The FDA’s Circulatory Devices panel recommended expanded approval for Edwards Lifesciences‘ (NYSE:EW) Sapien heart valve to include a lower-risk group of patients, voting 11-0 in favor of approval with 1 panelist not voting.
The panel recommended approval for the larger patient base despite concerns about the limited clinical data available on long-term side effects of the device, which is the U.S.’s 1st and only aortic valve replacement implant deliverable via catheter.
"A broader indication for high-risk patients would enable multi-disciplinary heart teams to choose the approach best suited to their patients’ needs, including for the first time a transapical delivery option," Edwards chairman & CEO Michael Mussallem said in prepared remarks.
The FDA’s decision on the expanded approval is expected later this year.
The device maker in November 2011 won PMA for the Sapien device for inoperable patients with aortic stenosis, a hardening and narrowing of the aortic valve.
Should the FDA follow the panel’s recommendation, the expanded PMA would include patients who are healthier but still not good candidates for open-heart surgery.
The FDA had also asked the panel to evaluate whether Edwards’ clinical trials in support of Sapien may have been flawed in selecting and classifying patients.
"FDA notes that screening and subsequent enrollment practices were not homogenous. The large variation between the ratios of those screened to those enrolled may represent different selection criteria among sites," according to documents released ahead of today’s meeting. "Enrollment practices related to identification of ‘inoperable’ and ‘high risk’ patients were not homogenous across sites."
EW shares closed 0.3% lower at $90.54 today, but were up 0.7% to $91.13 in after-hour trading as of about 7 p.m.
