CE Mark for EDWARDS INTUITY Elite Valve System Means Small-Incision Surgical Valve Replacement

Cardiovascular device specialist, Edwards Lifesciences Corporation has received CE Mark approval for its EDWARDS INTUITY Elite valve system. The company says its next-generation, rapid deployment system facilitates smaller incisions in surgical aortic valve replacement (AVR) procedures, and is built upon extensive evidence supporting the durability of the Carpentier-Edwards PERIMOUNT heart valve design.

Background

The Intuity Elite valve system combines a unique balloon-expandable frame with Edwards’ proven pericardial Perimount platform, which it says has demonstrated durability up to 25 years in published studies. The new system has design improvements intended to improve ease of use, including a flexible and lower profile delivery system that is designed to facilitate access and visibility through smaller incisions.

The CADENCE-MIS trial, a 100 patient, randomized, controlled, multi-center trial, compared minimally-invasive AVR with the Edwards Intuity valve system to full sternotomy AVR with any conventional bioprosthetic aortic valve. Results were recently presented at the 2014 Annual Meeting of the Society of Thoracic Surgeons (STS). Data showed a statistically significant reduction (24 percent) in ischemic time using minimally-invasive AVR with the Edwards Intuity platform, compared to the full sternotomy approach with conventional bioprosthetic valves. These results are especially meaningful as minimally-invasive approaches have traditionally been associated with longer ischemic times.

Furthermore, the Edwards Intuity valve demonstrated improved blood flow and hemodynamics compared to conventional bioprosthetic valves at 3-month follow-up.

In another study, interim analysis of 158 patients undergoing isolated aortic valve replacement in the prospective, multicenter, single-arm TRITON Trial for the Edwards Intuity platform, found that 55 percent were performed through a minimally invasive approach, as opposed to a full sternotomy, suggesting physicians found the procedure beneficial.

Having gained its CE mark, the system will be made commercially available at hospitals throughout Europe and is supported with favorable reimbursement in Germany as part of diagnosis-related group (DRG) mapping that includes the new category of rapid-deployment aortic valve systems.

Physician comments 

“We’re encouraged by the introduction of heart valve technologies that are developed to facilitate a minimally invasive approach for the improved treatment of patients with aortic valve disease,” said Prof. Michael Borger, M.D., Ph.D., associate director of the Department of Cardiac Surgery at the Leipzig Heart Center in Germany. “Our experience with the Edwards Intuity platform has shown the ability to implant the valve through smaller incisions, with significantly reduced cross-clamp time and improved hemodynamics. This less-invasive, more efficient surgical approach should benefit patients during and after their procedure.”

 Company comments

“We’ve enhanced the Edwards Intuity design to further meet the needs of patients, physicians and hospitals with a valve and procedure that can be readily incorporated into the surgeon’s treatment offerings,” said Donald E. Bobo, Jr., Edwards’ corporate vice president, heart valve therapy. “We believe the Edwards Intuity platform can greatly expand the population of patients who receive the less-invasive approach with important clinical and cost benefits.”

Source: Edwards Lifesciences, Inc.

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