NeuroVasx Receives CE Mark For CPAX Aneurysm Treatment System

Main Category: Neurology / Neuroscience
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics
Article Date: 26 Mar 2009 - 4:00 PDT

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NeuroVasx, Inc., a medical device company that develops technologies for the treatment of hemorrhagic and ischemic stroke, announced that it has received CE Mark for the cPAX Aneurysm Treatment System. 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 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."

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.

About NeuroVasx, Inc.

NeuroVasx, Inc. (http://www.neurovasx.com) is a privately held medical device company located in Maple Grove, MN. The company is dedicated to the development and commercialization of technologies for the minimally invasive treatment of hemorrhagic and ischemic stroke. The worldwide market potential for stroke treatment devices is estimated to be over $3 billion.

NeuroVasx, Inc.
http://www.neurovasx.com

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