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University FIRST in Georgia/South Carolina to use lifesaving valve June 26, 2014

Media contact:
Erica C. Cline
Corporate Communications
University Hospital

For immediate release

University Hospital first in Georgia/South Carolina to use lifesaving valve

Wednesday, June 25 (Augusta, Ga.) – University Hospital's multi-disciplinary Structural Heart Clinic, which is the only hospital in the region to perform the minimally invasive Transaortic Valve Replacement, is proud to announce this week that it is the first hospital in Georgia or South Carolina to commercially use the new 29 mm SAPIEN XT Transcatheter Heart Valve from Edwards Lifesciences.

The new Edward SAPIEN XT valve is larger than the traditional Edwards valve, but the new delivery system is smaller, making it better for patients. The Edwards SAPIEN XT transcatheter heart valve was approved by the U.S. Food and Drug Administration (FDA) in June 2014 as a therapy for patients with severe, symptomatic calcific native aortic valve stenosis who have been determined by a Heart Team that includes an experienced cardiac surgeon and cardiologist to be at high or greater risk for open-heart surgery to replace their diseased aortic heart valve. Patients who are candidates for this procedure must not have other conditions that would make them too sick to experience the expected benefit from treating their aortic stenosis (AS). The Edwards SAPIEN XT valve is a collapsible valve that is introduced into the body via a catheter-based delivery system. It replaces a patient’s diseased “native” valve without traditional open-heart surgery and while the heart continues to beat. Its low-profile delivery system was designed to treat a broader population of patients and to reduce major vascular complications.

About the Procedure:

  • The flaps of tissue (valve leaflets) that open and close to regulate the flow of blood in one direction are sewn onto a balloon-expandable cobalt chromium frame.
  • During the procedure, the valve is crimped down to the approximate diameter of a pencil and then delivered into the body via the transfemoral delivery system or transapical and transaortic delivery systems.
  • The delivery systems are designed to allow for controlled, predictable placement of the valve.
  • The valve has a low frame height, similar to the Edwards gold standard surgical valves, designed to respect the cardiac anatomy and minimize the risk of conduction system interference and the need for a permanent pacemaker.
  • The valve’s cobalt chromium frame has high radial strength intended to minimize paravalvular leak.
  • Once in place, the Edwards SAPIEN XT transcatheter heart valve is intended to function like a healthy valve with proper blood flow.



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