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“Valve-In-Valve” Concerns

This article was originally published in The Gray Sheet

Executive Summary

At the meeting, panel members discussed the safety issue of valve-in-valve implantation, wherein one prosthetic valve is implanted inside another one. This is used occasionally in rescue situations during the transcatheter procedure. Edwards has not conducted any pre-clinical studies to assess safety and performance issues for the valve in this context, and the company stresses that it is not seeking an indication for valve-in-valve use. But FDA is nonetheless concerned that if Sapien becomes commercially available, widespread use of the valve-in-valve technique might occur.
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