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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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The first report from the U.S. TVT Registry of transcatheter aortic valve replacement shows procedural and in-hospital outcomes comparable to those seen in randomized trials and international registries.

First PARTNER II Results Show Progress With Edwards’ TAVR Technology

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.

Edwards Wins Approval For Sapien Just In Time For TCT

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