March 5, 2012—Covidien (Mansfield, MA) announced that the US Food and Drug Administration has granted 510(k) clearance for the company’s Solitaire FR revascularization device, intended for blood flow restoration to the brain in patients with acute ischemic stroke by mechanically removing blood clots from blocked vessels.
According to the company, the 510(k) application for the Solitaire FR device was based on the results of the SWIFT (Solitaire With the Intention for Thrombectomy) clinical study. In this comparison of two devices, the Solitaire FR device demonstrated superior performance to a commercially available mechanical clot retriever (Merci Retriever, Concentric Medical, Inc., recently acquired by Stryker Corporation, Kalamazoo, MI).
The SWIFT study randomly assigned 113 stroke patients at 18 hospitals to undergo clot removal with either the Solitaire FR or the Merci Retriever within 8 hours of stroke onset. The Solitaire FR showed a 2.5-times benefit in restoring blood flow to the brain, as determined by a blinded core lab; a 1.7-times improvement in poststroke neurological function; and a 55% reduction in mortality at 90 days, stated Covidien.
The SWIFT data were presented by Principal Investigator Jeffrey L. Saver, MD, at the International Stroke Conference in New Orleans, Louisiana, as previously reported in Endovascular Today.
“This new device heralds a new era in acute stroke care,” commented Dr. Saver. “We are going from our first generation of clot-removing procedures, which were only moderately good in reopening target arteries, to now having a highly effective tool. This really is a game-changing result.”
Covidien advised that the Solitaire FR device will be available in the United States in April 2012. The device received CE Mark approval in Europe and has been commercialized internationally by Covidien since November 2009.
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