Healthcare Industry News: cerebral aneurysm
News Release - June 18, 2007
NeuroVasx, Inc. Announces 510(k) FDA Submission of its cPAX Aneurysm Treatment System(TM) for Treatment of Cerebral Aneurysms
MAPLE GROVE, Minn., June 18 (HSMN NewsFeed) -- NeuroVasx, Inc., a medical device company that develops technologies for the treatment of hemorrhagic and ischemic stroke, announced today that it has submitted its 510(k) application to the FDA for the cPAX Aneurysm Treatment System. The cPAX System was developed as a minimally invasive device for the embolization of cerebral aneurysms. A cerebral aneurysm is an abnormal bulge or sac in the wall of an artery in the brain. If ruptured, aneurysms can result in massive intracranial bleeding and often lead to death.In support of the 510(k) submission, NeuroVasx included data from their recently completed clinical study in which they treated 37 aneurysms in a single center study in South America.
"We are very pleased to have submitted our application to the FDA for our cPAX Aneurysm Treatment System. This 510(k) submission represents a significant milestone for the Company and our efforts to become a leader in the treatment of cerebral aneurysms. We look forward to receiving market approval," said Eric B. Timko, President and CEO.
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.
Source: NeuroVasx
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