LivaNova (NSDQ:LIVN) said this week it won FDA approval for its vagus nerve stimulation therapy system consisting of its SenTiva implantable generator and a next-gen VNS therapy programming system for treating patients with drug-resistant epilepsy.
The London-based company touted the SenTiva generator as the smallest and lightest responsive therapy for epilepsy on the market. The system features a wireless wand and tablet-based interface to allow for physician-directed therapy for patients with drug-resistant epilepsy.
“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. 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,” LivaNova neuromod biz GM & NA prez Jason Richey said in a prepared statement.
LivaNova said the SenTiva device features the ability to detect and respond to seizures to prevent them before they start, and can send extra therapy to stop them if seizures have already begun. The system also collects and logs associated events including body position and heart rate variations.
“Since every patient suffering from seizures is different, we need more treatment options. SenTiva and the VNS therapy programming system will provide that additional flexibility and customization for our patients. SenTiva is especially ideal for our pediatric patients. With VNS therapy’s recently expanded age range, many more children living with drug-resistant seizures will have the opportunity for treatment beyond medication. 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 of Memphis, Tenn.’s Le Bonheur Children’s Hospital said in a press release.
Late last month, LivaNova and MicroPort Scientific (HKG:0853) said that the group’s joint venture, MicroPort Sorin Cardiac Rhythm Management Co., won approval for its family of Rega pacemakers in China.