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FDA OKs Sapien Valve As Pivotal Trial Control Prior To Marketing Approval

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences says FDA will support use of the firm's investigational Sapien transcatheter aortic heart valve as a control treatment in an upcoming trial of the firm’s next-generation Sapien XT.

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Enrollment in one section of Medtronic's U.S. pivotal study for its CoreValve transcatheter aortic heart valve will be easier now that FDA has granted conditional approval to modify the trial.

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