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LivaNova Launches Study to Assess VNS Therapy in Drug-resistant Epilepsy Patients

September 12, 2018:  LivaNova PLC announced the first implanted patient and official launch of a global registry to evaluate the use of LivaNova’s Vagus Nerve Stimulation Therapy® (VNS Therapy) System for patients with drug-resistant epilepsy (DRE), which affects nearly one in three people with epilepsy.1 The Comprehensive Outcomes Registry in Subjects with Epilepsy Treated with VNS Therapy (CORE-VNS) 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 CORE-VNS will contribute to the body of research related to this disease state and advance the science behind VNS Therapy by evaluating the safety, effectiveness and clinical outcomes for patients. ...

Severe depression: Vagus nerve stimulator improves lives

For people with treatment-resistant depression, adding vagus nerve stimulation to medication can drastically improve their quality of life, concludes a new study. People with severe depression may benefit from the neurostimulation technique ‘vagus nerve stimulation.’ The National Institute of Mental Health suggest that over 16 million people in the United States have had at least one episode of major depression in the past year. Of these, more than 10 million adults report that the condition severely impaired their quality of life. There are a variety of treatments available for depression, including therapy, medication, and making changes to one’s lifestyle. However, for some, these therapies are not enough to relieve the symptoms and improve quality of life. Some with t...

LivaNova Commences Clinical Study to Evaluate Treatment Outcomes for Novel Microburst VNS Therapy System

LivaNova today announced the launch and enrollment of the first patient in a clinical study to examine the use of LivaNova’s new Microburst Vagus Nerve Stimulation Therapy® (“VNS Therapy”) System. This feasibility study will determine the initial safety and effectiveness of delivering VNS Therapy using high frequency bursts of stimulation (“Microburst”) in patients who have drug-resistant epilepsy (“DRE”).   “LivaNova is launching this study to enrich our understanding of epilepsy patient populations and the significant role VNS Therapy can play in the overall management of this disease”. “LivaNova is launching this study to enrich our understanding of epilepsy patient populations and the significant role VNS Therapy can play in the overall management of this disease,” said Edward And...

SenTiva Approved for Treatment of Epilepsy

Device billed as smallest, lightest responsive therapy for drug-resistant epilepsy   The SenTiva implantable generator and Vagus Nerve Stimulation (VNS) Therapy Programming System (LivaNova USA) have received FDA approval for the treatment of patients with drug-resistant epilepsy.   SenTiva is the smallest and lightest responsive therapy for epilepsy, LivaNova says. The new VNS Therapy Programming System features a wireless wand and new user interface on a small tablet. Together, the components offer patients with drug-resistant epilepsy a physician-directed customizable therapy with smart technology and proven results to reduce the number of seizures, lessen the duration of seizures, and enable a faster recovery, LivaNova says.

What is the vagus nerve?

The vagus nerve is the longest and most complex of the 12 pairs of cranial nerves that emanate from the brain. It transmits information to or from the surface of the brain to tissues and organs elsewhere in the body. The name “vagus” comes from the Latin term for “wandering.” This is because the vagus nerve wanders from the brain into organs in the neck, chest, and abdomen.

FDA Approves VNS Therapy Treatment for Drug-Resistant Epilepsy in Children as Young as Four Years Old

It was announced today that the FDA approves VNS Therapy® system (“VNS Therapy”) in patients as young as four years of age with partial onset seizures that are refractory to antiepileptic medications. This groundbreaking achievement makes VNS Therapy the first and only device that is FDA approved for drug-resistant epilepsy in this pediatric population. Previously, VNS Therapy was FDA approved for patients ages 12 and older. With this new indication, many children living with devastating drug-resistant seizures will have the opportunity for treatment beyond medication.

VNS Therapy Receives FDA Approval for Expanded MRI Labeling

VNS Therapy Receives FDA Approval for Expanded MRI Labeling “LivaNova” announced today that its latest VNS Therapy® systems received FDA approval for expanded MRI labeling, affirming VNS Therapy as the only epilepsy device approved by the FDA for MRI scans. This FDA approval ensures VNS Therapy patients with the latest technology may visit any MRI center in the U.S. and have access to more than 90 percent of scans routinely performed on patients with epilepsy.

Bristol vet joins children’s brain surgeon to treat epilepsy in dogs

Epileptic dogs are being fitted with implants normally used in humans in an attempt to treat the condition. Veterinary neurologist Tom Harcourt-Brown said implanting pacemakers, known as Vagus Nerve Stimulators(VNS), was potentially life saving”. Lyn Weber said four-year-old Eva was now a “bionic dog” 

Study shows continuous electrical stimulation suppresses seizures in patients with epilepsy

When surgery and medication don’t help people with epilepsy, electrical stimulation of the brain has been a treatment of last resort. Unfortunately, typical approaches, such as vagal nerve stimulation or responsive nerve stimulation, rarely stop seizures altogether. But a new Mayo Clinic study in JAMA Neurology shows that seizures were suppressed in patients treated with continuous electrical stimulation. Epilepsy is a central nervous system disorder in which nerve cell activity in the brain becomes disrupted. In the study, 13 patients with drug-resistant epilepsy were deemed unsuitable for resective surgery, which removes a portion of the brain — usually about the size of a golf ball — that was causing seizures. When patients are evaluated for surgery, a grid of electrical contacts ...

SUDEP Rate Lower in Epilepsy Patients After VNS

Results of a large long-term study suggest that patients with drug-resistant epilepsy treated with vagus nerve stimulation (VNS) have a reduced risk of sudden unexpected death in epilepsy (SUDEP). “It appears reasonable to conclude that VNS treatment in the long term significantly reduces the risk of SUDEP,” said Philippe Ryvlin, MD, PhD, Department of Clinical Neurosciences, CHUV, Lausanne, Switzerland. A study by Annegers and colleaguessuggested that SUDEP decreased with adjunctive VNS therapy, but this was not confirmed in another comparable study by Granbichler and colleagues. The current study increased the power of these previous two studies “by 100-fold,” said Dr Ryvlin. The new findings were reported here at the 2ndCongress of the European Academy of Neurolo...

Brain Implant that ‘Dissolves’ Over Time

An implantable brain device that literally melts away at a pre-determined rate minimizes injury to tissue normally associated with standard electrode implantation, according to research led by a team from the Perelman School of Medicine at the University of Pennsylvania. The researchers describe online in Nature Materials a new class of technology that provides greater resolution for measuring electrical activity in space and time that matches or exceeds existing methods. “Dissolvable silicon electronics offer an unprecedented opportunity to implant advanced monitoring systems that eliminate the risks, cost, and discomfort associated with surgery to extract current devices used for post-operative monitoring,” said senior co-author Brian Litt, MD, a professor of Neurology, Neuro...

New Wearable EEG!

Researchers have developed a wearable electroencephalogram (EEG) device that can detect and record seizure activity in epilepsy patients in the outpatient setting, they reported on Monday at the annual meeting of the American Epilepsy Society in Philadelphia. The so-called EEG Patch, a small, waterproof, scalp-mounted device, was designed to help patients more accurately track their seizures, Mark Lehmkuhle, PhD, a research assistant professor in neurosurgery at the University of Utah School of Medicine in Salt Lake City, who presented the findings at the meeting, told the Neurology Today Conference Reporter ahead of the session.   The EEG Patch is designed to be fixed to a part of the patient’s scalp where seizures are known to originate based on EEG recorded in-hospital during a traditio...

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