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Merci® Retriever Cleared as Clot-Buster

Florida Hospital Neuroscience Institute is the first in state to offer minimally-invasive therapy that could help thousands annually

The first device to remove blood clots from the brains of people suffering strokes has been approved by the US Food and Drug Administration. The Merci® Retriever is a tiny corkscrew threaded through an artery to remove the clot and allow blood flow.

The FDA granted clearance after a thorough review of patient data obtained in a clinical study at 25 medical centers in the United States. Florida Hospital Neuroscience Institute’s Dr. Frank Hellinger, chief of the interventional neuroradiology program, was the only physician in Florida to participate in the clinical trial. The MERCI Trial evaluated the device in 141 patients who were ineligible for a "clot-busting" drug that can only be used within three hours of stroke onset.

Physicians participating in the study navigated the Merci Retriever into the brain using standard catheterization techniques. A small puncture in the groin was used to introduce the Merci Retriever into an artery leading to the brain. Upon reaching the targeted area, the Merci Retriever is designed to restore blood flow by engaging, capturing, and removing the blood clot.

Each year, 700,000 people in the United States suffer a stroke, of those nearly 581,000 suffer from an ischemic stroke.  An ischemic stroke occurs when a blood vessel in the brain is blocked by a blood clot, which can impair brain function and cause severe disability or death.  According to the American Heart Association, stroke killed 163,538 people in 2001 and is the leading cause of serious, long-term disability in the US. It is also the third largest cause of death, ranking behind heart disease and all forms of cancer. Research indicates approximately 500,000 Americans suffer a new stroke each year and 200,000 have a recurrent stroke. By 2050, an estimated one million will have strokes annually.




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