FDA approval for Edwards Intuity Elite rapid deployment valve


Edwards Lifesciences has received FDA approval for its advanced Intuity Elite rapid deployment valve for surgical aortic valve replacement. A press release reports that built on the trusted Perimount tissue valve platform and incorporating innovations from transcatheter heart valves, the 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 valve, the press release states, was supported by data from the TRANSFORM clinical trial, which treated 839 patients in 29 US centres. 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 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 categorises patients into one of four groups based on their heart failure symptoms and physical limitations, improved in 73.1% of patients at one year.

Kevin Accola (Valve Center for Excellence at the Florida Hospital Cardiovascular Institute, Orlando, USA) says: “Many patients with aortic stenosis have more than one type of heart disease, most commonly coronary artery disease. The Edwards Intuity Elite valve system enables surgeons to streamline concomitant procedures, which can be beneficial for patients undergoing these longer, more complex surgeries.”