Edwards Lifesciences Releases Solid Data from Trial of New Rapid Valve Replacement Technology

An the battle royal in the artificial heart valve replacement market continues. Cardiovascular powerhouses Medronic Inc. and Edwards continue to duke it out.

During this week’s annual meeting of the American Association for Thoracic Surgery (AATS) in Toronto, Canada, Edwards announced three-year clinical outcomes of its Intuity valve platform demonstrating improved cardiac and valvular performance, as well as patient functional status.

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. Intuity, according to the company combines the 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 conventional valves, and enabled more efficient blood flow through the valve.”

At three years, the study reported that rapid deployment aortic valve replacement using Intuity 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 pressure gradient (mean 8.7 mmHg overall); and improved heart function, as demonstrated by a statistically significant reduction in left ventricular (LV) size over time (16 percent reduction in mean LV mass index).

“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 Intuity Elite valve platform currently is 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.

In 2012, Edwards became the first company in the U.S. market with its Sapien heart valve for patients too sick to undergo open heart surgery. Medtronic’s CoreValve followed earlier this year with U.S. Food and Drug Administration approval. The company’s have been working on expanding indications for those products as well as testing new, next-generation catheter-based valve technology.