NeuroVasx, Inc has received Canadian approval for cPAX Aneurysm Treatment System from Health Canada's Therapeutic Products Directorate to market the product in Canada. The system also received CE mark approval in March 2009.
Eric B. Timko, president and chief executive officer of NeuroVasx, said: This approval allows for our first commercial entry into the North American market and is another milestone in our effort to expand patient access to the cPAX System. We continue to work with the FDA on our 510(k) submission for cPAX and look forward to potential US regulatory approval and commercialization in the near future. We look forward to commercialization of cPAX to address the $450 million worldwide endovascular neurological device market.
The cPAX System is a minimally invasive device for the embolization of cerebral aneurysms, abnormal bulges or sacs in the wall of an artery in the brain. If ruptured, aneurysms can result in massive intracranial bleeding and often lead to death.
cPAX is a polymer strand delivered through a microcatheter using the same delivery technique as the currently used platinum coil technology. cPAX was designed to achieve more complete filling of the aneurysm using fewer devices and provide the physician the ability to detach the device at any point versus the fixed detachment zone common to platinum coils. The polymeric material also allows for non-invasive CT and MRI scans free of metallic artifact for a more accurate patient follow-up assessment.
Timko continued: We believe that physicians in Canada will appreciate the cPAX System’s ability to achieve superior aneurysm filling, especially in large aneurysms, along with its shorter procedure times and greater imaging qualities. The system will be particularly beneficial to Canadian patients with large cerebral aneurysms greater than 10 millimeters in diameter, for which current minimally invasive treatment options are often ineffective because of inadequate aneurysm filling. The inherent characteristics of the cPAX polymer are ideally suited to easily take on the shape of these aneurysms, maximizing packing of the material and leading to better outcomes.