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Study Could Add More Depth to Bioelectronic Medicine
This study is one of several that weâre conducting and there are more coming out in the next few months,â he said. âI see this study and [the upcoming studies] as part of this big story that has to do with building the second generation vagus nerve stimulation therapies â that will be much more effective and much safer. It will allow a lot of flexibility to healthcare providers in individualizing the therapy to specific subjects.â (Source: MDDI)
Source: MDDI - June 9, 2020 Category: Medical Devices Authors: Omar Ford Tags: Digital Health R & Source Type: news
The effects of vagus nerve stimulation on the course and outcomes of patients with bipolar disorder in a treatment-resistant depressive episode: a 5-year prospective registry - McAllister-Williams RH, Sousa S, Kumar A, Greco T, Bunker MT, Aaronson ST, Conway CR, Rush AJ.
BACKGROUND: To compare illness characteristics, treatment history, response and durability, and suicidality scores over a 5-year period in patients with treatment-resistant bipolar depression participating in a prospective, multicenter, open-label registry... (Source: SafetyLit)
Source: SafetyLit - May 6, 2020 Category: International Medicine & Public Health Tags: Program and Other Evaluations, Effectiveness Studies Source Type: news
Medtronic Rumored to Be Looking at a Deal with LivaNova
Reorg Research reported that Medtronic is in early-stage acquisition talks withÂ LivaNova, news that has been well received by LivaNova shareholders. The firm said Medtronic would subsequently break up LivaNova, keeping its neuromodulation business and selling its cardiovascular business. The article does note, however, that Boston Scientific, Edwards Life Sciences, and Johnson & Johnson may also be interested in the London-based company. Mike Matson, an analyst at Needham & Co., performed a sum-of-parts analysis that values LivaNova's cardiovascular and neuromodulation businesses separately. His analysi...
Source: MDDI - February 28, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Cardiovascular Source Type: news
LivaNova and Verily in Research Agreement to Treat Depression
LivaNova has entered into a research partnership with Verily Life Sciences, an Alphabet company, to evaluate the effectiveness of Vagus Nerve Stimulation (VNS) therapy for Difficult to Treat Depression (DTD). The collaboration comes a few short months after London-based LivaNova ended its transcatheter mitral valve replacement (TMVR) program because of continued declines in revenue from its valve business. In the RECOVER clinical study, LivaNova and Verily aim to gather quantitative data on patient behavior using technology and analytics developed by Verily to further understand depressive episodes and a patientâ...
Source: MDDI - February 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news
Bioelectronic Research Tackles Hemorrhagic Shock
Jared Huston, MD, a trauma surgeon at Northwell Health on New York's Long Island, spoke straight to the point about the current state of treatment for hemorrhagic shock. While traumatic wounds to extremities can be treated with a tourniquet, such wounds suffered internally are often fatal unless the patient can be transported quickly to an operating room. "There are no efficacious approaches to treating noncompressible hemorrhage," Huston said. "That's really the problem. If you're injured intra-abdominally or in the chest, and you're not brought somewhere where a trauma surgeon can operate on you and stop t...
Source: MDDI - February 19, 2020 Category: Medical Devices Authors: Greg Goth Tags: Electronics Source Type: news
Feinstein Researchers Demonstrate Long-Term VNS on Mice
The Feinstein Institutes for Medical Research at Northwell Health presented data showing the effective use of a long-term vagus nerve implant in mice at the North American Neuromodulation Society (NANS) 2020 Conference in Las Vegas. Previous preclinical vagus nerve stimulation (VNS) studies have been limited to short-term stimulation - a timeframe of minutes to hours - due to the surgical and technological challenges of implanting a stimulator small enough to fit a mouse nerve. In order to conduct mouse studies lasting weeks or even months, Feinstein Institutes researchers, led by Stavros Zanos, PhD, MD, assistant professo...
