LivaNova (NSDQ:LIVN) said today it won CE Mark in the European Union for its Vagus Nerve Stimulation Therapy system, now indicated for treating patients with drug-resistant epilepsy.
The VNS Therapy system is composed of the London-based company’s SenTiva implantable generator and a next-gen VNS therapy programming system.
LivaNova 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.
“CE Mark combined with recent FDA approval for the SenTiva generator and programming system advances VNS Therapy treatment for patients with drug-resistant epilepsy across the globe. Not only is the new VNS Therapy system simpler to use, making drug-resistant epilepsy treatment easier, the SenTiva generator and programming system work together to allow physicians to confidently deliver proven results through customizable, smart technology. After a successful launch in the U.S., we look forward to seeing European patients benefit from our latest technology advancements,” LivaNova neuromod GM Edward Andrle 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.
“SenTiva provides exciting advances in neuromodulation therapy for drug-resistant epilepsy. The smaller size and new programming features expand the range of patients we can treat. To that end, we are pleased to announce that the first SenTiva implant in a pediatric patient in Europe took place at King’s College Hospital in London,” Dr. David McCormick of London’s King’s College Hospital said in a press release.
Early this month, LivaNova said it closed its $250 million acquisition of cardiopulmonary temporary support solutions developer TandemLife .
