The Edwards SAPIEN transcatheter heart valve, available in the U.S. through the PARTNER clinical trial, provides a treatment option for those high-risk patients who are not considered to be good surgical candidates. The transcatheter procedure makes aortic valve replacement possible without open-heart surgery.
Using the Ascendra transapical delivery system, the Edwards SAPIEN transcatheter valve is compressed onto a balloon mounted on a catheter, inserted between the ribs, threaded through the apex of the heart and deployed securely into place directly over the patient's diseased aortic valve. The transapical approach provides an option for patients whose arterial anatomy will not accommodate other transcatheter approaches. The Edwards SAPIEN valve can also be delivered via the femoral artery with the RetroFlex transfemoral delivery system. The transapical and transfemoral approaches provide patient care alternatives.
Hemodynamic Performance
- Leverages Edwards' proprietary bovine pericardial tissue and more than 40 years of continuous refinement in heart valve technology.
Tissue Treatment
- The Edwards SAPIEN transcatheter heart valve incorporates the same tissue manufacturing and ThermaFix* processes used for Edwards' world-class Carpentier-Edwards PERIMOUNT Magna pericardial valves.
- No clinical data are available which evaluate the long-term impact of the Edwards tissue treatment in patients.
Caution: The Edwards SAPIEN transcatheter heart valve, and the RetroFlex and Ascendra delivery systems are investigational devices. Limited by Federal (USA) Law to investigational use. Not available for sale in the United States.
For more information on the U.S. clinical trial please click here.
