Cyberonics (NSDQ:CYBX) said it won FDA approval for its AspireSR generator designed for vagus nerve stimulation to treat drug-resistant epilepsy.
VNS is approved by the FDA to treat epilepsy by delivering electrical signals to the vagus nerve, which project to areas of the brain associated with seizures. Studies have shown a majority of drug-resistent epileptic patients experience a 50% to 90% reduction in seizures with VNS treatments, Cyberonics said.
The Houston-based medical device company said the AspireSR generator uses a proprietary, customizable cardiac algorithm to detect relative heart-rate increases and deliver automatic stimulation.
“The advantage of the AspireSR generator over the conventional VNS treatment is the ability to deliver stimulation when it may have the greatest beneficial effect,” Dr. Robert Fisher of Stanford’s Comprehensive Epilepsy Program said in prepared remarks..
Patients in the clinical studies of the device reported experiencing lower rates of seizures and reduced seizure severity, according to the company.
“From a physician’s perspective, the AspireSR generator is a very important development, because it is the only minimally invasive option we have that allows us to detect and respond to events in real time,” Dr. Micheál Macken of Northwestern University’s Feinberg School of Medicine said in a press release.
"The AspireSR generator is a groundbreaking advancement in VNS Therapy and represents the essence of our "DNA" technology – detect, notify, act. Our ability to design and implement algorithms that detect physiological conditions provides a foundation for this and future products and adds an important dimension to what ‘smart’ devices can accomplish to help improve the lives of patients globally," added CEO Dan Moore.
Plans for U.S. commercialization are slated to be released during an earnings call June 4, Moore said.
Last month, Cyberonics shareholders approved a merger with Italy’s Sorin Group (BIT:SRN). Sorin chief André-Michel Ballester is slated to be CEO of the new company, with Moore as chairman.