(By Mani) A FDA Advisory Committee will review Edwards Sciences Corp.'s (NYSE:EW) pre-market approval for the Sapien transcatheter heart valve (THV) for use in high risk surgical patients on June 13.
The FDA is expected to focus on the transapical approach, stroke rates, paravalvular leaks/aortic regurgitation (AR), durability, valve-in-valve, and the post-approval study.
The market already expects a favorable outcome and for ultimate approval of Sapien valve along with the transfemoral and transapical delivery systems.
"We too believe the valve will be approved along with the systems, but believe there could be some risk on the timing of the transapical," Deutsche Bank analyst Kristen Stewart wrote in a note to clients.
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Meanwhile, the indication and label will be important given the National Coverage Determination (NCD) The bar was reset higher for the US launch following the results of the first quarter despite the company lowering its guidance to reflect a later than expected push out, as well as the final NCD decision.
The Centers for Medicare & Medicaid Services (CMS) will reimburse transcatheter aortic valve replacement (TAVR) procedures for U.S. patients with symptomatic aortic stenosis under specified criteria.
"We believe there are still some risks to the roll-out and near/medium term sales due to the NCD and the registry requirement," Stewart added.
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In addition, there will be more competition in Europe in the coming year with St. Jude Medical's (NYSE:STJ) expected launch of Portico as well as Medtronic's (NYSE:MDT) next-generation Evolut valve. Boston Scientific is also planning to launch a transcatheter valve, though the system may be less competitive than alternatives based on the data seen so far.