Epilepsy Foundation Leadership Addresses FDA Panel on New Medical Device for Seizures
February 22, 2013
February 22, 2013, WASHINGTON -- Epilepsy Foundation President and CEO Phil Gattone and Board member Warren Lammert spoke before the Food and Drug Administration's Neurological Devices Panel of the Medical Devices Advisory Committee, which is reviewing the NeuroPace RNS® System for the treatment of partial onset seizures.
The RNS System is surgically implanted under the skin on the skull and records electrocorticographic (ECoG) patterns via electrodes. The device delivers short electrical pulses intended to interrupt the triggers in the brain that cause epileptic seizures.
The system lowered the rate of seizures by 37.9% during a 3-month blinded evaluation period when turned on, compared with 17.3% when not turned on (P=0.012), briefing documents released ahead of an FDA advisory committee meeting showed.
"Epilepsy needs new, effective therapies. The RNS is one good option," said Warren Lammert, co-founder of the Epilepsy Therapy Project and the father of a daughter living with epilepsy. "Moreover, it is a novel approach that offers a new window on epilepsy and a path to further progress in our understanding and treatments. All new therapies involve unknowns and risks, but the risks of uncontrolled seizures and epilepsy are known, are severe and in fact destroy lives and too often take lives through SUDEP and other epilepsy related mortality."
"I want to share some of the voices I hear every day from our community of affiliates, advocates, and families from across the nation," said Epilepsy Foundation President and CEO Phil Gattone, who is also the father of a son living with epilepsy. "We are facing a world where it has been over 15 years since a device was approved for epilepsy treatment. The frustration of the Foundation and the epilepsy community is that the access to new treatments should keep pace with innovation. It is our hope that work you do today and in the future will not only help pave the way for access to innovative therapies, but also spark the interest and enthusiasm for creating new devices to treat epilepsy. I am so thankful for this committee's time and attention to this issue, and I hope that I can shed some light on the stories and concerns I hear every day from across the country."