More questions for LifeStent
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences continues to expect FDA approval of LifeStent for use in the superficial femoral artery by the end of 2008, despite its announcement May 30 that FDA has more questions about preclinical bench testing for the device. FDA sought information on the device's bench testing last fall as well. The company completed the sale of the LifeStent product line in January to C.R. Bard, which now markets the stent in the U.S. for biliary applications, but Edwards maintains responsibility for FDA approval of the femoral artery indication. After approval, Edwards will transition manufacturing responsibilities for LifeStent to Bard (1"The Gray Sheet" Dec. 10, 2007, p. 15)