Covidien touts Brazilian approval for its Solitaire FR revascularization device, designed to restore blood flow to the brain by removing clots from blocked vessels.

Covidien won Brazilian regulatory approval for its Solitaire FR revascularization system as a device to clear blood clots from the brain in patients suffering from acute ischemic stroke.

"Stroke is a widespread public health issue, with approximately 400,000 Brazilians experiencing an acute ischemic stroke annually," Covidien vascular therapies president Stacy Enxing Seng said in prepared remarks. "Solitaire FR is intended to transform the way this potentially fatal and often debilitating condition is treated."

The Solitaire system won FDA clearance in March, and has had CE Mark approval in the European Union since November 2009.

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.

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.

Source: Covidien