Edwards Lifesciences has announced its transcatheter heart valve—Sapien XT—has received CE-mark approval to be used in valve-in-valve procedures for the both the aortic valve and the mitral valve in patients who are at extreme risk for surgery. The company is the only company to receive a valve-in-valve indication for the mitral position.
“Just as native heart valves experience wear over time, bioprosthetic valves eventually degenerate, too, creating a need for a replacement valve,” says Olaf Wendler, King’s College Hospital in London, UK, and one of the principal investigators of the SOURCE XT Registry. He adds: “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.”
As well as receiving CE-mark approval for the Sapien XT to be used in valve-in-valve procedures, Edwards Lifesciences recently received CE-mark approval for its transcatheter aortic valve implantation (TAVI) device Sapien 3.
According to a press release, the Sapien 3 valve builds upon Edwards’ decades of experience in the development of tissue heart valves, and the proven benefits of the company’s Sapien valves. The new valve has an outer skirt, providing a seal to address paravalvular leak. The effectiveness of this solution is supported by the limited clinical experience, as detailed in two first-in-human feasibility studies, which demonstrated that significant paravalvular leak was eliminated TAVI.
The press release reports that valve is the only commercial transcatheter heart valve that can be delivered through a low-profile 14 French expandable sheath, which has shown through early clinical experience a low rate of complications. Sapien 3 can be implanted through multiple approaches: transfemoral, transapical or transaortic.