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|Covidien Revascularization Device Receives FDA Clearance|
Solitaire™ FR device mechanically removes blood clots from blocked vessels after a stroke
The Solitaire FR device is intended to restore blood flow to the brain in patients suffering acute ischemic stroke by mechanically removing blood clots from blocked vessels. (Photo: Business Wire)
The Solitaire FR device 510(k) application was based on the results of the Solitaire With the Intention for Thrombectomy (SWIFT) clinical study. In this clinical study comparing two devices, the Solitaire FR device demonstrated superior performance to the Concentric Medical Merci Retriever™ device, a commercially available mechanical clot retriever.
The SWIFT clinical study was the first randomized clinical trial ever conducted on mechanical intervention for acute ischemic stroke. The study randomly assigned 113 stroke patients at 18 hospitals to a procedure to restore blood flow to the brain with either the Solitaire FR device or the Merci Retriever device within eight hours of stroke onset. The Solitaire FR device showed a 2.5x benefit in restoring blood flow to the brain, as determined by a blinded core lab, a 1.7x improvement in post-stroke neurological function and a 55% reduction in mortality at 90 days.
"This new device heralds a new era in acute stroke care," said Dr.
Stroke is a disease that affects the arteries leading to and within the
brain. Ischemic stroke occurs when a blood vessel that carries oxygen
and nutrients to the brain is blocked by a clot. According to the
“This is good news for the approximately 700,000 people each year in the
U.S. who suffer an acute ischemic stroke,” said
The Solitaire FR device received CE Mark approval in
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50191469&lang=en