NeuroVasx, Inc., a medical device company that develops technologies for the treatment of hemorrhagic and ischemic stroke, announced today that it has received CE Mark for the cPAX Aneurysm Treatment System. The cPAX System is a minimally invasive device for the embolisation 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 a 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.
Eric B. Timko, President and Chief Executive Officer, said, “We are very pleased to receive CE Mark for the cPAX System. This initial clearance represents a significant milestone for NeuroVasx and our efforts to become a leader in the treatment of cerebral aneurysms. We believe that cPAX offers substantial advantages over traditional platinum coils. cPAX reduces the amount of devices per procedure simplifying the delivery and shortening procedure times. Its soft, pliable material allows for packing densities of up to 60%, a particularly important advantage when treating larger or wide necked aneurysms. We look forward to the pending 510(k) clearance of cPAX followed by our initial U.S. commercialization efforts.”