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Medicare Now Covering TAVR for Low Risk Patients

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  • Medicare Now Covering TAVR for Low Risk Patients

    FDA expands indication for TAVR to low-risk patients

    The FDA has expanded its indication for transcatheter aortic valve replacement (TAVR) to low-risk patients, the agency announced August 16, approving a handful of valves for an intervention that was previously limited to intermediate- and high-risk patients.

    Among the valves that received premarket approval were Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO. Up to this point, the standard of care for low-risk aortic valve replacement candidates was open-heart surgery, and the FDA said in its statement that it’s the first regulatory body in the world to expand the indication for TAVR to patients at a low risk for death or major complications during such surgeries.
    My TAVR has been dropped from the trial and will be paid for by medicare - same valve, same interventional cardiologist, same date, same hospital.

    Another good article with more info on benefits.

    FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology

    August 16, 2019 — In one coordinated move, the U.S. Food and Drug Administration (FDA) opened use of transcatheter aortic valve replacement (TAVR) to low-risk patients today. The FDA simultaneously expanded the indications for use for both the Edwards Lifesciences’ Sapien 3 valve and Medtronic’s CoreValve Evolut system for this patient population. The low-risk patient population is the final surgical risk category to be approved for TAVR, a minimally invasive alternative to open-heart surgical valve replacement (SAVR), and includes patients who may be younger and more active than higher-risk patients. Both devices are indicated for patients with severe, symptomatic aortic stenosis (AS).

    The expanded FDA indication was widely anticipated because of excellent clinical trial results. Clinical trial data to date for both the CoreValve and Sapien 3 have been outstanding, performing as well, or better, than SAVR in high-risk, intermediate-risk and low-risk patients. The approved use in low-risk patients paves the way for an even more rapid expansion, as experts widely expect the transcatheter-based procedure to begin replacing a large swath of surgical valve replacement volume in the next couple years.
    Last edited by rich; 08-19-2019, 10:44 AM.