Edwards Lifesciences Corporation (NYSE: EW) has announced that it has received CE Mark in Europe for valve-in-valve procedures using the SAPIEN XT transcatheter heart valve, providing a minimally invasive treatment option for patients whose surgical mitral or aortic valves require replacement, and who are at extreme risk for surgery. Edwards is the only company to receive 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.
"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.
More than 300,000 valve replacements are performed worldwide each year through open-heart surgery, utilizing either bioprosthetic tissue valves or mechanical valves. Edwards' proven family of PERIMOUNT bovine pericardial tissue valves have been the world's most frequently implanted valves for more than 30 years, which surgeons have increasingly chosen over mechanical valves, even in younger patients. Patients who receive Edwards' bovine pericardial valves are generally not required to be on lifelong anticoagulation therapy (blood thinners), as they would if they had received a mechanical valve. Decades of clinical experience and peer-reviewed data on Edwards' valves provide robust evidence of long-term performance and optimal hemodynamics of the PERIMOUNT valve platform.
"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." Dr. Wendler provides paid consulting services to Edwards for education, and research and development of transcatheter valve technologies.
In the United States, the SAPIEN XT valve is not commercially available; it is an investigational device being studied as part of the randomized, pivotal PARTNER II Trial.