NeuroVasx Submits 501(k) for Cerebral Aneurysm Device

NeuroVasx, a Maple Grove, MN, company that makes devices for hemorrhagic and ischemic stroke, has submitted a 510(k) application for a new device that treats cerebral aneurysms.

The cPAX Aneurysm Treatment System is an aneurysm filler device, which, through a micro-catheter, delivers a polymeric strand into the aneurysm. It’s fully retrievable prior to detachment, and CT- and MRI-safe because of the materials used. In support of the 501(k), NeuroVasx submitted data from a recently completed study in South America in which 37 aneurysms were treated with the system.

Privately held NeuroVasx was founded in 1997 to produce diagnostic and therapeutic devices for the neurovascular embolization market. More specifically, the company is targeting intracranial aneurysms that, because of their morphology or location, or a patient’s general medical condition, are considered high risk for traditional operative techniques. According to data produced by Boston Scientific’s neurovascular division, up to one in 15 people in the U.S. will develop a brain aneurysm during their lifetime. It’s unclear how many of those would be candidates for a treatment like NeuroVasx’s.

cPAX has been underway since 2001, when the National Institutes of Health backed the company with a $140,000 grant. The effort was kept afloat through NeuroVasx’s own capital-raising efforts — in February 2004, it completed a $6.5 million private placement.

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