Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced today the first successful clinical use of its new lower-profile Ascendra 2 transapical delivery system, designed to benefit both patients and physicians by minimizing trauma and blood loss, and facilitating transcatheter heart valve delivery and deployment.
The procedures conducted at the University of Leipzig Heart Centre last week were the first in the PREVAIL TA study, a European clinical trial for the Edwards SAPIEN XT valve and Ascendra 2 system. This system enables valve delivery via a small incision between the ribs.
"Transapical valve replacement can now be achieved in fewer procedural steps as a result of the redesigned delivery system. The enhancements to the Ascendra 2 system make performing the transapical procedure easier and faster, which should result in broader surgeon and patient access to this approach," said Professor Thomas Walther, M.D., Ph.D., who performed the first implants with the new Ascendra 2 delivery system. Prof. Walther is professor of cardiac surgery and vice chairman at the University of Leipzig Heart Centre, Germany, and provides consulting services to Edwards Lifesciences as an educator and trainer for Edwards SAPIEN transcatheter valve procedures.
The system's benefits are achieved through a smaller introducer catheter and a more intuitive handle. The Ascendra 2 system has also been optimized specifically for the Edwards SAPIEN XT valve, which features a new leaflet shape patterned after Edwards' most durable surgical valves and a cobalt chromium balloon-expandable frame.
"The Ascendra 2 system is the result of direct surgeon feedback and close clinical partnership that has resulted in meaningful refinements to the system and procedure. We are proud to lead the advancement of this life-saving technology for high-risk patients with aortic stenosis," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. Working with physicians, Edwards developed the first transapical transcatheter valve delivery system in 2005.
Edwards is the only company to have both transfemoral and transapical transcatheter valve delivery systems commercially available in Europe. The Edwards SAPIEN valve was approved for sale in Europe in late 2007, and has been used in the treatment of thousands of high-risk patients and evaluated as part of nine rigorous scientific studies.
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