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

Video: Vagus nerve stimulation
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - February 27, 2019 Category: Consumer Health News 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. deaths—one study published in the JAMA Network Open1 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. “We clearly talk about ourselves as a company focused on the head and the heart,” Edward Andrle, LivaNova’s General Manager of Neuromodulation, told MD+DI. “What’s 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

Vagus nerve stimulation
(Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - January 26, 2018 Category: Consumer Health News 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

Electrocore closes $70m Series B
Electrocore said today it closed a $70 million Series B round of financing to support the commercial launch of its gammaCore therapy system into the primary headache market. The round was led by investment group Core Ventures II and joined by Merck’s Global Health Innovation Fund, Knoll Capital Management affiliate Gakasa, American Investment Holdings and the Vinik Family Foundation. Proceeds from the round are slated to be used for the commercial launch, as well as further studies, of its gammaCore device with a focus on the primary headache market. Funds will also support continued clinical and scientific developme...
Source: Mass Device - November 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation electroCore Source Type: news

electroCore Completes $70 Million Series B Funding Round
Investment to fund commercialization of gammaCore® and further clinical development of nVNS BASKING RIDGE, N.J., Nov. 29, 2017 -- (Healthcare Sales & Marketing Network) -- electroCore, a U.S.-based bioelectronic medicine healthcare company advancin... Devices, Neurology, Venture Capital electroCore, gammaCore, cluster headache, vagus nerve stimulation (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 29, 2017 Category: Pharmaceuticals Source Type: news

LivaNova swings to Q3 black
LivaNova (NSDQ:LIVN) today swung to profitability during the third quarter and raised its earnings outlook for the rest of 2017, after handily beating the consensus forecast on Wall Street. The London-based medical device company reported profits of $27.8 million, or 57¢ per share, on sales of $309.7 million for the three months ended Sept. 30, compared with losses of -$1.6 million during Q3 2016, for sales growth of 4.9%. Adjusted to exclude one-time items, earnings per share were 93¢, 15¢ ahead of consensus on The Street, where analysts were looking for sales of $300.5 million. “We delivered sol...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

LivaNova wins FDA nod for SenTiva VNS epilepsy treatment
LivaNova (NSDQ:LIVN) said this week it won FDA approval for its vagus nerve stimulation therapy system consisting of its SenTiva implantable generator and a next-gen VNS therapy programming system for treating patients with drug-resistant epilepsy. The London-based company 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. “We created SenTiva and the accompanying VNS therapy programming system based on feedback rece...
Source: Mass Device - October 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation LivaNova Source Type: news

4 trends in epilepsy research and care
Despite the fact that epilepsy is the third most common brain disorder — affecting an estimated one percent of children — there’s still much we don’t know about this condition. In fact, in about 75 percent of cases, epilepsy has no known cause. Research is crucial to help physicians learn more about the roots of epilepsy in children and develop potential treatments for it. “One third of our patients have treatment-refractory epilepsy. Unless we try to discover what causes an individual’s epilepsy, we can not take a personalized or precision approach to treatment. Parents should know that...
Source: Thrive, Children's Hospital Boston - October 11, 2017 Category: Pediatrics Authors: Jessica Cerretani Tags: Diseases & Conditions Dr. Annapurna Poduri epilepsy epilepsy center seizures Source Type: news

FDA approves SenTiva nerve stimulation device for epilepsy therapy
London-based medical device manufacturer LivaNova has announced FDA approval of its most recent Vagus Nerve Stimulation Therapy (VNS Therapy) System, which will be the smallest and lightest responsive therapy available for drug-resistant epilepsy patients aged four years and older. (Source: mobihealthnews)
Source: mobihealthnews - October 10, 2017 Category: Information Technology Source Type: news

ElectroCore raises $36m, looks to raise $29m more
ElectroCore has raised $36 million in a new round of equity and options financing, according to an SEC filing posted this week. The Basking Ridge, N.J.-based company is seeking an additional $29 million in the round to bring the total to $65 million. Funds raised so far have come from 31 unnamed investors, with the 1st sale dated on August 21, according to the SEC filing. Electrocore developed and produces the gammaCore non-invasive vagus nerve stimulator. The device won FDA approval in April and was launched in mid-July with indications for treating pain associated with episodic cluster headaches in adult patients. In Jun...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation electroCore Source Type: news

LivaNova shares rise on Q2 beat
Shares in LivaNova (NSDQ:LIVN) rose today after the medical device maker beat expectations on Wall Street with its 2nd quarter earnings results. The London-based company posted profits of $47.5 million, or 98¢ per share, on sales of $321.4 million for the 3 months ended June 30, seeing massive bottom-line growth of 427.8% while sales grew a smaller 0.1% compared with the same period last year. Adjusted to exclude 1-time items, earnings per share were $1.01, well ahead of the 82¢ consensus on Wall Street, where analysts were expecting to see sales of $315.6 million, which LivaNova topped. “We made progr...
Source: Mass Device - August 9, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat LivaNova Source Type: news

LivaNova wins CMS NTAP reimbursement for Perceval aortic valve
LivaNova (NSDQ:LIVN) said today that its Perceval sutureless aortic heart valve replacement won approval from the Centers for Medicare and Medicaid Services for a New Technology Add-On Payment. The London-based company said that the Perceval valve had met the CMS criteria for the add-on payment, including showing substantial clinical improvement over existing technologies. With the reimbursement approval, CMS will begin to reimburse hospitals for the Perceval valve procedure with the normal Medicare Severeity Diagnosis Related Group payment as well as an additional $6,110.23, LivaNova said. “We are pleased ...
Source: Mass Device - August 4, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) LivaNova Source Type: news

LivaNova wins MRI-safe CE Mark for VNS Therapy systems
LivaNova (NSDQ:LIVN) said today it won expanded CE Mark approval in the European Union for its Vagus Nerve Stimulation Therapy systems, now labeled as safe for 1.5T and 3T magnetic resonance imaging scans. The labeling change for the London-based medical device maker includes its AspireHC and AspireSR devices, allowing patients with existing devices to safely have MRI scans without the need for special equipment. “In addition to offering patients more seizure-free moments, we can now better support comprehensive epilepsy treatment throughout a patient’s lifetime,” neuromodulation biz GM Jason Ri...
Source: Mass Device - August 1, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neuromodulation/Neurostimulation Regulatory/Compliance LivaNova Source Type: news

ElectroCore launches gammaCore handheld VNS in US
Neuroscience tech developer ElectroCore said today it launched its gammaCore non-invasive vagus nerve stimulator, designed for the acute treatment of pain associated with episodic cluster headaches in adult patients, in the US. The Basking Ridge, N.J.-based company touted the device as the 1st non-invasive, hand-held vagus nerve stimulation device for the reduction of pain. The system is designed to be applied to the neck and applies a patented electrical stimulation through the skin to activate the vagus nerve. “We are proud to bring gammaCore to the U.S. market, as it provides episodic cluster headache suffere...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation electroCore Source Type: news