First human cases performed with Edwards Lifesciences’ new transapical heart valve system


Edwards Lifesciences announced on 8 September 2009 the first successful clinical use of its new lower-profile Ascendra 2 transapical delivery system, designed to benefit both patients and physicians by minimising trauma and blood loss, and facilitating transcatheter heart valve delivery and deployment.

The procedures conducted at the University of Leipzig Heart Centre, Germany, 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 Thomas Walther, who performed the first implants with the new Ascendra 2 delivery system. Walther is professor of cardiac surgery and vice chairman at the University of Leipzig Heart Centre, 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 optimised 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.

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.