A Medical Device Daily
Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) reported that it has received FDA notification that the company's Andara Oscillating Field Stimulator (OFS) has been designated as a Humanitarian Use Device (HUD) for use immediately after (within 18 days) certain types of spinal cord injuries.
The designation allows Cyberkinetics to file a Humanitarian Device Exemption application with the FDA to use the Andara OFS to treat patients with acute, or recent, spinal cord injuries. Cyberkinetics said it expects HDE application filing later this year.
“We plan to base our HDE application on extensive preclinical data, as well as a published pilot clinical study, which indicate the potential for the device to allow patients with spinal cord injuries to regain some sensation and motor function,” said Timothy Surgenor, president/CEO of Cyberkinetics. “In addition to seeking accelerated approval to use the OFS device to treat acute spinal cord injuries, we are planning to expand the use of the OFS device to include the treatment of peripheral nerve injuries, strokes and traumatic brain injuries. Our goal is to develop the Andara OFS Device into a platform product applicable to a wide range of nervous system injuries.”
The company said that the Andara OFS has been shown in published preclinical studies to restore sensation and some motor function in a large animal model. Results of a 10-patient clinical study were published in the Journal of Neurosurgery: Spine (January 2005).
The Andara OFS device is based on research by the Center for Paralysis Research at Purdue University (West Lafayette, Indiana) and intended to improve or restore tactile sensation and some movement, in those with quadriplegia and tetraplegia due to recent spinal cord injuries, by promoting nerve fiber regeneration.