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FDA Relies On Short-Term Data To Approve Medtronic's Recapturable TAVR System

This article was originally published in The Gray Sheet

Executive Summary

The approval comes less than a week after FDA approved Edwards' Sapien 3 third-generation transcatheter aortic replacement valve. Both devices were approved based on short-term outcomes data instead of the two-year data FDA has required of TAVR systems in the past.

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