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Getting Set For Sapien: With Data In, Discussion Moves To Adoption Dynamics

This article was originally published in The Gray Sheet

Executive Summary

With all the major clinical data from Edwards Lifesciences' closely watched PARTNER trial now out in the open, there is little doubt among clinicians and industry analysts that transcatheter aortic heart valve replacements will be a U.S. commercial reality in the near term.

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Edwards Reveals Sapien Launch Plans For Transapical Delivery Method

Edwards estimates that the approximately 20%-30% of patients who would otherwise qualify but can’t receive a Sapien valve because their femoral artery is too small would likely make good candidates for the transapical, through the ribcage, route.

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Edwards Lifesciences’ first-to-market transcatheter valve is safe and effective, and its benefits outweigh its risks in an expanded patient population, an FDA advisory panel says.

Two-Year Sapien Data Affirms Durability, And The Importance Of Avoiding Leaks

Mortality rates remained statistically indistinguishable after two years among patients receiving either Edwards Lifesciences’ Sapien transcatheter aortic heart valve or open surgical valve replacement in the firm’s PARTNER trial. Transcatheter aortic valve leaks were highlighted as a primary target for improving survival.

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