FDA expands approval of Sapien XT transcatheter heart valve

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The FDA expanded the approval of the Sapien XT transcatheter heart valve on March 2 to include pulmonic valve replacement procedures.

Patients with a narrowed pulmonary valve or moderate or greater pulmonary regurgitation caused by congenital heart disease can now use the Sapien XT (Edwards Lifesciences).

Edwards Lifesciences said in a news release that it had already factored the approval into its 2016 financial projections and that the sales for the indication would likely be small.

The expanded approval was based on results of the COMPASSION clinical trial as well as data from Europe, according to Edwards Lifesciences.

The FDA approved the Sapien XT in June 2014 for inoperable and high-risk patients with severe aortic stenosis. In October 2015, the FDA approved the Sapien XT for aortic valve-in-valve procedures.