FDA approves Edwards Intuity Elite valve for aortic valve disease - Edwards Lifesciences

Edwards Lifesciences has announced FDA approval of the advanced Edwards Intuity Elite valve system, a rapid deployment device for surgical aortic valve replacement. Built on the trusted PERIMOUNT tissue valve platform and incorporating innovations from transcatheter heart valves, the Edwards Intuity Elite valve system is designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements, thereby offering a cutting-edge treatment option for patients with aortic valve disease. The device is now commercially available.

FDA approval of the Edwards Intuity Elite valve system was supported by data from the TRANSFORM clinical trial, which treated 839 patients in 29 centers in the U.S. The results of this trial were presented recently during a late-breaking session at the American Association for Thoracic Surgery's (AATS) 96th annual meeting.

The data showed that, at one year, the Edwards Intuity valve system is safe and effective and may reduce cross-clamp time and cardiopulmonary bypass time, compared to times recorded in the Society of Thoracic Surgeons' (STS) Adult Cardiac Database. This may provide patient benefits such as decreased mortality and morbidity, less time in an intensive care unit and reduced total hospital stay. Overall, the New York Heart Association (NYHA) Functional Classification, which categorizes patients into one of four groups based on their heart failure symptoms and physical limitations, improved in 73.1 percent of patients at one year.