REPORT INDICATES HIGH SUCCESS RATE FOR FDA APPROVED DEVICE USED TO RETRIEVE BLOOD CLOTS IN THE BRAIN

On August 11, 2004, the FDA approved the Merci Retriever made by Concentric Medical Inc. of Mountain View, California (http://www.fda.gov/cdrh/pdf3/k033736.pdf). The device is designed to retrieve blood clots from the brain’s arteries and to open large blood vessels that have become blocked and thereby pose a risk of stroke.

A study published in the July issue of Stroke: Journal of the American Heart Association, reports the device successfully restored blood flow in 48% of the 141 test subjects who had blocked intracranial large blood vessels.
While about 7% of the patients suffered complications, one expert regarded that figure as “probably acceptable for patients with large deficits and poor predictable outcomes.”  This is especially true when the device offers an option for treating patients with no other alternative.

The Merci Retriever is inserted through an artery in the groin and then guided into the brain until it reaches the blood clot. Once the clot is “captured” it is removed along with the device in a lager catheter with a balloon.

Test subjects were not eligible for “clot-busting’ drugs and had the procedure done within 8 hours of the onset of their stroke symptoms.

While the device is a significant step forward in the treatment of ischemic stroke, it should not be regarded as the last word on the subject.

Further advancements should be pursued and now appear to be possible. Technical improvements to the device have already been made and further trials are anticipated.

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