Source: MDDI - January 28, 2020 Category: Medical Devices Authors: MDDI Staff Tags: Implants R & D Source Type: news
Auricular electroacupuncture for late posttraumatic epilepsy after severe brain injury: a retrospective study - Shen CC, Jiang JF.
BACKGROUND: Posttraumatic epilepsy (PTE) is a common complication of traumatic brain injury (TBI), which seriously affects patients' survival and recovery. Vagus nerve stimulation (VNS) is a nonpharmacological therapy for epilepsy. The auricular branch of ... (Source: SafetyLit)
Source: SafetyLit - November 20, 2019 Category: International Medicine & Public Health Tags: Environmental Issues, Climate, Geophysics Source Type: news
LivaNova Enrolls 1st Patient in RECOVER Depression Treatment Study
The objectives of the RECOVER study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity. The study will include up to 500 unipolar and up to 500 bipolar patients at as many as 100 sites in the U.S. RECOVER is a double-blind, randomized, placebo-controlled study with a follow-up duration of at least one year. The CMS study framework also includes the possibility to extend to a prospective longitudinal study. While VNS Therapy received CE Mark in 2001 and FDA approval in 2005 for the treatment of depression, last month,...
Source: MDDI - October 1, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Quick, Noninvasive Approach Promising for Migraine With Vertigo Quick, Noninvasive Approach Promising for Migraine With Vertigo
Noninvasive vagus nerve stimulation provides rapid relief of vertigo and headache in patients with acute vestibular migraine, results of a small study suggest.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - September 30, 2019 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news
Could a 'Tickle' a Day Keep the Doctor Away?
The tickle treatment is called transcutaneous vagus nerve stimulation (tVNS). The procedure involves placing custom-made clips containing electrodes on the part of your ear called the tragus; that's the small, pointed tip above your ear lobe. (Source: WebMD Health)
Source: WebMD Health - August 5, 2019 Category: Consumer Health News Source Type: news
Medical News Today: Vagus nerve stimulation may reduce the symptoms of rheumatoid arthritis
A new study suggests that electrostimulation of the vagus nerve may reduce the symptoms of rheumatoid arthritis and other chronic inflammatory conditions. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 24, 2019 Category: Consumer Health News Tags: Rheumatoid Arthritis Source Type: news
Vagal Stimulation Lessens Paroxysmal AF in Sham-Controlled Study Vagal Stimulation Lessens Paroxysmal AF in Sham-Controlled Study
AF burden fell significantly over 6 months for patients receiving electrical vagus nerve stimulation in daily 1-hour sessions in a small randomized study that invites confirmation in larger trials.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - May 16, 2019 Category: Cardiology Tags: Cardiology News Source Type: news
Non-invasive vagus nerve stimulation shows promise for treatment of rheumatoid arthritis
(Northwell Health) Bioelectronic medicine scientists at The Feinstein Institute for Medical Research collaborated with counterparts from Academic Medical Center at University of Amsterdam in the Netherlands to carry out a series of pilot clinical studies to assess the effect of a novel bioelectronic stimulation. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 16, 2019 Category: International Medicine & Public Health Source Type: news
LivaNova ’ s CMS vagus nerve depression device trial must include sham arm
A new U.S. Centers for Medicare & Medicaid Services trial of LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation Therapy system intended to treat treatment-resistant depression will require a sham-control arm, doubling the subject population LivaNova originally expected. The trial, which the London-based company won clearance from CMS for last month, will allow coverage for the VNS devices through a Coverage with Evidence Development framework. As revealed last month, the trial will be double-blinded, randomized and feature a follow-up of at least one year, the company said. New data, revealed in a posting on Clinical...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological LivaNova Source Type: news
Cala Health licenses MGH-developed neuromod tech
Cala Health said this week it inked a deal to license technology from Partners Healthcare and its affiliate Massachusetts General Hospital intended to improve the company’s non-invasive neuromodulation platform for investigating and treating chronic diseases. The licensed technology was developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation at a research lab in the MGH, the Burlingame, Calif.-based company said. “This collaboration with MGH’s cutting-edge research team provides a clear opportunity to accelerate development of wearable neuro...
