FDA Says OK to New Aneurysm Device from Covidien

The U.S. Food and Drug Administration has approved a new device from Covidien to treat brain aneurysms, a bulging of blood vessels that can lead to nerve damage and even death.

The Pipeline Embolization Device, which was developmed by Covidien’s recently acquired ev3 unit (July of last year), is a flexible mesh tube that can be used to block off large aneurysms in a major blood vessel supplying blood to the front of the brain, the regulator said on its website. The device is implanted by attaching it to the end of a catheter, which is inserted into an artery in the leg.

The device can also reduce the likelihood that an aneurysm will rupture, FDA officials said.

The American Association of Neurological Surgeons estimates that every year 30,000 people in the United States experience a ruptured brain aneurysm.

Aneurysms are more prevalent in people ages 50 to 60 and three times more prevalent in women.