FDA Approves Device for Drug-Resistant Pediatric Epilepsy

LivaNova PLC recently announced FDA approval of the VNS Therapy system in pediatric patients with epilepsy. The device is indicated to treat patients as young as 4 years of age with drug-resistant partial onset seizures.

VNS Therapy is now the only device approved to treat pediatric patients, according to a press release. Previously, the device was approved to treat patients older than age 12, but the latest approval opens treatment options for pediatric patients who do not respond to traditional therapy.

“Epilepsy can be a very trying and debilitating disease that can hold a child back from reaching his or her full potential,” said Damien McDonald, chief executive officer, LivaNova. “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.”

VNS Therapy is a minimally invasive treatment designed to prevent seizures and stop them if they occur, according to the release. To date, the device has been used by more than 100,000 patients around the world.

VNS Therapy utilizes an implanted device that sends pulses to the vagus nerve at regular intervals throughout the day to stop seizures before they start, according to LivaNova. The device is implanted during a 1 hour outpatient procedure.

Each day in the United States, 30 children experience their first seizure and, eventually, are unable to control them with medication. More than 10,000 pediatric patients with drug-resistant epilepsy will experience head trauma, emergency department utilization, fractures, and hospitalization due to uncontrolled seizures, according to LivaNova.

Since these patients cannot be treated with drugs, pediatric patients may miss developmental milestones and experience cognitive decline, according to the release.

“Bringing VNS Therapy to children as young as age 4 in the US is a huge opportunity to expand patient wellness and improve overall quality of life,” said Jason Richey, president of North America and general manager of the Neuromodulation franchise, LivaNova. “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.”

In the release, LivaNova provides testimony from a mother whose child has drug-resistant epilepsy. After receiving VNS Therapy, the mother found that her child, Jayden, showed a dramatic improvement in quality of life.

“Growing up, Jayden was just like any other kid, before his epilepsy, anyway. His development stopped. He stopped progressing. He was seizing up to 300 times a day. Life was just a whirlwind of seizures and recoveries and appointments and medications,” Jayden’s mother said in the release. “Next month, we’ll be 3 years seizure free with VNS Therapy. He could never talk before and now, I’m having conversations with him. Now, we get to go and play. We get to go and do stuff. I don’t have to worry if I want to take him to the grocery store. It’s going to make me cry, thinking about just how far he’s come.”

For these patients, VNS Therapy has the ability to positively change lives, according to the release.

“Epilepsy affects 1 in 26 Americans, and 35% of these patients fail to respond to medications,” said 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."