News Briefs from the International Neuromodulation Society

 

Government and Regulatory Issues News Feed

  

Company Says the FDA Has Cleared Its Manufacturing Plant

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

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

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

Device Maker Files Information Submission with the FDA

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

External Headache Devices Now Classified as Moderate Risk by the FDA

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

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

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

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

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

FDA Approves Implant for Sensorineural Hearing Loss

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

 

A Medical Technology Assessment Board is Formed in India

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

Overview of Proposed Active Implantable Device Regulations for European Union

May 30, 2013 - The European Union's proposed regulation of active implantable devices has clarified definitions; an active device relies on a source of power, which includes standalone software, while an implantable device is one that is intended to remain in place for at least 30 days. Demonstrating equivalence with another device would not generally be considered sufficient without gathering clinical data and clinical trials would be subject to a unified electronic system. (Mondaq)

FDA Medical device Appeals Process Clarified in Draft Guidance Open for Comment
May 16, 2013 - The FDA issued draft guidance for comment in the next 90 days about its appeals process for medical device marketing applications. For the first time, the agency clarifies what significant decisions would be eligible for a request for a summary of the rationale underlying the decision. (Mass Device)
 
Court Rules Italy Must Redesign Cuts to Medical Device Costs
May 14, 2013 - An Italian government move to cut prices for medical devices was invalidated in a court ruling that found the program, which had been scheduled to go into effect in January, was based on faulty use of a national medical device classification system and used inaccurate price sampling. Italian health care authorities must now come up with a different formula for implementing cost controls that recognizes the varied and specialized characteristics of the medtech sector, Clinica reported. (AdvaMed)

Proposed European Premarket Authorization of Medical Devices Questioned
May 13, 2013 - Clinica reports that two experts -- Erik Vollebregt of Axon Lawyers and Mika Reinikainen of AbNovo consultants -- believe that the European Parliament's proposal for pre-market authorization for medical devices would most likely be unwieldy if approved, but the politics of the issue are murky and the outcome of the debate unpredictable. Reinikainen believes the EU would do better to improve the current system, and Vollebregt added that the proposal is hostile to innovation by assuming that anything innovative carries more risk. (AdvaMed)
 
April 24, 2013 - The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on occipital nerve stimulation (ONS) for intractable chronic migraine. Selection of patients for treatment using ONS for intractable chronic migraine should be done by a multidisciplinary team, including specialists in headache, pain management and neurosurgery. Clinicians should enter details about all patients undergoing ONS for intractable chronic migraine onto the UK Neuromodulation Register when access to that database is available. NICE encourages publication of further information from comparative studies and from collaborative data collection to guide future use of this procedure and to provide patients with the best possible advice. Publications should include full details of any complications, and of adjunctive or subsequent treatments. Outcomes should include measures of pain, function and quality of life, particularly in the long term. (NICE)
 
Comment Sought on Proposed Revisions of Implantable Device Review in Australia
January 2013 - Through March 15, the Therapeutic Goods Administration in Australia is seeking comment on proposed revisions to its premarket review process for medical devices, including subjecting surgically invasive and implantable systems designed for long-term use to the agency's mandatory application audit and easing its lower-risk device rules. (Australian Therapeutic Goods Administration)
 
French Agency Seeks Input Prior to Updating Reimbursement of Neurostimulation Devices for Chronic Pain
January 16, 2013 - At the request of the Ministry of Health, France's cost containment agency (HAS) will publish a notice for public comment seeking input from all stakeholders including patients on an updated reimbursement list for neurostimulation devices, based on an assessment of each device’s effectiveness and the value of its therapeutic indications. HAS is undertaking a health technology assessment review of all implantable spinal neurostimulation devices, whether rechargeable or not, that are intended for the treatment of chronic pain and on the list of Reimbursable Products and Services. (Regulatory Focus)

Dutch Ministry of Health to Establish Device Registry to Track Complications
January 2013 - The Dutch Ministry of Health plans a national registry for patients who have received medical implants. In it, suppliers, producers, and insurance companies will be required to provide information on any device complications. (Dutch News via The Commonwealth Fund)
 
