FDA Approves Seizure Device for Young Children


VNS Therapy was previously approved as a drug-resistant epilepsy treatment in seizure patients ages 12 and older.

The US Food and Drug Administration (FDA) has approved the partial onset seizure device VNS Therapy, the first and only approved device for drug-resistant epilepsy care in its pediatric population.

VNS Therapy has been approved for patients as young as 4 years old — having been previously approved for epilepsy patients ages 12 and older.

The device is a minimally invasive treatment option designed as both a prophylaxis for future seizures, and a treatment for seizures as they occur. It has been used by more than 100,000 patients globally, according medical technology company LivaNova PLC, and is particular beneficial in the US, where 30 children experience a seizure for the first time every day.

Due to the rate of drug-resistant epilepsy cases, more than 10,000 pediatric patients face the consequences of seizures.

"Children with frequent seizures require urgent and careful treatment to prevent further delay in their development." Damien McDonald, LivaNova Chief Executive Officer, said. "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."

Being able to offer VNS Therapy to even younger patients in the US provides opportunity to improve epilepsy patients' qualities of life, Jason Richey, LivaNova President of North America, and General Manager of the Neuromodulation franchise, said.

"We strive to provide value to patients, caregivers and healthcare professionals across the globe," Richey said. "Today’s announcement, along with the recent FDA approval for our expanded MRI labeling, exemplifies how we continue to deliver on that promise."

A press release regarding the approval was made available.

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