Vagus Nerve Stimulation Therapy News This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

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 seen. At leas...
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 that, ...
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” sym...
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 recent FD...
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 patie...
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 Microbur...
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 RA. These tre...
Source: MDDI - March 26, 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 ro...
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. With the ...
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