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.
Sapien late last year won FDA approval specifically in inoperable patients, and the device remains the only TAVI system approved for the U.S. market.
The federal watchdog agency’s decision fell in line with the near-unanimous recommendation of the Circulatory Devices panel, which in June voted 11-0 in favor of expanded approval, with 1 panelist abstaining.
At the time, the panel had considered the FDA’s concerns about whether Edwards’ clinical trials in support of Sapien may have been flawed in selecting and classifying patients, and documents released ahead of the panel meeting questioned the lack of long-term clinical results.
"We note that there are limited data beyond 2 years from the PARTNER trial and the long-term mortality comparison between Sapien THV and open surgery remains unclear," according to FDA documents. "Therefore, the FDA believes that continued long-term follow-up is warranted in a Post-Approval Study (PAS) should this device be approved."
Edwards in turn proposed a pair of post-approval studies tied to expanded approval for Sapien, the 1st being a long-term follow-up of patients remaining in an "Extended Follow-up of Premarket Cohort Study, and the 2nd a non-randomized, prospective registry of new high-risk patients receiving the TAVI implant, according to the report.
News of the expanded approval 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."
Sapien sales amounted to $123.8 million during the 3 months ended September 30, representing a 49.9% bump over the same period last year. Sapien won FDA approval for the U.S. market in November 2011.
Non-U.S. sales of the device slid 8.3% due the impact of foreign currency changes, but grew 4.8% on a constant currency basis. European revenues were particularly hard hit, sliding 17.3% on a non-GAAP basis.
"In [transcatheter heart valves], 3rd-quarter results were impacted by European austerity, and in the U.S., by temporary reimbursement conditions and pronounced seasonality. Despite this shortfall, we anticipate a full year underlying growth rate of approximately 70%," Mussallem said. "With the later-than-anticipated approval of Cohort A, we now expect full-year 2012 U.S. THV sales of $230 million to $240 million and global THV sales of $530 million to $560 million."
Edwards also reported a significant bump in Q3 2012 profits to $69.2 million, or 58¢ per diluted share, representing a 34.1% increase from the $51.6 million, or 43¢ per share, reported for the same period last year.
That was in spite of sliding revenues for every product unit outside of TAVI systems. The company’s surgical heart valves, cardiac surgery systems, total surgical heart valve therapy, critical care vascular and total critical care divisions all saw decreases in the Q3.
EW shares closed 0.7% lower at $86.14 today and lost another 0.2% after hours, trading at $86 as of about 4 p.m.