HOUSTON, Jan. 3, 2012 /PRNewswire/ — Cyberonics, Inc. today announced that the United States Food and Drug Administration (FDA) has approved its re-designed AspireHC (High Capacity) generator, which was the subject of a voluntary product withdrawal in August 2011.
“We are pleased that the FDA was able to complete its review in approximately 60 days, enabling us to resume our limited commercial release of the AspireHC generator in the United States,” said Dan Moore, Cyberonics’ President and Chief Executive Officer. “With the CE Mark approval announced in December and a recently obtained Canadian approval, we will also resume the limited commercial release in Europe and initiate 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. 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.”
Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.
