Oregon Health & Science University will be the first on the West Coast to use a new, self-expanding stent to open clogged brain arteries when it installs the device in two Oregon women this morning.
The stent, manufactured by medical device maker Boston Scientific Corp. of Natick, Mass., is the first device approved by the U.S. Food and Drug Administration for treating ICAD, or intracranial atherosclerotic disease. ICAD is caused by plaque that builds up in the fragile vessels of the brain that triggers a stroke and increases a person's risk for further strokes.
The stent, known as the Wingspan Stent System with Gateway PTA Balloon Catheter, was granted a humanitarian device exemption by the FDA earlier this year. The exemption is given when no comparable device is available to treat or diagnose a disease or condition.
Doctors at OHSU plan to use the stent during two procedures today - one in a 64-year-old Cottage Grove woman, the other in a 65-year-old Molalla woman.
"Both (patients) have had strokes and both of them are failing medical therapy, so this really needs to be done," said Stanley Barnwell, M.D., Ph.D., associate professor of neurological surgery, OHSU School of Medicine and the Dotter Institute, and a member of the Oregon Stroke Center. "Their arteries right now are severely narrowed and what we hope to accomplish tomorrow is to make them look more normal. There's never been a way to open up a brain artery with atherosclerotic disease before." Barnwell is one of four interventional radiologists at OHSU trained to install the Wingspan stent.
OHSU is one of only 10 medical centers in the country trained to use the Wingspan device and will be one of the first five to deploy it.
The procedure involves threading a catheter through an artery to the brain from a small incision in the hip. The catheter is inserted through the blockage, and a balloon is inflated with low pressure to slowly open the clog. The balloon and catheter are removed, and the Wingspan stent is deployed in the "pre-dilated" blockage using a second catheter. The stent has a self-expanding design, which allows it to keep the artery walls open even in curved areas of the vessel.
Until now, the only treatments available have been blood-thinning drugs such as Coumadin, Plavix and aspirin. But they failed to open ICAD blockages in 30 percent of cases. A major NIH study recently found that as many as 22.5 percent of ICAD patients on medical therapy, such as blood-thinning drugs, will go on to have another stroke in the next year.
An estimated 60,000 patients each year suffer a stroke caused by ICAD, and the disease accounts for 8 percent to 10 percent of all ischemic strokes in the United States.
According to the American Stroke Association, about 700,000 people will suffer a stroke this year. It is the nation's No. 3 killer and a leading cause of severe, long-term disability.