Solitaire FR revascularisation device receives FDA clearance


The Food and Drug Administration (FDA) has given clearance to ev3 / Covidien for its Solitaire FR revascularisation device which is intended to restore blood flow to the brain in patients suffering acute ischaemic stroke by mechanically removing blood clots from blocked vessels. 

The Solitaire FR device 510(k) application was based on the results from the SWIFT (Solitaire with the intention for thrombectomy) clinical study. The purpose of the study was to demonstrate substantial equivalence of the Solitaire device with the commercially available mechanical clot retriever, the Merci Retriever (Concentric Medical), as well as to demonstrate safety and efficacy of the Solitaire device in subjects requiring mechanical thrombectomy diagnosed with acute ischaemic stroke.

The results of the study show that the Solitaire FR device opened blocked vessels without causing symptomatic bleeding in or around the brain in 61% of patients, compared to 24% of cases performed with the Merci Retriever. The use of the Solitaire also led to better survival three months after a stroke. There was a 17.2% mortality rate with the new device, compared with a 38.2% rate with the Merci Retriever as presented by Jeffrey L Saver, Stroke Center director, University of California, Los Angeles, (UCLA), USA, at the American Stroke Association’s International Stroke Conference 2012.

“This new device heralds a new era in acute stroke care,” said Jeffrey L Saver, the SWIFT study’s principal investigator. “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 Solitaire FR device received CE mark approval in Europe and has been commercialised internationally by Covidien since November 2009. According to a company release, the Solitaire FR device will be available in the USA in April.

About the SWIFT clinical study

The SWIFT clinical study was the first randomised clinical trial ever conducted on mechanical intervention for acute ischaemic 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.