Source: Mass Device - March 14, 2019 Category: Medical Devices Authors: Fink Densford Tags: Neurological Neuromodulation/Neurostimulation Research & Development Cala Health Source Type: news
LivaNova shares dip despite Q4, 2018 earnings beat
Shares in LivaNova (NSDQ:LIVN) fell today despite the medical device maker posting fourth quarter and full year 2018 earnings that topped expectations on Wall Street. The London-based company posted losses of $210.6 million, or $4.34 per share, on sales of $297 million for the three months ended December 31, seeing losses grow 88.5% while sales grew 6.7% compared with the same period during the previous year. Adjusted to exclude one-time items, earnings per share were $1.12, just ahead of the $1.10 consensus on Wall Street where analysts expected to see sales of $295 million, which the company topped. For the full yea...
Source: Mass Device - February 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news
LivaNova touts CMS trial clearance for vagus nerve depression treatment system
LivaNova (NSDQ:LIVN) said on Wednesday that the U.S. Centers for Medicare & Medicaid Services finalized a National Coverage Decision for LivaNova’s Vagus Nerve Stimulation Therapy for treating treatment-resistant depression. The London-based company said that the modified NCD will enable Medicare coverage for VNS therapy through the Coverage with Evidence Development framework when offered through a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up of at least 1 year. “As part of our commitment to improving the lives of patients around the world, LivaNova requested that ...
Source: Mass Device - February 21, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological LivaNova Source Type: news
fMRI gauges procedure to reduce PTSD pain
Could vagus nerve stimulation help ease pain from post-traumatic stress disorder...Read more on AuntMinnie.comRelated Reading: fMRI helps finds brain biomarkers linked to severe PTSD MRI could play role in curing digestive disorders fMRI shows dehydration's effect on the brain fMRI shows how game therapy 'rewires' ADHD brains fMRI shows how mindfulness training can help veterans (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 13, 2019 Category: Radiology Source Type: news
How Can Medtech Help with the Opioid Crisis?
Pain control is one of the biggest challenges facing America today, believes Dr. Peter Staats, co-founder and chief medical officer of electroCore. Chronic pain is an ongoing, debilitating problem for many patients, but for some, overuse of opioid treatments has led to addiction. Such a condition has led to an increasing number of U.S. deathsâone studyÂ published in the JAMA Network Open1Â found that the percentage of all U.S. deaths attributable to opioids increased 292% between 2001 and 2016. This same study reported that in 2016, 20% of deaths of adults aged 24 to 35 years involve...
Source: MDDI - January 18, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news
ElectroCore wins 5-year GammaCore federal supply deal
ElectroCore said yesterday it won a five-year Federal Supply Schedule Medical Equipment and Supply Contract with the U.S. Federal Government. Through the newly awarded contract, the Basking Ridge, N.J.-based company will supply its GammaCore non-invasive vagus nerve stimulation therapy to the Dept. of Veteran’s Affairs, the Dept. of Defense, the Bureau of Prisons, Indian Health Services and Public Health Services. The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to th...
Source: Mass Device - January 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological electroCore Source Type: news
ElectroCore wins cluster headache FDA 510(k) indication for GammaCore
ElectroCore said today that it won expanded FDA 510(k) clearance for its GammaCore non-invasive vagus nerve stimulation therapy, now cleared for adjunctive use for the preventive treatment of cluster headaches in adult patients. The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve. The expanded approval was supported by results from two studies which demonstrated the safety an...
Source: Mass Device - November 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance electroCore Source Type: news
CMS wants clinical trial for LivaNova ’ s neurostim depression device
The U.S. Centers for Medicare & Medicaid Services has proposed the launch of a clinical trial testing out LivaNova‘s (NSDQ:LIVN) Vagus Nerve Stimulation therapy system intended to treat Treatment-Resistant Depression as it looks to adjust its National Coverage Determination for the device. The London-based medtech company said that with CMS’ proposal to change the NCD for VNS Therapy, the agency could initiate coverage through its Coverage with Evidence Development as part of a CMS-approved study. The proposed study would be a double-blinded, randomized, placebo-controlled trial with a follow-up durati...
