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...
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.