FDA Approves VNS Therapy Treatment for Drug-Resistant Epilepsy in Children as Young as Four Years Old
Expanded access to VNS Therapy treatment offers new hope for children with drug-resistant epilepsy
“Epilepsy can be a very trying and debilitating disease that can hold a
child back from reaching his or her full potential,” said
VNS Therapy—a minimally invasive treatment option designed to prevent seizures before they start and stop them if they do—has been used to date by more than 100,000 patients globally.4 Every day in the U.S., 30 children will experience seizures for the first time, and ultimately will not be able to control them with medication alone.5,6,7 That means, every year more than 10,000 children under the age of 18 years old with drug-resistant epilepsy will face the consequences of seizures, including head trauma, emergency room visits, fractures and hospitalizations.8 Without treatment beyond medication, these children may miss developmental milestones and face potential cognitive decline.9
“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
Jayden is one of many children living with drug-resistant epilepsy. He
“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.”
Being able to offer VNS Therapy to younger patients in the U.S. is a
game changer, according to Dr.
“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.”
About VNS Therapy® for Epilepsy
VNS Therapy® is the first and only
INTENDED USE/INDICATIONS –
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients four years of age and older with partial onset seizures that are refractory to antiepileptic medications.
Individual results may vary. Common side effects include hoarseness or changes in voice tone, prickling feeling in the skin, shortness of breath, sore throat and coughing. Visit www.VNSTherapy.com/important-safety-information to view safety and full prescribing information.
- Renfroe JB, Wheless JW. Earlier use of adjunctive vagus nerve stimulation therapy for refractory epilepsy. Neurology. 2002;59(6 Suppl 4):S26-30.
- Berg AT, Zelko FA, Levy SR, Testa FM. Age at onset of epilepsy, pharmacoresistance, and cognitive outcomes: a prospective cohort study. Neurology. 2012;79(13):1384-91.
- Otsuki T, Kim HD, Luan G, et al. Surgical versus medical treatment for children with epileptic encephalopathy in infancy and early childhood: Results of an international multicenter cohort study in Far-East Asia (the FACE study). Brain Dev. 2016;38(5):449-60.
Data on file,
LivaNova PLC, Houston, TX.
U.S. Census Bureau, www.census.gov/quickfacts/table/PST045216/00, accessed 5/22/2017
- Wirrell EC et al. Epilepsy Res. 2011 June; 95(1-2):110-118.
- Mohanraj R et al. Eur J Neurology. 2006; 13:277-282.
- Helmers SL et al. Eur J of Paed Neuro. 2012; 16(5): 449-458.
- Otsuki T et al. Brain & Development. 2016; 38:449-460.
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Important factors that may cause actual results to differ include, but
are not limited to: continued market acceptance of the VNS Therapy
System and sales of our products; adverse changes in coverage or
reimbursement amounts by the