EDWARDS INTUITY Elite Valve System Receives CE Mark

IRVINE, CA--(Marketwired - Apr 4, 2014) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received CE Mark for the advanced EDWARDS INTUITY Elite valve system. This 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 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."

The next-generation EDWARDS INTUITY Elite valve system combines a unique balloon-expandable frame with Edwards' proven 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., 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."

Advanced Innovation for Surgeons and Patients Backed by Robust Clinical Data
Data from 100 patients in the CADENCE-MIS trial, a randomized, controlled, multi-center trial comparing minimally-invasive AVR with the EDWARDS INTUITY valve system to full sternotomy AVR with any conventional bioprosthetic aortic valve, were recently presented at the 2014 Annual Meeting of the Society of Thoracic Surgeons (STS). The trial found: