The US Food and Drug Administration (FDA) has cleared Covidien's Solitaire FR revascularization device.
The Solitaire FR device is designed to restore blood flow to the brain in patients suffering from acute ischemic stroke by mechanically removing blood clots from blocked vessels.
The FDA 510(k) application of Solitaire FR device was based on the results of the Solitaire with the intention for thrombectomy (SWIFT) clinical study.
The randomized study, which enrolled 113 stroke patients, was designed to compare the Solitaire FR device with the Concentric Medical’s Merci Retriever device to restore blood flow to the brain.
The results demonstrated that the Solitaire FR device was superior to the Merci Retriever device, a mechanical clot retriever.
Covidien vascular therapies president Stacy Enxing Seng said Solitaire FR provides physicians with another important tool for treating this potentially fatal and often debilitating condition.
The Solitaire FR device has also received CE mark approval and has been marketed internationally by the company since November 2009.