The US Food and Drug Administration (FDA) has approved LivaNova's vagus nerve stimulation (VNS) therapy (VNS Therapy) system for use as an adjunctive treatment in reducing the frequency of seizures in patients aged 4 years and older with partial-onset seizures refractory to antiepileptic medications, the company has announced.
Previously, VNS Therapy was approved for children aged 12 years and older.
According to the company, VNS Therapy is delivered through a device that sends mild pulses to the vagus nerve at regular intervals throughout the day in an effort to stop seizures before they start. An additional dose of therapy may stop or shorten the seizure, decrease its intensity, and shorten the recovery time. The device is implanted during a minimally invasive outpatient procedure that takes about 1 hour. It has been used by more than 100,000 patients globally.
"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," Damien McDonald, LivaNova's chief executive officer, said in a news release.
The most commonly reported side effects from stimulation include hoarseness, paresthesia, dyspnea, sore throat, and increased coughing. Other adverse events reported during clinical studies as statistically significant are ataxia, dyspepsia, hypesthesia, insomnia, laryngismus, nausea, pain, pharyngitis, and vomiting. "These typically occur only during stimulation, are well tolerated and noticed less as time goes on. The most commonly reported side effect from the implant procedure is infection," the company said.
"Epilepsy affects one in 26 Americans, and 35% of these patients fail to respond to medications," noted Deborah Holder, MD, director of the Comprehensive Epilepsy Program for Children's Hospital Los Angeles. "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," she said in the release.
More information about VNS Therapy is available online.
Cite this: FDA Okays VNS Therapy for Epilepsy in Children as Young as 4 Years - Medscape - Jun 30, 2017.