Cyberonics has presented an application regarding re-design of its AspireHC generator to both the US Food and Drug Administration (FDA) and its European notified body, DEKRA Certification.
Cyberonics develops the VNS therapy system which delivers electrical pulsed signals to the vagus nerve to treat refractory epilepsy and resistant depression.
Cyberonics president and CEO Dan Moore said they will work closely with regulatory bodies throughout the review process as necessary, but at this time, they don’t know when the reviews will be completed.
"We anticipate re-submission of the AspireSR generator for ethics committee and competent authority approvals for the resumption of the E-36 clinical trial in Europe no later than the end of fiscal 2012," Moore said.