Device Approved to Treat Brain Aneurysm
WEDNESDAY, April 6 -- A new device to treat an arterial bulge (aneurysm) in the brain has been approved by the U.S. Food and Drug Administration.
Over time, a person's normal blood pressure can cause an aneurysm to grow larger and burst, which could be life-threatening. A ruptured brain aneurysm affects about 30,000 people each year in the United States, the FDA said in a news release, citing an estimate from the American Association of Neurological Surgeons.
Aneurysms are most common in people aged 50 to 60, and are three times more common in women than men, the FDA said.
The newly approved Pipeline Embolization Device is a metal mesh tube that is implanted in the internal carotid artery, a primary supplier of blood to the brain. The device is meant to cut off blood flow to the aneurysm and to reduce the likelihood of the artery's rupture, the agency said.
The device is implanted by feeding a catheter into the carotid artery via insertion into a leg artery. Aneurysms successfully treated with the device often shrink over time, the FDA said.
The product was evaluated in a clinical study involving 108 people aged 21 to 75 who had a certain type of aneurysm in the internal carotid artery. After one year, 70 percent of aneurysms remained blocked off without a meaningful narrowing (stenosis) of the affected section of artery, the FDA said.
The study found that ten strokes occurred among nine people in the year after initial treatment, the agency said. Minor adverse reactions included headache, bleeding, nausea and vision problems.
The device, made by Menlo Park, Calif.-based ev3, should not be used in people with an active infection or who take medication that interferes with clotting, the FDA said.
The U.S. National Institute of Neurological Disorders and Stroke has more information about aneurysms affecting the brain.
Posted: April 2011