Clot removal device improves stroke outcome
By Martha Kerr
NEW ORLEANS (Reuters Health) - A device that suctions out blood clots in the brain causing acute stroke proved safe and effective and was associated with improved neurological outcome on all measures, even when used eight hours after the onset of the stroke, according to results of a study.
The mechanical device, known as the Penumbra System and marketed by Penumbra, Inc., of San Leandro, California, helped improve blood flow to the brain in 82 percent of 125 patients studied.
A favorable neurological outcome at 30 days occurred in roughly 42 percent of patients.
The trial results were announced by Dr. Cameron McDougall of Barrows Neurological Institute in Phoenix, Arizona, at the American Stroke Association's International Stroke Conference 2008, held here this past week.
The Penumbra System did not malfunction but there were four adverse procedural events in four patients. At 24 hours, 35 patients (28 percent) had bleeding in the brain.
Death from any cause was 26 percent at 30 days and 33 percent at 90 days.
There was a "high rate" of reopening of previously blocked passageways within blood vessels, McDougall told meeting attendees. "The trend for a better outcome when vessels were opened was consistently observed across all neurological and functional measures," he added.
The Penumbra System has been approved for use in Europe since June 2007 and it just received US FDA approval in December 2007.