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Edwards Lifesciences' Sapien XT transcatheter valve

This article was originally published in The Gray Sheet

Executive Summary

Firm's second generation transcatheter aortic heart valve gains European CE mark clearance, along with the NovaFlex transfemoral and Ascendra 2 transapical delivery systems, the firm announces March 2. A "disciplined" European market launch is now beginning for the new valve and size 18-French NovaFlex delivery system, while Ascendra 2 will debut in the second quarter, the company says. "We expect the Sapien XT to help Edwards increase its share of transfemoral procedures in Europe because the XT largely eliminates the smaller size advantage held by Medtronic's CoreValve (both the XT and CoreValve have delivery systems which are about 18-French whereas the prior version of the Sapien was 21-French [or] 23-French, depending on the valve size)," notes Wells Fargo Securities analyst Larry Biegelsen in a same-day report
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