Source: Mass Device - November 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Neurological Neuromodulation/Neurostimulation LivaNova Source Type: news
VNS With Upper Limb Rehabilitation After Chronic Stroke VNS With Upper Limb Rehabilitation After Chronic Stroke
Is vagus nerve stimulation a useful adjunct to standard rehabilitation for improving arm function after chronic ischemic stroke?Stroke (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 19, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news
Can LivaNova Succeed Where Others Have Failed in HF?
LivaNova continues to live up to the promise it made to shareholders that it would focus more on its neuromodulation and cardiac surgery businesses. Through the VITARIA neuromodulation technology, the London and Houston, TX-based firm is fulfilling that promise with one device and one fell swoop. âWe clearly talk about ourselves as a company focused on the head and the heart,â Edward Andrle, LivaNovaâs General Manager of Neuromodulation, told MD+DI. âWhatâs interesting about this therapy is that it is a neuromodulation therapy. But th...
Source: MDDI - September 18, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news
LivaNova launches pivotal study for Vitaria heart failure device
LivaNova (NSDQ:LIVN) said today that it launched a pivotal study of its Vitaria neuromodulation implant for treating heart failure. The 800-patient Anthem-HFrEF study’s first subject was implanted with the Vitaria vagus nerve stimulation device at St. Luke’s Hospital in Cedar Rapids, Iowa, the London-based company said. Patients enrolled in the trial are slated to be randomized on a two-to-one ratio to be implanted with Vitaria or standard medical treatment. The primary endpoints are the event-free rate at 90 days from all device- and implantation-related serious adverse events and the composite rate ...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Featured Neuromodulation/Neurostimulation LivaNova Source Type: news
Depression Treatment: Where We Are Missing the Mark
Depression affects 450 million people worldwide and 15 million adults in the United States (U.S.) alone. Suicide is the 10th leading cause of death in the United States, claiming over 40,000 lives every year. We see these heartbreaking stories making headlines too often, and there are tens of thousands more we do not know about. The scariest part? There is no end in sight. Antidepressants are one of the three most commonly used therapeutic drug classes in the United States. Approximately 1 in 9 Americans of all ages reported taking at least one antidepressant medication — a number that was less than 1 in 50 just th...
Source: Psych Central - September 7, 2018 Category: Psychiatry Authors: Sachin Mehta, M.D. Tags: Antidepressants Bipolar Depression Medications Mood Stabilizers Neuroscience Suicide Treatment Deep brain stimulation Deep transcranial magnetic stimulation Depression Treatment Electroconvulsive Therapy Major Depressive Disorder Source Type: news
LivaNova launches global study of epilepsy treatment
The first patient with drug-resistant epilepsy has received LivaNova’s (NASDAQ:LIVN) vagus nerve stimulation (VNS) therapy system, kicking off enrollment of a global registry to evaluate it, the company said. Drug-resistant epilepsy (DRE) affects nearly one in three people with epilepsy, according to an article in the New England Journal of Medicine. The LivaNova study will enroll up to 2,000 patients with five-year follow-up data, yielding one of the largest data sets in the world for DRE patients treated with various generations of VNS therapy. Data from the CORE-VNS study will contribute to the body of research re...
