Edwards gets FDA approval for Sapien 3 Valve Expanded Indication Study

Saturday, January 16, 2016

Edwards Lifesciences Corp. said that the U.S. Food and Drug Administration has approved an expanded indication study of the company's most advanced transcatheter aortic heart valve, the Edwards Sapien 3 valve.

The investigational device exemption or IDE study will enroll elderly patients with severe, symptomatic aortic stenosis (AS) who have been determined by a heart team to be at low risk for mortality if they were to undergo surgical aortic valve replacement.

Patients enrolled in the new PARTNER III Trial will be randomized to receive either the Sapien 3 valve or open surgical valve replacement. Enrollment of about 1,300 patients at up to 50 sites is expected to begin during the second quarter. The trial will also include a 400-patient sub-study using advanced imaging to evaluate leaflet motion in tissue heart valves.

The Sapien 3 valve was approved in the U.S. in 2015 for the treatment of high-risk patients suffering from severe, symptomatic AS.

 

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