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# FDA Expands Approval for Edwards Lifesciences Heart Valve
- URL: https://www.fdaweb.com/fda-expands-approval-for-edwards-lifesciences-heart-valve/
- Published: 2016-03-02T12:00:00.000Z
- Updated: 2026-09-15T02:40:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134950

> FDA has given Edwards Lifesciences expanded approval for its Sapien XT transcatheter heart valve for pulmonic valve replacement procedures. The approval covers treating adult and pediatric patients who suffer from either a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease. Expanded approval was supported by data from the multicenter COMPASSION clinical trial and additional clinical data from Europe, according to the company.  
>  
> The Sapien XT valve was approved by the agency in 2014 for patients at high risk for native aortic valve replacement surgery. In 2015, it was approved for aortic valve-in-valve procedures.