Patients with severe aortic stenosis—a narrowing of the valve that restricts blood flow—who also have other illnesses may be considered to be high-risk for conventional open-heart surgical valve replacement. These patients could benefit from a minimally invasive valve replacement procedure that can be performed without cardiopulmonary bypass or a sternotomy, and has the potential to shorten recovery times.
Using the RetroFlex delivery system, the Edwards SAPIEN transcatheter heart valve is compressed onto a balloon to the approximate diameter of a pencil and threaded through the patient's circulatory system from the leg and expanded securely into place directly over the diseased aortic valve. The Edwards SAPIEN valve can also be used with the Ascendra transapical delivery system, which achieves valve delivery through a small incision between the ribs.
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 evaluates 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.
