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.
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.
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 “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.
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”
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...
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...
A new study involving UT Dallas researchers shows that vagus nerve stimulation (VNS) technology could help improve the lives of hundreds of thousands of people who suffer weakness and paralysis caused by strokes. The study, published in the journal Stroke, marks the first time that VNS has been tested in individuals recovering from stroke. VNS already has been approved by the U.S. Food and Drug Administration as a treatment for certain illnesses, such as depression and epilepsy. It involves sending a mild electric pulse through the vagus nerve, which is in the neck. Stimulating this nerve relays information about the state of the body to the brain and encourages it to reorganize in a process called neural plasticity.
With outposts in nearly every organ and a direct line into the brain stem, the vagus nerve is the nervous system’s superhighway. About 80 percent of its nerve fibers — or four of its five “lanes” — drive information from the body to the brain. Its fifth lane runs in the opposite direction, shuttling signals from the brain throughout the body.
Following FDA approval of the AspireSR® generator for the VNS Therapy® system inJune 2015, more than a thousand patients with drug-resistant epilepsy across the United States have received this new treatment option. Many of these patients are experiencing benefits which have positively impacted their lives – and are sharing their stories during Epilepsy Awareness Month with the hope of encouraging others to seek new treatments for drug-resistant epilepsy. Numerous hospitals nationwide have begun providing the AspireSR device to patients with drug-resistant epilepsy – a condition that affects as many as one-third of people with epilepsy, causing them to have seizures in spite of treatment with antiepileptic medications.2