FDA OKs Concentric Medical’s Device That Clears Blood Clots
A tiny corkscrew-like device to remove blood clots from the brains of stroke victims won government approval Monday, giving doctors a new treatment option that could save lives and shave the $53-billion annual bill to treat strokes.
In 80% of strokes, a blood vessel in the brain becomes blocked by a blood clot, increasing the chance of disability or death.
The Merci Retriever, produced by Mountain View, Calif.-based Concentric Medical, is threaded through an artery to remove the clot and restore blood flow.
The device, approved by the Food and Drug Administration, was tested at 25 medical centers in 141 patients unable to be treated with a drug that must be used within three hours of a stroke.
The device wasn’t used on smaller blood vessels, about the diameter of human hair. Instead it was tried on major blood suppliers, vessels the size of cooked macaroni. When the vessels are blocked by blood clots, fatality rates can be as high as 90%, said Wade Smith, associate neurology professor at UC San Francisco and the study’s principal investigator.
About 700,000 Americans suffer strokes each year, and 163,538 died of strokes in 2001.
Stroke is the No. 1 ailment to nudge older people into nursing homes, said Dr. Terrence Riley, a neurology professor at the Baylor College of Medicine in Houston.
One patient, an 80-year-old woman, arrived at a Kansas City hospital too late to take the clot-busting drug.
After her blood clot was removed with the Merci Retriever, paralysis reversed and brain scans indicated she was back to normal, said Riley, who was visiting the Kansas City hospital at the time.
“It makes a zealot out of you,” he said.
Dr. Gary Duckwiler, a professor at UCLA who was one of the investigators involved in the clinical trial, said 40% of the high-risk patients whose blood clots were successfully removed had positive outcomes.
Robert Levy, a 57-year-old real estate agent in Marina del Rey, knows the potential payoff. Three years ago, he suffered a stroke as his toddler and her nanny watched.
As video rolled at UCLA, he stared into space when asked to blink. Levy became the second patient to be treated with the Merci Retriever, which snared a blood clot at the base of his brain.
Still on the operating room table, Levy was asked to move his right arm. He obliged. Same for his right leg. A doctor asked his name.
“I said, ‘Robert Levy.’ They were jumping for joy; they were pretty excited,” he said.
