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

Feature | Heart Valve Technology | Jeff Zagoudis, Associate Editor, and Dave Fornell, Editor, Diagnostic and Interventional Cardiology (DAIC)

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.

Read the full article here, FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology | DAIC

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