FDA Expands TAVR Indication to Low-Risk Patients – American College of Cardiology

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for several transcatheter heart valves (Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO) to include patients with severe aortic valve stenosis at low surgical risk. The FDA is the first medical products regulatory body in the world to expand the indication for…

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