FDA approves LivaNova’s device combo to treat drug-resistant epilepsy

LivaNova snagged twin FDA approvals for an implantable generator and a programming system, which make up its Vagus Nerve Stimulation Therapy System for the treatment of drug-resistant epilepsy.

Epilepsy is most commonly treated with antiseizure drugs, but some people with epilepsy have a drug-resistant form of the disorder. Physicians may prescribe lifestyle changes, surgery or a medical device for these patients.

The SenTiva implantable generator and VNS Therapy Programming System—which consists of a handheld wireless device and user interface on a tablet—make up a physician-directed customizable therapy for patients with drug-resistant epilepsy, the company said in a statement.

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Sentiva is designed to deliver simulation to the vagus nerve to stop a seizure, as well as to to prevent seizures before they start, the company said. The device also records information associated with seizures, including body position and variations in heart rate.

“We created SenTiva and the accompanying VNS Therapy Programming System based on feedback received from patients and physicians to ensure ease of use, better patient care and cost effectiveness,” said Jason Richey, LivaNova’s president of North America and general manager of its neuromodulation business, in the statement.

“In addition, SenTiva’s compact size allows for a more comfortable experience for pediatric patients, which is beneficial now that VNS Therapy is the first and only system that is FDA approved for drug-resistant epilepsy in children as young as four years of age,” Richey said.