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Panel Supports Sapien But Urges Cautious Rollout

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences’ Sapien transcatheter aortic valve met widespread expectations last week by gaining support for FDA approval from an agency advisory panel, but the experts urged FDA and Edwards to proceed cautiously.

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Edwards Wins Approval For Sapien Just In Time For TCT

CMS Jumps Out Ahead Of FDA With Transcatheter Valve Coverage Analysis

Edwards Lifesciences is still waiting on an approval decision from FDA on the first indication for its Sapien transcatheter aortic heart valve replacement, but CMS has decided not to wait.

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