Covidien Revascularization Device Receives FDA Clearance

Covidien Plc has received U.S. Food and Drug Administration clearance for its Solitaire FR revascularization device, which is is intended to restore blood flow to the brain in patients suffering acute ischemic stroke by mechanically removing blood clots from blocked vessels.

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 Merci Retriever device, manufactured by Mountain View, Calif.-based Concentric Medical, Covidien officials claim.

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 2.5 times the benefit in restoring blood flow to the brain, as determined by a blinded core lab, a 1.7 time improvement in post-stroke neurological function and a 55 percent reduction in mortality at 90 days.

“This new device heralds a new era in acute stroke care,” said Dr. Jeffrey L. Saver, the SWIFT study’s principal investigator and a professor of neurology at the David Geffen School of Medicine at Universityof California Los Angeles. “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.”

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 American Heart Association, stroke is the fourth leading cause of death in the U.S. and a leading cause of long-term disability.

“This is good news for the approximately 700,000 people each year in the U.S. who suffer an acute ischemic stroke,” said Stacy Enxing Seng, president of Covidien’s Vascular Therapies unit. “Solitaire FR provides physicians with another important tool for treating this potentially fatal and often debilitating condition.”

The Solitaire FR device received CE Mark approval in Europe and has been commercialized internationally by Covidien since November 2009. The Solitaire FR device will be available in the U.S. in April.

U.S. headquarters for Covidien are in Mansfield, Mass.