Solitaire FR - A promising new device for acute ischemic stroke treatment

摘要

In March 2012, the U.S. Food and Drug Administration granted approval to ev3/Covidien Vascular Therapies (Irvine, California, USA) to market the Solitaire Flow Restoration (FR) device under 510(k) clearance, making it the third device approved in the United States for recanalization of cerebral vessels in patients with acute ischemic stroke. The Food and Drug Administration approved the Merci retrieval device (Concentric Medical, Mountain View, California, USA), a corkscrew-like wire, in 2004, followed by the Penumbra device (Penumbra Inc., Alameda, California, USA), a combination of a separator and an aspiration catheter, in 2008.