Edwards Lifesciences Corporation has received CE Mark approval for the use of its SAPIEN XT transcatheter heart valve for valve-in-valve procedures, where failing bioprosthetic valves require intervention.
This approval means patients who have already received a bioprosthetic heart valve, which is now failing, and who are considered to be at extreme risk for conventional surgical valve replacement, now have an option available to them.
As well as the aortic valve-in-valve indication, Edwards is the only company to receive approval for use of its valve in the mitral position, which addresses an unmet need within the clinical community to provide an alternative to a high-risk surgery.
“Just as native heart valves experience wear over time, bioprosthetic valves eventually degenerate, too, creating a need for a replacement valve,” said Olaf Wendler*, M.D., Ph.D., professor of cardiac surgery, King’s College Hospital in London, and one of the principal investigators of the SOURCE XT Registry. “The European adoption of valve-in-valve procedures using SAPIEN XT is an important development for treating patients who may otherwise go untreated. In particular, patients needing a re-operation to address a failing mitral valve face a very challenging surgery, and the ability to offer a transcatheter replacement is extremely important for this patient group.”
“The European approval of the SAPIEN XT system for valve-in-valve procedures is a milestone achievement. While this is not a large financial opportunity, it represents an important benefit for patients unable to go through a second open-heart surgery to replace their failing bioprosthetic valves,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves.
*Dr. Wendler provides paid consulting services to Edwards for education, and research and development of transcatheter valve technologies.
Source: Edwards Lifesciences Corporation