LivaNova wins FDA nod for VNS therapy neurostim for young epilepsy patients

LivaNova (NSDQ:LIVN) said today it won FDA approval of its Vagus Nerve Stimulation Therapy system for patients as young as 4 years of age with partial onset seizures that are refractory to antiepileptic medications. The London-based company touted that with the clearance, its VNS Therapy system is the only FDA-approved device for drug-resistant epilepsy in the pediatric population. Previously, the device was only approved for patients ages 12 and older. “Epilepsy affects one in 26 Americans, and 35% of these patients fail to respond to medications. VNS Therapy offers many of these patients a chance for improved seizure control and a better quality of life. Controlling seizures in young children is life changing, allowing for improved development and educational successes that impact a child’s entire life,” Dr. Deborah Holder of the Children’s Hospital Los Angeles said in a prepared release. LivaNova said that every day in the US, 30 children experience seizures for the 1st time and will ultimately not be able to control them with medications alone. Every year more than 10,000 children under age 18 with drug-resistant epilepsy face the consequences of seizures, the company added, which could result in potential cognitive decline and missed developmental milestones. “Bringing VNS Therapy to children as young as age 4 in the U.S. is a huge opportunity to expand patient wellness and improve overall quality of life. We strive to provide value to patient...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance LivaNova Source Type: news