US-based Edwards Lifesciences has obtained CE Mark approval for its Sapien XT transcatheter heart valve for transcatheter mitral and aortic valve-in-valve procedures.
The Sapien XT transcatheter heart valve provides a minimally invasive treatment option for patients whose surgical mitral or aortic valves require replacement, and who are at extreme risk for surgery.
Edwards Lifesciences is reportedly the only company to obtain a valve-in-valve indication for the mitral position, which addresses an unmet need within the clinical community to provide an alternative to a high-risk surgery.
Edwards Lifesciences’ transcatheter heart valves corporate vice president Larry L. Wood noted 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," Wood added.
The Sapien XT valve is an investigational device in the US being studied as part of the pivotal PARTNER II trial.