FDA Approves Vagus Nerve Stimulator for Refractory Epilepsy
SenTiva is the first FDA-approved VNS therapy for patients 4 years of age and older,
LivaNova announced that the Food and Drug Administration (FDA) has approved its vagus nerve stimulation (VNS) therapy, SenTiva, for patients with drug-resistant epilepsy. The device consists of SenTiva, an implantable generator, and the VNS Therapy Programming System, which includes a wireless wand and tablet for users to customize their therapy.
SenTiva is the first FDA-approved VNS therapy for use in patients 4 years of age and older. Previously, VNS therapy was only approved for patients ≥12 years of age. It includes a detect-and-respond mode, which is designed to prevent seizures before they start, and to deliver therapy to stop them if they do.
The VNS Therapy Programming System is also compatible with all LivaNova legacy VNS Therapy generators. In tandem with the SenTiva implantable generator, the system provides guided programming, scheduled programming, and day and night programming.
"SenTiva and the VNS Therapy Programming System will provide that additional flexibility and customization for our patients,” said Dr James Wheless, Professor and Chief of Pediatric Neurology of Le Bonheur Children's Hospital in Memphis, Tennessee.
LivaNova Receives FDA Approvals for SenTiva Device and Next-Generation VNS Therapy Programming System for Treatment of Epilepsy [press release]. LivaNova. http://investor.livanova.com/phoenix.zhtml?c=254127&p=irol-newsArticle&ID=2305354. Published October 9, 2017. Accessed October 13, 2017.