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FDA Approves Transcatheter Heart Valve for Pulmonic Procedures
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Edwards Lifesciences Corporation announced that its transcatheter heart valve has received FDA approval for pulmonic valve replacement procedures.
The Sapien XT transcatheter heart valve is now approved for treatment of adult and pediatric patients with congenital heart disease who have a narrowed pulmonary valve or moderate to severe pulmonary regurgitation, according to a company press release.
The new approval was supported by data from the multicenter COMPASSION trial and European studies.
“U.S. approval of the SAPIEN XT valve for pulmonic procedures provides an important, minimally invasive treatment option for a small group of patients who typically face the burden of multiple open-heart surgeries, oftentimes beginning at birth or during childhood,” Larry L. Wood, corporate vice president, transcatheter heart valves, at Edwards Lifesciences Corporation, stated in the release. “As risks increase with each open-heart surgery, a nonsurgical option can help them receive treatment, recover and return to normal activities sooner.”
The Sapien XT valve received FDA approval in 2014 for treatment of high-risk and inoperable patients with severe aortic stenosis. In October 2015, the FDA also approved its use for valve-in-valve procedures.
Disclosure: Wood is an employee of Edwards Lifesciences Corporation.