Health Canada issues marketing approval for NeuroVasx's cPAX Aneurysm Treatment System

Aug 27 2009

NeuroVasx, Inc., a medical device company that develops technologies for the treatment of hemorrhagic and ischemic stroke, announced today that it has received approval to market its cPAX Aneurysm Treatment System in Canada from Health Canada's Therapeutic Products Directorate. In addition to Canadian regulatory approval, the cPAX System also received CE Mark 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.

Mr. 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."

About Cerebral Aneurysms

A cerebral aneurysm is an abnormal bulge or sac in the wall of an artery in the brain which can be caused by a number of factors including congenital defects, high blood pressure, atherosclerosis, cancer, drug use or head trauma. If a cerebral aneurysm ruptures, it can lead to a hemorrhagic stroke, or bleeding on the brain. According to National Institutes of Health, approximately 40% of these patients do not survive the first 24 hours. The worldwide incidence of cerebral aneurysms is estimated to be 320,000 annually, approximately 200,000 of which may be treatable with intracranial surgery or minimally invasive techniques.

Source: http://www.neurovasx.com