to help relieve symptoms for patients with neurodegenerative diseases. (AP / Seattle Times)
Chip maker Zarlink puts big bet on medical sector February 12, 2010 - Five years after Kirk Mandy's return to resurrect Zarlink Semiconductor ZL.TO, the chief executive says the "heavy lifting" is done and it is time to see if strategic wagers will pay off for the one-time Canadian high-tech leader. (Reuters Canada)
Celebrating 30 Years Of Innovation In Neuromodulation, St. Jude Medical Unveils Latest Product At American Academy Of Pain Medicine Annual Meeting February 4, 2010 - St. Jude Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) clearance of the Swift-Lock(TM) anchor, a new product designed to help physicians efficiently secure neurostimulation leads utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. (Medical News Today)
St. Jude Medical Announces Approval And Launch Of Neurostimulation System In Japan January 19, 2010 - St. Jude Medical, Inc. announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Genesis(TM) spinal cord stimulation system for the management of chronic pain. (Medical News Today)
St. Jude Medical Receives FDA Approval for Industry-First Five-Column Neurostimulation Lead to Manage Chronic Pain December 4, 2009 - St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. market introduction of its new Penta™ surgical lead for neurostimulation therapy. Unveiled at the annual North American Neuromodulation Society meeting... (Genetic Engineering and Biotechnology News)
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