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 patients, caregivers and healthcare professionals across the globe. Today’s announcement, along with the recent FDA approval for our expanded MRI labeling, exemplifies how we continue to deliver on that promise,” neuromodulation biz GM Jason Richey said in a prepared statement.
“Epilepsy can be a very trying and debilitating disease that can hold a child back from reaching his or her full potential. Children with frequent seizures require urgent and careful treatment to prevent further delay in their development. The data from several 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,” CEO Damien McDonald said in a press release.
Last week, LivaNova said it won FDA approval for expanded MRI labeling for its Vagus Nerve Stimulation Therapy device, touting it as the only epilepsy device cleared by the FDA for MRI scans.
With the approval, patients with the minimally invasive VNS system are cleared to visit any MRI center in the US, with access to more than 90% of routine scans for patients with epilepsy, the company said.
