FDA Approves VNS Epilepsy Therapy in Children as Young as Four

LivaNova PLC, has received FDA approval of its VNS Therapy system in patients as young as four years of age with partial onset seizures that are refractory to anti-epileptic medications.

Background

LivaNova VNS Therapy is a minimally invasive treatment option designed to prevent seizures before they start and stop them if they do.The system delivers regular, mild electrical charges to the Vagus Nerve (hence Vagus Nerve Stimulation) from a device that is implanted on an outpatient basis.  It has been used to date by more than 100,000 patients globally, but until now was only FDA approved for patients aged 12 and older. With the new indication, many children living with devastating drug-resistant seizures will have the opportunity for treatment beyond medication.

Physician comments

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 for Children’s Hospital Los Angeles.

“Epilepsy affects one in 26 Americans, and 35 percent of these patients fail to respond to medications,” said Dr. Holder. “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.”

Patient experience

Jayden is one of many children living with drug-resistant epilepsy. He lives in Australia where VNS Therapy is approved for all ages.

“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.”

“Next month, we’ll be three years seizure free with VNS Therapy,” continued Leah. “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.”

Company comments

“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, LivaNova’s Chief Executive Officer. “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.1,2,3

“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,” adds Jason Richey, LivaNova’s President of North America and General Manager of the Neuromodulation franchise. “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.”

 

Source: Business Wire

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