• Sapien TAVR Devices Win Expanded Indication May now be used in intermediate-risk patients

    The FDA approved an expanded indication for the Sapien XT and Sapien 3 transcatheter aortic valve replacement (TAVR) systems, making them available to patients at intermediate surgical risk.

    Four months ago, the PARTNER 2 study demonstrated non-inferior event rates for the Sapien XT compared with conventional surgery in this population. A second study involving the Sapien 3 was also conducted. “The two studies demonstrated a reasonable assurance of safety and effectiveness of the Sapien XT and Sapien 3 devices in intermediate risk patients,” the agency said.

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

    Michael J. Mack, MD, of The Heart Hospital Baylor Plano in Texas, called the approval “totally expected” and voiced his support for it. However, “expansion to lower risk should await the results of randomized trials just like inoperable, high and intermediate risk,” he told MedPage Today.

    Edwards Lifesciences is now required by the FDA to conduct a post-approval study with a follow-up of 10 years.

    A competitor, the self-expanding CoreValve Evolut R System, is also anticipated to win FDA approval for the lower-risk population in the near future, having received European clearance earlier this month.

     

    Disclosures

    Mack disclosed serving as co-principal investigator of the PARTNER 3 trial.

     

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details