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Edwards Lifesciences (EW) said it received approval from the U.S. Food and Drug Administration for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent for patients with severe pulmonary regurgitation.


RTTNews | Dec 20, 2021 09:29AM EST

09:29 Monday, December 20, 2021 (RTTNews.com) - Edwards Lifesciences (EW) said it received approval from the U.S. Food and Drug Administration for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent for patients with severe pulmonary regurgitation.

The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to expand transcatheter therapy options for congenital heart valve disease patients.

The Alterra prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the SAPIEN 3 valve.

Read the original article on RTTNews ( https://www.rttnews.com/3250568/edwards-gets-fda-approval-for-sapien-3-with-alterra-for-transcatheter-pulmonic-valve-replacement.aspx)

For comments and feedback: contact editorial@rttnews.com

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