June 23, 2014 — Edwards Lifesciences Corp. announced that three-year clinical outcomes of its Edwards Intuity valve platform demonstrated improved cardiac and valvular performance, as well as patient functional status.
These new data from the TRITON(1) trial were presented at the American Association for Thoracic Surgery’s (AATS) 94th annual meeting in Toronto by Thorsten Wahlers, M.D., Ph.D., Hospital and Health Center for Heart and Thoracic Surgery, University Clinic, Cologne, Germany.
The interim analysis of 287 patients who underwent aortic valve replacement with Intuity included 138 that received the next-generation Intuity Elite rapid-deployment valve. The platform combines the proven Carpentier-Edwards Perimount design with a balloon-expandable, cloth-covered frame, which enables the use of fewer sutures during valve replacement surgery.
"There is evidence from our experience that the expansion of the frame during valve implantation can potentially widen and reshape a narrowed left ventricular outflow tract, which directs blood flow into the aortic valve. This patient benefit was demonstrated in our study through clinically significant reductions in aortic valve mean pressure gradient and left ventricular size," said Wahlers. "This design element also helped clinicians better select a valve size most appropriate for the patient, which can be a challenge with conventioal valves, and enabled more efficient blood flow through the valve."
At three years, the study reported that rapid deployment aortic valve replacement using the Edwards Intuity valve platform in patients with aortic stenosis was associated with beneficial outcomes, including:
- Statistically significantly hemodynamic performance improvement of the bioprosthetic valve, as indicated by a low aortic valve (AV) pressure gradient (mean 8.7 mmHg overall); and
- Improved heart function, as demonstrated by a statistically significant reduction in left ventricular size over time (16 percent reduction in mean LV mass index).
"We are pleased that these data demonstrated important advantages that were meaningful for patients, which is significant given that the Edwards Intuity valve platform is built on the proven Carpentier-Edwards Perimount heart valve design and represents a new procedural approach to aortic valve surgery. We are continuing our launch of the Edwards Intuity Elite valve in Europe, to provide a new treatment option for surgeons that is built on a surgical valve platform they trust," said Donald E. Bobo Jr., Edwards' corporate vice president, heart valve therapy.
The Edwards Intuity Elite valve platform is currently being studied as part of the TRANSFORM trial, the first U.S. clinical trial of a rapid deployment aortic valve replacement. It is an investigational device and not yet available for sale or use in the United States.
For more information: www.edwards.com