Edwards Lifesciences Corporation (Edwards), announced the first successful clinical use of its new lower-profile Ascendra 2 transapical delivery system. This system is 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.
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 company’s 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.