Corkscrew Device Retrieves Clots, Quickly Reverses Stroke Damage

NEW STUDY FROM THE 29TH INTERNATIONAL STROKE CONFERENCE

***EMBARGOED UNTIL 11:00 AM ET THURSDAY, FEBRUARY 5, 2004***

Story Summary:

A revolutionary tiny corkscrew that captures blood clots from vessels deep inside the brain can "almost instantly" reverse damage caused by ischemic stroke, according to the first report on the safety and efficacy of the device presented today at the American Stroke Association's 29th International Stroke Conference. Ischemic strokes are caused by a blood clot that blocks blood supply to the brain. Each year, about 700,000 Americans suffer a stroke and 88 percent of those strokes are ischemic, according to the American Stroke Association. Blood clots causing stroke can be dissolved using the FDA-approved clot-busting drug tissue plasminogen activator (tPA) as standard therapy. But, it must be initiated intravenously within three hours (the earlier the better) of stroke onset to be effective.

The investigational device, the Concentric MERCIŽ Retrieval System, restored blood flow in 61 of 114 patients (54 percent) in Phase I and II of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI I /II) trials, which studied patients up to eight hours after initial stroke symptoms who were not eligible for standard tPA therapy, said Sidney Starkman, M.D., professor of emergency medicine and neurology at the University of California, Los Angeles and co-director of the UCLA Stroke Center. Restoring blood flow in these trials reversed paralysis and other stroke symptoms, Starkman said. The MERCIŽ Retrieval System is inserted into an artery in the groin, and then carefully guided via standard angiography into the brain until it reaches the blood clots. Once the device "captures" the blood clot, the device and clot are withdrawn into a larger catheter with a balloon. The retrieval procedure can only be performed by a highly trained team at specialized centers said Starkman Concentric Medical, Inc. of Mountain View, California funded the studies. The Food and Drug Administration is reviewing the device. Log on to www.americanheart.org for more information on stroke.

Soundbites

  • Sidney Starkman, M.D./Professor of emergency medicine and neurology at the University of California, Los Angeles and co-director of the UCLA Stroke Center.
  • Robert Levy/Patient

VIDEO PROVIDED BY: AMERICAN STROKE ASSOCIATION



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