Source: Mass Device - August 24, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Implants Neuromodulation/Neurostimulation Research & Development LivaNova Source Type: news
Medical News Today: Severe depression: Vagus nerve stimulator improves lives
A new study shows that vagus nerve stimulation, when added to medication, can drastically improve the lives of people with treatment-resistant depression. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - August 24, 2018 Category: Consumer Health News Tags: Depression Source Type: news
Depressed patients see quality of life improve with nerve stimulation
(Washington University School of Medicine) A national study led by researchers at Washington University School of Medicine in St. Louis indicates that people treated with vagus nerve stimulation experience significant improvements in quality of life, even when their depression symptoms don't completely dissipate. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 21, 2018 Category: International Medicine & Public Health Source Type: news
ElectroCore inks nVNS neuroinflammatory response research deal with MGH
ElectroCore said yesterday it inked a collaborative research deal with Massachusetts General Hospital exploring the use of ElectroCore’s non-invasive vagus nerve stimulation tech in targeted treatments for neuroinflammation. The Basking Ridge, N.J.-based company said that investigators will examine the effects the nVNS system has on neuroinflammatory mechanisms associated with conditions in the central nervous system including pain, trauma and neurodegeneration. ElectroCore said it will supply up to $1 million through a research grant over four years to support preclinical trials of the device, including work al...
Source: Mass Device - August 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological Neuromodulation/Neurostimulation electroCore Source Type: news
LivaNova beats Q2 expectations
LivaNova (NSDQ:LIVN) handily topped the consensus forecast for its second-quarter results despite a huge bottom-line slide. Formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015, in April the company closed the $190 million sale of its cardiac rhythm management business to China’s MicroPort Scientific (HK:00853) and paid $250 million to acquire TandemLife and its cardiopulmonary temporary support solutions. LivaNova also acquired ImThera and its implantable sleep apnea treatment for $225 million early this year. LivaNova posted profits of $15.1 mill...
Source: Mass Device - August 1, 2018 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news
Noninvasive Vagus Nerve Stimulation for Migraine Treatment: The PRESTO Study
Noninvasive vagus nerve stimulation may be a viable method for the treatment of acute episodic migraine, according to a new study. (Source: ConsultantLive)
Source: ConsultantLive - June 29, 2018 Category: Internal Medicine Authors: Veronica Hackenthal, MD Tags: Headache and Migraine Source Type: news
CMS Revisits Funding Vagus Nerve Stimulation for Depression CMS Revisits Funding Vagus Nerve Stimulation for Depression
Following a formal reconsideration request, the Centers for Medicare& Medicaid Services (CMS) may reverse a long-standing policy of not covering vagus nerve stimulation for resistant depression.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 20, 2018 Category: Consumer Health News Tags: Psychiatry News Source Type: news
SetPoint Medical touts 2-year relief from rheumatoid arthritis
Startup SetPoint Medical has demonstrated “significant, sustained improvement” over two years in a first-in-human study using bioelectronic therapy in patients with rheumatoid arthritis (RA). Seventeen subjects with moderate to severe symptoms were implanted with a vagus nerve stimulator in the European study. At three months, the therapy was shown to have significantly reduced RA symptoms and inhibited cytokine production, according to the company. After 24 months, 87% reported had clinically meaningful responses by standard Annual European Congress of Rheumatology (EULAR) criteria. The Santa Clarita, CA compa...
Source: Mass Device - June 19, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Bioelectronic Medicine Blog Neuromodulation/Neurostimulation Regulatory/Compliance Research & Development rheumatoid arthritis SetPoint Medical vagus nerve stimulation Source Type: news
Game-changer brain ‘pacemaker’ stops epileptic fits in their tracks
Simukai Shambira , aged nine, from Surrey, has become the first patient in Europe to be fitted with the SenTiva, which uses vagus nerve stimulation to stop epileptic seizures in a first for the NHS. (Source: the Mail online | Health)
Source: the Mail online | Health - June 17, 2018 Category: Consumer Health News Source Type: news
Will CMS Reverse Its Stance on LivaNova & #039;s VNS for Depression?
A device that previously received an unfavorable coverage decision for treatment-resistant depression from the Centers for Medicare & Medicaid Services will get a second shot after more than a decade. CMS said it will reconsider its national coverage determination for LivaNova's Vagus Nerve Stimulation (VNS) Therapy for treatment-resistant depression (TRD). LivaNova's implantable VNS devices are FDA approved for both drug-resistant epilepsy and treatment-resistant depression, but CMS currently only covers VNS for drug-resistant epilepsy. Although the outcome of the reconsideration process remains to be s...
