Aug. 17, 2004 -- A new corkscrew-like device may help clear potentially deadly blood clots and prevent stroke-related deaths and disability.
Yesterday, the FDA approved the Merci Retriever to remove blood clots in the brain that occur in the most common type of stroke, known as ischemic stroke. About 83% of the 700,000 strokes reported annually in the U.S. are caused by blood clots that block blood vessels in the brain.
People with this type of stroke are usually treated with clot-busting drugs, but those drugs are only effective when used within three hours after a stroke begins. The Merci Retriever can be used at any time to clear the blood clot and help restore blood flow to the brain.
The FDA based its approval on a clinical trial conducted at 25 medical centers in the U.S. The study evaluated the safety and effectiveness of the device in 141 people with ischemic stroke who were ineligible to receive clot-busting drugs.
The device is inserted through a hole in the groin, like a catheter, and fed through an artery leading to the brain. When the corkscrew-shaped device reaches the clot, it captures it and removes it from the area.
Researchers say it's the first medical device approved by the FDA to remove blood clots from the brain in people experiencing a stroke.
SOURCE: News release, Concentric Medical.