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US FDA Approves First Intermediate-Risk Indication For TAVR

 
• By Reed Miller

The expanded indication for Edwards' Sapien XT and Sapien 3 arrives about when the company had predicted.

Edwards Lifesciences Corp. has beaten its rivals to yet another milestone in the development of transcatheter aortic valve replacement (TAVR) systems with the first US FDA-approved indication for intermediate-risk patients.

The agency announced Aug. 18 that it approved an expanded indication for Edwards' Sapien XT and Sapien 3 TAVR systems to include patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery

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