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FDA Approves Two New Indications For Edwards’ Sapien 3 TAVR System

 
• By Reed Miller

Sapien 3 is now indicated to treat failed right ventricular outflow tract conduits, surgical bioprosthetic pulmonary valves and transcatheter aortic valves.

MT2007_Edwards-Commander-Valve_1200.jpg
Edwards' Sapien 3 Valve With The Commander Delivery System • Source: Edwards Lifeseciences

The US Food and Drug Administration has expanded the approved indications for Edwards Lifesciences Corp.’s market-leading transcatheter aortic valves.

On 9 September, the agency announced the approval of a panel-track PMA supplement allowing Edwards to market the Sapien...

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