WEDNESDAY, April 13, 2011 (HealthDay News) -- A new option to repair a difficult-to-manage bulging artery in the brain has been approved by the U.S. Food and Drug Administration.
Such a bulge, called an aneurysm, can grow and eventually burst. This can lead to a brain hemorrhage and even death.
Aneurysms larger than 10 millimeters, or those of an odd shape, often are difficult to treat. The cPAX Aneurysm Treatment System uses a special polymer to line the artery around the aneurysm, reducing the risk of rupture, the FDA said in a news release.
The system was approved under the agency's Humanitarian Device Exemption, which makes devices available for conditions affecting fewer than 4,000 people annually. The system was evaluated in small pair of clinical studies involving 43 people, the FDA said.
The cPAX system was approved for people 22 and older. It shouldn't be used in people with an active infection or among those who can't undergo anti-clotting therapy, the agency said.
The system is manufactured by Neurovasx Inc., of Maple Grove, Minn.
The FDA has more about this approval.