"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 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.