European Union Publishes Proposed Medical Device Regulations
Sept. 27, 2012 - Active implantable devices will be Class III devices under proposed regulations from the European Commission, intended to replace the current Medical Devices Directive, Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive. (Doanwa.com)
 
California Eliminates Duplicate Inspections of Medical Device and Drug Facilities
Sept. 28, 2012 - With passage of a bill by Assemblyman Jerry Hill (D-San Mateo) and Henry Perea, (D-Fresno), California has eliminated duplicate inspections of drug and medical device facilities that are already subject to oversight by the FDA. A similar measure was proposed in Congress, according to Pharmalot. (PR Web)
 
FDA Solicits Opinions on Post-Market Medical Device Surveillance Updates
Sept. 7, 2012 - The FDA is seeking comment (through FDA.gov) on four post-market medical device surveillance proposals, as reported in Healthcare Finance News:

1. Establish a unique device identification system and promote its incorporation into electronic health information.
2. Promote the development of national and international device registries for selected products.         
3. Modernize adverse event reporting and analysis.
4. Develop and use new methods for evidence generation, synthesis and appraisal. (Healthcare Finance News)

FDA Panel Recommends Humanitarian Device Exemption for Retinal Prosthesis
Oct. 1, 2012 - An FDA advisory panel recommended that the Argus II retinal prosthesis system by Second Sight Medical receive a humanitarian device exemption for patients who are severely blind due to the rare condition retinitis pigmentosa. The panel did raise questions about long-term safety, and called for continued study, according to a Mass Device article Sept. 27. (Mass Device)

European Union Publishes Regulations and Future Clinical Trial Mechanisms Regarding Medical Devices
Sept. 28, 2012 - The European Commission has published a "scrutiny mechanism" allowing input by authorities before medical devices go to market; also, its new proposals allow for a future, electronic, single clinical trial application for studies conducted in more than one member state. (AdvaMed SmartBrief)

Study Documents Benefits of Vagus Nerve Stimulation for Medicare Patients with Treatment-Resistant Depression
Sept. 6, 2012 - A retrospective analysis of Medicare claims from 2006-2009 comparing patients with managed depression, treatment-resistant depression, and those receiving vagus nerve stimulation (VNS) treatment indicates that carefully screened patients who have failed other therapies can respond to VNS treatment while costing the system less post-implantation. (Journal of Medical Economics)

Company Executive Discloses FDA Warning Letter About Processes for Handling Complaints
Aug. 21, 2012 - Medtronic Inc. was reported to have disclosed in a conference call that its neuromodulation device business received an FDA warning letter related mainly to its process for handling complaints. Overall, the company reported quarterly earnings in line with expectations during the same conference call. (Capital)

Argentinean Paper Highlights Regional Neuromodulation Initiative
Aug. 28, 2012 - International Neuromodulation Society members Fabian Piedimonte, MD, and Juan Carlos Andreani, MD, were mentioned as coordinating a new provincial neuromodulation treatment initiative announced by Health Minister Alejandro Collie at the second joint meeting of the Argentinian and Brazilian neuromodulation societies. They are president and vice president, respectively, of the Argentinean INS chapter, Sociedad Argentina de Neuromodulación (SANE). The meeting in Buenos Aires also involved INS President-Elect Tim Deer, MD, and Osvaldo Viela Filho, MD, PhD, president of the Brazilian chapter. (El Sol)

FDA Allows Clinical Trial Recruitment of Ischemic Stroke Patients
July 26, 2012 - Recruitment in the U.S. can begin for a clinical trial that examines the utility of electrical stimulation of the sphenopalatine ganglion to increase cerebral blood flow in the treatment of ischemic stroke (stroke caused by a blockage to blood flow). The approach aims to expand the treatment window which currently limits how many patients receive timely treatment. The trial was started at 57 medical centers in June 2011 by Israel-based BrainsGate Ltd., and involved 176 patients to date outside the U.S. With FDA permission to recruit clinical trial subjects in the U.S., the company expects to complete the trial on 450 patients in the fourth quarter of 2013. (Globes)

Under Proposed Regulatory Revision, Japan May Separate Device Approvals from the Drug Approval Process
July 2, 2012 - A proposed regulatory structure that separates medical devices from drugs is expected to be presented to the Japanese Diet when it reconvenes in January. (Clinica via AdvaMed SmartBrief)