Source: MDDI - June 1, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news
LivaNova touts CMS reconsideration of VNS therapy treatment for TRD
LivaNova (NSDQ:LIVN) today announced that the US Centers for Medicare & Medicaid Services are reconsidering a National Coverage Determination covering the use of vagus nerve stimulation technology for treating treatment-resistant depression. CMS last considered covering VNS treatment for TRD in 2007, but declined the coverage due to “insufficient evidence.” “In 1999, CMS established coverage of vagus nerve stimulation for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. In 2007, CMS reconsidered the NCD and determined th...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological LivaNova Source Type: news
Electrocore registers $75m IPO
Electrocore yesterday registered for an initial public offering worth nearly $75 million, detailing plans to expand its GammaCore device beyond the two headache treatments it’s already cleared for in the U.S. The Basking Ridge, N.J.-based company said in a regulatory filing that it plans to use the $74.8 million IPO’s net proceeds to expand its sales territories ahead of a full U.S. launch for GammaCore; R&D into other headache and rheumatology indications; and a specialty distribution channel for the GammaCore Sapphire device. The company would trade on the NASDAQ exchange under the “ECOR”...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Initial Public Offering (IPO) Neuromodulation/Neurostimulation Wall Street Beat electroCore Source Type: news
Frequency-dependent functional connectivity of the nucleus accumbens during continuous transcutaneous vagus nerve stimulation in major depressive disorder - Wang Z, Fang J, Liu J, Rong P, Jorgenson K, Park J, Lang C, Hong Y, Zhu B, Kong J.
Transcutaneous vagus nerve stimulation (tVNS) may be a promising treatment for major depressive disorder (MDD). In this exploratory study, fMRI scans were acquired during continuous real or sham tVNS from 41 MDD patients. Then, all patients received real o... (Source: SafetyLit)
Source: SafetyLit - April 23, 2018 Category: International Medicine & Public Health Tags: Suicide and Self-Harm Source Type: news
LivaNova wins CE Mark for SenTiva VNS epilepsy treatment
LivaNova (NSDQ:LIVN) said today it won CE Mark in the European Union for its Vagus Nerve Stimulation Therapy system, now indicated for treating patients with drug-resistant epilepsy. The VNS Therapy system is composed of the London-based company’s SenTiva implantable generator and a next-gen VNS therapy programming system. LivaNova touted the SenTiva generator as the smallest and lightest responsive therapy for epilepsy on the market. The system features a wireless wand and tablet-based interface to allow for physician-directed therapy for patients with drug-resistant epilepsy. “CE Mark combined with recen...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Neurological Neuromodulation/Neurostimulation Regulatory/Compliance LivaNova Source Type: news
LivaNova wins expanded CE Mark labeling for Bicarbon aortic valve
LivaNova (NSDQ:LIVN) said today it won expanded CE Mark labeling for its Bicarbon aortic heart valves, now cleared for use with low-dose anticoagulant therapy. The new approval clears low risk patients who’ve received a Bicarbon aortic valve implant to be targeted using a lower international normalized ratio measurement of blood coagulability, allowing for a lower-range level of anticoagulant medication therapy, the London-based company said. “When choosing a mechanical valve, patients look for a treatment option which lasts for life. The lower INR range approval for LivaNova Bicarbon Aortic Valves means p...
Source: Mass Device - March 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves LivaNova Source Type: news
LivaNova launches Microburst VNS drug-resistant epilepsy trial
LivaNova (NSDQ:LIVN) said today it launched a new feasibility trial of its Microburst Vagus Nerve Stimulation therapy system exploring its safety and effectiveness in treating patients with drug-resistant epilepsy. The London-based company said that Dr. Rebecca O’Dwyer of Chicago’s Rush University Medical Center has enrolled the first patient in the trial, which aims to enroll a total of 40 patients at 15 US sites. “At the Rush Epilepsy Center, we are very dedicated to research and advancing the field of epilepsy therapeutics for patients. It is an honor to have enrolled the first patient in the Micr...
