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Edwards' Sapien Valve: Big Survival Boost In Those Too Sick For Surgery

This article was originally published in The Gray Sheet

Executive Summary

Data from the first-ever randomized trial of a transcatheter aortic heart valve show a substantial one-year survival benefit for Edwards Lifesciences' Sapien versus standard medical therapy, giving the firm major momentum as it prepares to submit one of two upcoming PMAs for the device

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Next-generation Sapien XT transcatheter aortic valve replacement met its non-inferiority endpoint, and showed some procedural advantages over the FDA-approved Sapien device in the latest data from Edwards Lifescience’s TAVR program, presented at the 2013 American College of Cardiology Scientific Sessions in San Francisco.

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