-- Scott Roberts
WEDNESDAY, April 6 (HealthDay News) -- 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
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
The device, made by Menlo Park, Calif.-based ev3, should not be
used in people with an active infection or who cannot 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.
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