Edwards Intuity Elite Valve System Receives CE Mark

 

June 3, 2014

June 3, 2014 — Edwards Lifesciences Corp. received CE mark for the advanced Edwards Intuity Elite valve system. The 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.

"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 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."

The next-generation Edwards Intuity Elite valve system combines a unique balloon-expandable frame with Edwards’ pericardial Perimount platform, which 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.

"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., corporate vice president, heart valve therapy, Edwards Lifesciences. "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."

Advanced Innovation for Surgeons and Patients Backed by Clinical Data

Data from 100 patients in the CADENCE-MIS trial, a randomized, controlled, multicenter trial comparing minimally invasive AVR with the Edwards Intuity valve system to full sternotomy AVR with any conventional bioprosthetic aortic valve, were presented at the 2014 annual meeting of the Society of Thoracic Surgeons (STS).

The trial found:

  • Minimally invasive AVR with the Edwards Intuity platform demonstrated a statistically significant reduction (24 percent) in ischemic time (the amount of time blood flow to and from the heart is stopped during surgery) 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; and
  • Improved blood flow and hemodynamics with the Edwards Intuity valve compared to conventional bioprosthetic valves at three-month follow-up.


Additionally, an 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.

The system is currently being studied as part of the TRANSFORM trial, the first U.S. clinical trial of a rapid deployment system for surgical aortic valve replacement. It is an investigational device and not yet available for sale or use in the United States. The system will be 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.

For more information: www.edwards.com

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