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)

FDA Gives Clearance for Randomized Controlled Trial of High-Frequency Spinal Cord Stimulation
May 23, 2012 - International Neuromodulation Society (INS) member Leonardo Kapural, M.D., Ph.D, will be principal investigator for a U.S. randomized trial of high-frequency spinal cord stimulation, which is designed to provide chronic pain relief without the tingling, pins-and-needles feeling of parasthesia. Nervo Corp. announced FDA approval of the trial, SENZA-RCT, which will enroll up to 300 patients at 15 centers. An earlier prospective study in Europe, where the device is approved for marketing, showed effectiveness in reducing hard-to-treat back pain, according to results presented at the North American Neuromodulation Society's 2011 annual meeting by Jean-Pierre Van Buyten, M.D., chairman of the Multidisciplinary Pain Center AZ Nikolaas Sint-Niklaas, Belgium, who is also a member of the INS. (BusinessWire)

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)

Brain Simulation Effort Reportedly Short-listed for a £1billion European Union grant
April 17, 2012 - An international effort to simulate the complexity of a human brain down to the level of individual cells and molecules has been short-listed for a £1billion grant from the European Union. Led by Professor Henry Markram, Head of the neural microcircuitry laboratory at the Ecole Polytechnique Federale de Lausanne based in Switzerland, the simulation is intended to provide new insights into neurological diseases such as autism, depression, Parkinson's, and Alzheimer's, new ways of testing drugs and understanding the way they work, and to allow the scientists to design prosthetic devices to help people with disabilities. (International Business Times)

New England Region's Success in Gaining Reimbursement for Depression Treatment Recounted
March 30, 2012 - A Providence, R.I., newspaper article recounts three years of advocacy for reimbursement since the FDA approved repetitive transcranial magnetic stimulation (rTMS) for treatment of major depressive disorder in adult patients for whom traditional therapies have failed. In March, New England became the first region in the nation to put into effect a positive Medicare decision for covering this treatment. (PBN.com)

Medtronic Receives Health Canada Approval for Deep Brain Stimulation to Treat Refractory Epilepsy
March 15, 2012 - Medtronic, Inc. has received a Health Canada license for its deep brain stimulation (DBS) therapy for treatment-resistant epilepsy. The approval was based on Medtronic's clinical trial at 17 U.S. centers of 110 patients with medically refractory epilepsy with partial-onset seizures. The prospective, randomized, double-blind study, SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) examined the delivery of controlled electrical pulses to an area of the brain involved in seizures. Medtronic's DBS therapy for refractory epilepsy is also approved in Europe. (Medtronic)

Medicare May Deny Most Coverage for Transcutaneous Electrical Nerve Stimulation
March 14, 2012 - The Centers for Medicare and Medicaid Services issued a proposed decision memo advising that reimbursements for transcutaneous electrical nerve stimulation (TENS) should be available only for patients participating in randomized trials. In 2010 a research review by a panel of the American Academy of Neurology concluded the treatment was not proven effective for treating chronic low-back pain. Medicare currently covers FDA-approved TENS equipment and supplies when prescribed for chronic intractable pain, and provides reimbursement for physicians and physical therapists to assess patients' suitability for the treatment, which is typically done at home. (MedPage Today)

Obstructive Sleep Apnea Therapy Using Hypoglossal Nerve Stimulation Receives European Approval
March 14, 2012 - ImThera Medical Inc. has received European CE Mark approval to market its aura6000 (™) system for the treatment of obstructive sleep apnea. The system uses a patented method of hypoglossal nerve stimulation. (MarketWatch via ImThera)

U.S. Consumer Group Urges Tight Controls on Cranial Electrotherapy Stimulators
March 1, 2012 - Following up on a poster presentation from the 2009 meeting of the North American Neuromodulation Society, a chapter of the INS, an Ohio-based clinical team has published a two-year followup case of using spinal cord stimulation to manage post-surgical pain following lung cancer surgery. The patient reported improved quality of life and more than 75% reduction in pain. (Pain Management Nursing)

