Edwards SAPIEN XT Transcatheter Heart Valve Approved for Pulmonic Valve Replacements
 

Edwards SAPIEN XT Transcatheter Heart Valve Approved for Pulmonic Valve Replacements
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The Food and Drug Administration gave Edwards Lifesciences the green light to offer its Edwards SAPIEN XT transcatheter cardiac valve for pulmonic valve replacements. The device has been approved in the U.S. and Europe for aortic and mitral applications, including valve-in-valve procedures.

The new approval applies to both adult and pediatric patients with a narrow pulmonary valve or severe-e**ugh pulmonary regurgitation due to congenital heart disease.

“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. As risks increase with each open-heart surgery, a **n-surgical option can help them receive treatment, recover and return to **rmal activities sooner,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves, in a statement.

Flashbacks:*Edwards SAPIEN XT Heart Valve **w FDA Approved for Valve-in-Valve Procedures;*Edwards SAPIEN XT Transcatheter Heart Valve FDA Approved;*Edwards SAPIEN XT Approved in Europe for Valve-in-Valve Aortic, Mitral Procedures;*FDA Expands Access to Edwards Lifesciences’ Sapien Heart Valves

Product page: SAPIEN XT…

Source: Edwards Lifesciences

The post Edwards SAPIEN XT Transcatheter Heart Valve Approved for Pulmonic Valve Replacements appeared first on Medgadget.

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