- The Washington Times - Monday, August 16, 2004

ASSOCIATED PRESS

The first device to remove blood clots from the brains of people suffering strokes — a new treatment option that could save lives and shave the $53 billion annual bill to treat strokes — has been approved by the Food and Drug Administration.

The device, the Merci Retriever, threads a tiny corkscrew through an artery to remove the clot and restore blood flow. In 80 percent of strokes, a blood vessel in the brain becomes clogged by a blood clot, increasing the chance of severe disability or death.

Dr. Gary Duckwiler, a University of California at Los Angeles professor and one of the investigators involved in the clinical trial, said 40 percent of patients whose blood clots were successfully removed had positive outcomes.

Dr. Duckwiler said the recovery included instantly regaining the ability to move or speak — while the patient was still in the emergency room.

“I’ve had patients who have had dramatic recovery on the table,” he said. “Our neurologists there, and in the study, were convinced this is going to save lives and save brain function in many patients.”

The device, produced by Mountain View, Calif.-based Concentric Medical, was tested at 25 medical centers across the nation in 141 patients ineligible for a drug that clears clots but must be used within three hours of the stroke.

Dr. Larry Goldstein, director of Duke University’s Center for Cerebrovascular Disease, called the approval “interesting” but added that it remains uncertain how many patients would benefit from the new treatment option.

As part of the patient assessment, a catheter must be inserted through the groin and snaked up the artery for descriptive dye to outline blood vessels and point to obstruction, Dr. Goldstein said. The task requires skilled medical workers.

“It’s not the kind of thing that is capable of being done in any hospital anywhere,” Dr. Goldstein said. “The patient has to have a clot that is not only visible but accessible. That is a major, major limitation to begin with.”

Dr. Duckwiler agreed. But many patients don’t qualify for the current treatment — a clot-busting drug — because too many hours pass before they recognize they’ve had a stroke. Some can’t qualify because they are taking drugs that affect blood clotting.

Dr. Duckwiler said the new device dramatically increases the number of severe stroke victims who now can be treated.

The clinical-trial results were announced Thursday night at the American Society of Interventional and Therapeutic Neuroradiology’s meeting in Boca Raton, Fla., said Dr. Duckwiler, the society’s president.

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