FDA Approves Sapien XT and Sapien 3 for Intermediate-Risk Patients

In a move that extends TAVR to patients with aortic valve stenosis who are less than high risk for surgery, the US Food and Drug Administration (FDA) today approved expanded indications for the Sapien XT and Sapien 3 transcatheter heart valves (Edwards Lifesciences; Irvine, CA) to patients considered at intermediate risk for death or complications associated with surgical valve replacement.

The intermediate-risk indication granted by the FDA allows use of either device in cases where the heart team determines a patient to have a predicted risk of surgical mortality of at least 3% at 30 days, based on the STS risk score and other clinical comorbidities. Prior to today, these devices—and all other transcatheter aortic valves available in the US—were only approved for patients considered at high risk or inoperable.

“This is the first time in the US that a transcatheter aortic valve has been approved for use in intermediate-risk patients,” Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health said in the agency’s announcement of the news. “This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement.”

The expanded indication is based on data from the SAPIEN 3 study, reported in April, which demonstrated both noninferiority and superiority of Sapien 3 to surgical valve replacement at 1 year in a propensity-score analysis of 1,077 intermediate-risk patients with regard to the composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation.

Sapien 3, which was originally approved by the FDA in 2015 for TAVR in high-risk or inoperable patients, features design improvements over the Sapien XT including a skirt intended to prevent paravalvular leak, improved coaxial alignment, and more accurate positioning. 

As a requirement of these approvals, Edwards Lifesciences must conduct a postapproval study to monitor patients through 10 years.

While  the shift toward lower-risk patients is concerning to some TAVR operators—as complications could have a much more substantial impact on quality of life in intermediate-risk patients, who tend to be younger—the transition has seemed inevitable. Mere weeks ago, the CoreValve Evolut R (Medtronic) gained approval for use in intermediate-risk patients with aortic stenosis in Europe, marking the first time a TAVR device was cleared in this group. Additionally, in January the FDA gave the green light for PARTNER III, a study testing Sapien 3 versus surgery in low-risk patients. .




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