Edwards wins extended Sapien TAVI approval, sinks on disappointing Q3
Medical device giant Edwards Lifesciences wins expanded FDA approval to market its Sapien transcatheter aortic valve replacement systems to lower-risk patients, but the nod comes later than expected and depresses the company's full-year outlook.
Edwards Lifesciences (NYSE:EW) won FDA approval to market its Sapien transcatheter aortic valve implantation system to lower-risk patients, despite concerns about limited patient data on the long-term side effects of the device.
The approval came slightly later than expected, spurring the medical device maker to narrow its full-year sales expectations to the bottom of its previous $1.9 billion to $1.97 billion range.
The FDA today approved the Sapien TAVI system for use in patients who are eligible for surgery but who are "at high risk for serious surgical complications or death," according to the FDA notice.