Source: Mass Device - March 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological Neuromodulation/Neurostimulation LivaNova Source Type: news
Vagus nerve stimulation boosts post-stroke motor skill recovery
(University of Texas at Dallas) Researchers at The University of Texas at Dallas have demonstrated a method to accelerate motor skill recovery after a stroke by helping the brain reorganize itself more quickly. In a preclinical study, the scientists paired vagus nerve stimulation with a physical therapy task aimed at improving the function of an upper limb in rodents. The results showed a doubled long-term recovery rate relative to current therapy methods. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 27, 2018 Category: International Medicine & Public Health Source Type: news
Could This Device Replace Drugs for Rheumatoid Arthritis Treatment?
SetPoint Medical has launched a pilot trial to assess the safety and efficacy of a bioelectronics device in patients, who are suffering from rheumatoid arthritis and who are not adequately responsive to multiple biologic agents. The study will enroll a total of 15 subjects, aged 22 to 75, across seven U.S. investigational centers. Valencia, CA-based SetPoint's approach toward treating RA is designed to supplement the body's natural inflammatory reflex by providing "built-in" therapy and is intended to improve safety compared with drugs or biologic solutions. Currently pharmaceutical options are used to treat...
Source: MDDI - March 27, 2018 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Implants Source Type: news
Belgian neurostim dev Synergia Medical raises $10m in Series A
Belgian neurostimulation device developer Synergia Medical said this week it raised $10 million (EU €8.1 million) in a Series A round to help support its NAOS vagus nerve stimulation device designed to treat drug-resistant epilepsy. The NAOS system is a small-form, MRI-safe implanted neurostimulation device designed to stimulate the vagus nerve, with traditional wires replaced by optical fibers and photovoltaic cells that convert monochromatic optical energy into electrical impulses. Funds from the round will support final testing of the NAOS device as the company pursues CE Mark submission, Synergia Medical said. The...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological Neuromodulation/Neurostimulation synergiamedical Source Type: news
Electrocore wins FDA nod for GammaCore acute migraine treatment indication
Electrocore said today it won FDA 510(k) clearance for its GammaCore device, expanding indications to include the acute treatment of pain associated with migraines in adult patients. The Basking Ridge, N.J.-based company’s GammaCore device is a non-invasive, hand-held vagus nerve stimulation device designed for the reduction of pain. The system is intended to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve. “Migraine is a debilitating disease affecting 39 million Americans, the majority of whom do not seek medical care for their pain. W...
Source: Mass Device - January 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Neurological Neuromodulation/Neurostimulation Pain Management Regulatory/Compliance electroCore Source Type: news
gammaCore(R) Receives FDA Clearance for the Acute Treatment of Pain Associated with Migraine Headache in Adult Patients
First non-invasive vagus nerve stimulation therapy applied at the neck provides new option for Americans living with migraine BASKING RIDGE, N.J., Jan. 29, 2018 -- (Healthcare Sales & Marketing Network) -- electroCore, LLC (electroCore), a commercial-s... Devices, Neurology, FDA gammaCore, vagus nerve, neuromodulation, migraine, cluster headache (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 29, 2018 Category: Pharmaceuticals Source Type: news
LivaNova launches VNS treatment-resistant depression trial
LivaNova (NSDQ:LIVN) said yesterday it launched a new trial of its VNS therapy system exploring its use treating patients with treatment-resistant depression and that it enrolled the first patient in the trial. The first patient in the trial was enrolled by Karl-Jürgen Bär of Germany’s Universitätsklinikum Jena, the London-based company said. “Treatment-resistant depression, or difficult-to-treat depression, is an area of mental health in need of additional proven treatment options. Up to one-third of patients suffering from depression do not respond to several attempts at treatmen...
Source: Mass Device - January 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neuromodulation/Neurostimulation LivaNova Source Type: news