The U.S. Food and Drug Administration (FDA) recently approved LivaNova’s VNS Therapy Systems for the treatment of drug-resistant partial onset epileptic seizures in children as young as 4, making it the only approved device for treating refractory epilepsy in children.
“Epilepsy can be a very trying and debilitating disease that can hold a child back from reaching his or her full potential,” Damien McDonald, LivaNova’s CEO, said in a press release. “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 device that sends frequent pulses to the vagus nerve — a major route of communication between the brain and the rest of the body. In this way, the device prevents seizures from developing. If a patient does have a seizure while using the treatment, the pulse frequency can be increased to shorten or stop a seizure.
“Bringing VNS Therapy to children as young as age four in the U.S. is a huge opportunity to expand patient wellness and improve overall quality of life,” said Jason Richey, LivaNova’s president of North America and general manager of the Neuromodulation franchise.
Up until now, the treatment was approved for children ages 12 and older in the U.S. In Australia, however, the device has been approved for children of all ages.
One of the patients treated in Australia was Jayden. “Growing up, Jayden was just like any other kid, before his epilepsy, anyway,” said Leah, Jayden’s mother.
“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,” Leah said, adding that Jayden has now been free from seizures for three years using the VNS Therapy device.
“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,” Leah said.
Being able to offer VNS Therapy to younger patients in the U.S. is a game changer, according to Dr. Deborah Holder, director of the Comprehensive Epilepsy Program at 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,” Holder said.
The FDA also recently approved certain VNS Therapy models to be used during magnetic resonance imaging (MRI) of the brain.