Edwards Initiates PREVAIL TA Study and Completes PARTNER Enrollment

September 8, 2009—Edwards Lifesciences Corporation (Irvine, CA) announced the commencement of enrollment in the PREVAIL TA study with the first successful clinical use of its new lower-profile Ascendra 2 transapical delivery system. PREVAIL TA is a European clinical trial for the Edwards Sapien XT valve and Ascendra 2 system.

According to the company, the Ascendra 2 system is designed to facilitate transcatheter heart valve delivery and deployment with minimal trauma and blood loss. The system's benefits are achieved through a smaller introducer catheter and a more intuitive handle. The Ascendra 2 system has also been optimized for the Edwards Sapien XT valve, which features a new leaflet shape (patterned after the company's surgical valves) and a cobalt-chromium balloon-expandable frame.

The Sapien valve was approved for sale in Europe in late 2007 and has been evaluated as part of nine scientific studies. New clinical data on the Edwards Sapien valve were presented at the Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–26 in San Francisco, the company stated. "Transapical valve replacement can now be achieved in fewer procedural steps as a result of the redesigned delivery system," commented Professor Thomas Walther, MD, who performed the initial procedure at the University of Leipzig Heart Center in Germany.

"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."

On August 31, Edwards Lifesciences announced completion of enrollment in the PARTNER (Placement of Aortic Transcatheter Valves) study of the Edwards Sapien transcatheter heart valve. The company stated that PARTNER is a 1,040-patient, multicenter, randomized, controlled investigational device exemption (IDE) study. The trial assigned patients into one of two arms: a nonsurgical arm, in which the Edwards Sapien valve is compared to nonsurgical treatments, and a surgical arm, in which the device is compared to traditional surgical aortic valve replacement. The primary endpoint for the PARTNER trial is based on 1-year follow-up of each patient enrolled; this evaluation has been underway and is continuing.

"It is exciting that the clinical community will soon have the opportunity to make an informed evaluation of this treatment against conventional therapies that may not be realistic options for high-risk patients with severe aortic stenosis," said Craig Smith, MD, coprincipal investigator for the trial. Investigator Martin B. Leon, MD, added, "The PARTNER trial has brought together multidisciplinary clinical teams aligned around the mission of addressing the serious problem of aortic stenosis by treating patients with a far less invasive transcatheter approach."