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.
FDA Expands TAVR Indication To Low-Risk Patients
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.
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