The HC generator is used in VNS Therapy System which uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve to treat refractory epilepsy and resistant depression.
Cyberonics President and CEO Dan Moore said with the CE Mark approval announced in December and a recently received Canadian approval, they will also resume the limited commercial release in Europe and start a limited commercial release in Canada.
"The AspireHC generator addresses a need among some patients for a device with a higher capacity battery and also provides a platform for the AspireSR seizure response generator, which is the subject of our E-36 clinical trial in Europe," Moore said.
"We anticipate submission of the re-designed AspireSR generator for ethics committee and competent authority approvals for the E-36 clinical trial no later than the end of our fiscal year in April 2012."
