Covidien plc (NYSE:COV) won FDA clearance for its Solitaire FR revascularization device for removing blood clots and restoring blood flow in the brains of patients suffering acute ischemic stroke.
The federal watchdog agency cleared the device, which physically removes blood clots from vessels, on the basis of data gathered during Covidien’s Swift study, the first of its kind to compare mechanical interventions for acute ischemic stroke, according to a press release.
The company took a bit of a gamble in March 2011 when deciding to wrap up the Swift trial ahead of schedule with an eye toward speedy market approval, but the measure paid off with news of the FDA’s green light today.
"This new device heralds a new era in acute stroke care," principal investigator Dr. Jeffrey Saver said in prepared remarks. "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."
The Swift studies began recruiting stroke patients in 2010, comparing the Solitaire system against Concentric Medical’s already-cleared Merci Retriever.
In a randomized study of 113 stroke patients at 18 hospitals, the Solitaire system showed a 2.5-fold benefit in restoring blood flow to the brain, a 1.7-fold improvement in post-stroke neurological function and effectively cut mortality rate in half at 90 days, according to a press release.
The company decided to stop enrolling new patients in the study after conferring with members of a Data Safety Monitoring Board, a panel of independent experts that recommended that the company take the trial data to the FDA right away, rather than wait for all 200 of the proposed participants in the study to be treated and tested.
Covidien saw a modest bump on Wall Street today, trading 18 cents higher at $52.14 as of about 12:45 p.m.
The Mansfield, Mass.-based medical products conglomerate acquired Solitaire as part of its $2.6 billion purchase of ev3 Inc. in 2010. The Solitaire device won CE Mark approval in the European Union in July 2009.
Stryker Corp. (NYSE:SYK) acquired rival stroke device maker Concentric in an all-cash $135 million deal in September 2011.