Device Approved to Treat Brain Aneurysm

WEDNESDAY, April 6 (Health Day 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 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% 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.

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Emory neuroradiologists now have a device to treat patients with aneurysms that were once deemed untreatable. A Pipeline Embolization Device (PED) allows Emory nueroradiologists to treat patients with wide neck or giant aneurysms. Until now, aneurysms have been primarily treated by 2 methods: an open surgical procedure or by coiling. But only 15-20% of aneurysms were amenable to these treatments. A cerebral aneurysm is a weak spot in the wall of a blood vessel within the brain, characterized by an abnormal ballooning or widening of the vessel. In the United States, a brain aneurysm ruptures every 18 minutes, and nearly half of these cases are fatal. Of the patients who survive, approximately half will never regain full physical function. The Pipeline Embolization Device (PED) offers patients with wide neck or giant aneurysms a chance to have their aneurysm treated with a minimally invasive, endoscopic procedure. The PED is a metal device, ranging in size from just 10 to 35 mm. Using an endovascular approach, the PED is placed across the neck -- or opening -- the aneurysm with the help of a catheter placed inside the blood vessel. This procedure disrupts blood flow to the aneurysm, causing the blood to clot and, over a period of months, the aneurysm to be reabsorbed by the body. The Emory University Hospital is one of the ten centers where this device has been released and it was the first center in the Southeast to treat a patient under the FDA approval of the PED.
Patient Advantages:

Patients with previously untreatable aneurysms now have a reliable treatment option.

Utilizing a minimally invasive approach means patients heal more quickly and go home a day or two after the procedure. Our center treats the largest volume of patients in the southeast and this experience directly translates into safer procedures and better outcomes.

http://www.emoryhealthcare.org/medicaladvances/neurosciencesetma/pipeline.html