FDA Expands TAVR Indications for Sapien XT, Sapien 3

Patrice Wendling

August 19, 2016

BETHESDA, MA — The US Food and Drug Administration (FDA) has extended the indication for the Sapien XT and Sapien 3 (Edwards Lifesciences) transcatheter aortic valves to include patients at intermediate risk for open-heart surgery[1].

Today's announcement marks the first time in the US that a transcatheter aortic valve has been approved for use in intermediate-risk patients.

Both devices were previously approved only in patients with aortic-valve stenosis who are unable or considered at high risk for conventional surgical valve     replacement.

"This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic-valve replacement," Dr Bram Zuckerman (FDA Center for Devices and Radiological Health) said in the    announcement.

He noted that about a third of patients referred for open-heart surgery for aortic-valve replacement fall into the intermediate-risk category, defined as     having at least a 3% risk of death within 30 days of surgery.

The expanded intermediate-risk indication was based on two studies including data in 2005 intermediate-risk patients treated with the Sapien 3 valve in the PARTNER 2 trial and reported by     heartwire from Medscape in April at the American College of Cardiology     annual meeting.

As part of the Sapien XT and Sapien 3     device approval, the FDA is requiring Edwards Lifesciences to conduct a postapproval study to follow the study participants for 10 years to further monitor     safety and efficacy.

The devices are contraindicated in patients who cannot tolerate blood-thinning medications or who have an infection.

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