FDA Expands TAVR Indication To Low-Risk Patients

The US Food and Drug Administration announced on 16 August that it has approved PMA supplements to add low-risk patients to the approved indication for transcatheter aortic valve replacement (TAVR) systems marketed by Medtronic PLC and Edwards Lifesciences Corp.

Edwards’s Sapien 3 and Sapien 3 Ultra balloon-expandable TAVR valves and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO self-expanding TAVR valves are now indicated as an alternative to open-heart valve surgery for treatment of severe symptomatic aortic valve stenosis, even if the patient would be at low risk for death or major complications in open-heart surgery