Unit Using Mild Electrical Stimulation Clears FDA for Female Urinary Incontinence
March 2, 2012 - InControl Medical announced the FDA has cleared InTone, a device that combines stimulation similar to transcutaneous electrical nerve stimulation, exercises, guided biofeedback and a pressure sensor to treat female urinary incontinence under a physician's guidance. (Renal & Urology News)

Small-Business TENS Suppliers to be Sought by U.S. Veterans Affairs
February 27, 2012 - The Department of Veterans Affairs' National Acquisition Center is seeking to determine if there are adequate small business concerns capable of providing transcutaneous electrical nerve stimulation items prior to potentially issuing a request for proposal. (FedBizzOpps.Gov)

Ireland Debates Providing Its Own Deep Brain Stimulation Service, Appoints an Assessment Panel
January 27, 2012 - Ireland's publicly funded Health Service Executive has asked for a health technology assessment about providing a national Deep Brain Stimulation service. The assessment by the nation's Health Information and Quality Authority will focus on developing a standard for the provision of such a service in Ireland (including staffing, equipment and other resources) and will evaluate the associated costs. It will then compare these with the current arrangements where eligible patients are referred, under the Treatment Abroad Scheme, to centers outside of Ireland for the surgery. (Health Information and Quality Authority)

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)

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)


Government and Regulatory Issues 2010 and Earlier

FDA Device Panel Considers Design of Clinical Trials for Treatment of Depression
October 11, 2010 -  The Neurological Devices Panel met to advise the US Food and Drug Administration (FDA) about the design of clinical trials of devices to treat severe depression. Though no firm recommendations were made, the panel considered several ethical issues, including the number of attempted and completed suicides in the patient population, the need for control groups, and acceptable response rates. (MedScape Today)

FDA Might Require Pump Manufacturers to Provide More Data
April 23, 2010 - The FDA issued preliminary guidelines that will require pump manufacturers to submit more test data, before the devices are approved for use. In addition, the companies would need to conduct limited clinical trials. (New York Times - requires registration)

The Council of Medical Specialty Societies Develops New Code of Ethics for Physician Interactions with Industry
April 21, 2010 - The council, which includes 32 medical societies, developed the code of ethics, which calls for greater transparency and for limiting the influence that drug and device companies have over patient care. (Associated Press)

FDA's Center for Devices and Radiological Health (CDRH) Launches New Transparency Website
April 20, 2010 - The FDA is providing information to help the public understand its regulatory decisions, and descriptions of regulatory processes. The new site also includes databases for premarket approvals and recalls and guidance documents. (FDA)

Improving the Security and Privacy of Implantable Medical Devices
April 2, 2010 - In a perspective article published in The New England Journal of Medicine, researchers make a case for risk-based security assessment to be included in premarket regulatory evaluation of devices. (MedPage Today)

Device Firms Seek Definition Of "New Science," As FDA Mulls Policy Changes
March 11, 2010 - FDA must better define what it considers "new science" when deciding how to incorporate emerging data into product reviews and post-market surveillance, and must vet the data carefully before reacting, device companies say. (Medical Devices Today)

NHS urged to buy Fairtrade and ethically sourced kit
February 27, 2010 - A new campaign has been launched to put pressure on the NHS to examine where its medical instruments come from. The British Medical Association (BMA) wants more Fairtrade and ethically sourced kit to be used. (BBC News)

Massachusetts medical device firms hurt by gift ban
February 26, 2010 - The Massachusetts law designed to prevent pharmaceutical and medical device firms from having undue influence on doctors is spurring job losses at local companies and research institutions, industry insiders claim. (Mass High Tech; The Journal of New England Technology)

Italy publishes long-awaited medical device regulations update
February 2, 2010 - Italian medical device regulations are about to come into force, featuring a May 5 deadline for the registration of products. A health ministry decree (DM) of December 21 2009, just published, comes into force on February 6, "replacing entirely" the February 20 2007 DM that currently regulates . (Requires a subscription on www.Clinica.co.uk)

Obama Budget Request Would Fund National Device Registry At FDA
February 8, 2009 - The Obama administration's fiscal year 2011 budget request includes $4 million for a new medical device registry that would link unique device identifiers to electronic health data. The registry would be designed and built by FDA. (Medical Devices Today)

 
     
Last Updated on Friday, September 19, 2014 01:40 PM
 
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