FDA Approves Two New Indications For Edwards’ Sapien 3 TAVR System
Sapien 3 is now indicated to treat failed right ventricular outflow tract conduits, surgical bioprosthetic pulmonary valves and transcatheter aortic valves.
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FDA Approves Edwards’ Sapien 3 With The Alterra Prestent For Pulmonary Regurgitation
The new device combines Edwards’ market-leading Sapien 3 transcatheter heart valve with its Alterra adaptive prestent device to treat patients with severe pulmonary regurgitation due to congenital valve defects.
Medtronic’s Transcatheter Harmony Valve For Congenital Pulmonary Defect Wins FDA Approval
The Harmony transcatheter pulmonary valve can be used to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation as a result of a congenital malformation of the right ventricular outflow tract.
Edwards Beat Analysts' And Its Own Projections in Q2 As TAVR Volumes Recover
The company recorded $925m in revenue in the second quarter of 2020, exceeding the top end of its previous guidance, and expects to return to growth by the end of the year.