FDA approves SenTiva nerve stimulation device for epilepsy therapy

By Dave Muoio
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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.

The treatment consists of the new SenTiva implantable generator, the VNS Therapy Programming System, a wireless wand, and a new smart tablet-based user interface. According to LivaNova, the SenTiva system is also the first device of its size to include detect-and-respond functionality, which allows the system system to deliver therapy that prevents seizures before they start and more quickly end them when they occur.

“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," Jason Richey, LivaNova's president of North America and general manager of the neuromodulation business franchise, said in a 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.”

Although the VNS System is compatible with all of LivaNova’s previous VNS Therapy generators, employing the new SenTiva generator provides additional features. These include time-sensitive scheduled programming; collection of body position, heart rate variation, and other data relevant to seizure events; and streamlined, one-touch programming through the tablet-based interface.

“Studies show that earlier use of VNS Therapy is proven to offer better long-term outcomes for children at a critical time in their development,” Dr. James Wheless, professor and chief of pediatric neurology at Le Bonheur Children’s Hospital in Memphis, Tennessee, said in a statement. “With VNS Therapy’s recently expanded age range, many more children living with drug-resistant seizures will have the opportunity for treatment beyond medication.”

LivaNova is the primary manufacturer of VNS implant devices, which are usually placed under the skin of the chest. Responsive neurostimulation (RNS) systems are the only other approved therapeutic devices for seizure prevention and control, and require implantation within the skull.

While direct prevention technologies may be limited to implants, noninvasive mobile health options are available when it comes to epilepsy monitoring. Empatica’s Embrace, a wearable specifically designed for seizure detection, was crowdfunded in 2015 and in late 2016 was tapped by pharma company Sunovion for use in a phase 4 clinical study of its seizure medication. More recently, Belgian-American health startup Byteflies announced in August that its wearable sensors would be used in another seizure study conducted by UCB. Also available is SAMi, a sleep activity monitor that detects unusual movement such as nighttime seizures and sends an infrared video feed to connected iOS devices.