Edwards Lifesciences (NYSE:EW) won FDA approval to market its Sapien transcatheter aortic valve implantation to lower-risk patients, despite concerns about limited patient data on the long-term side effects of the device.
The federal watchdog agency 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.
Sapien late last year won FDA approval only in inoperable patients, and the device remains the only TAVI system approved for the U.S. market.
The news came alongside Edwards’ Q3 financial statement, in which the company reported an 8.5% bump in total revenue, although Sapien sales were slightly disappointing.
"Our 50% growth in transcatheter heart valve sales in the quarter was less than we expected," chairman & CEO Michael Mussallem said in prepared remarks. "Looking forward, we expect a strong close to the year with today’s approval of expanded indications for Sapien, now allowing us to serve many more patients."