The FDA approved the Intuity Elite valve system (Edwards Lifesciences) for patients undergoing surgical aortic valve replacement.
The device, which is built on the Perimount tissue valve platform, is now available in the U.S. for patients with aortic valve disease. Edwards has sold the device in Europe since 2014.
The FDA’s approval was based on results of the prospective, nonrandomized TRANSFORM clinical trial. The findings were presented in May during a plenary session at the American Association for Thoracic Surgery annual meeting in Baltimore.
The study enrolled 839 low-risk patients at 29 medical centers in the U.S. After one year, 96 percent of patients who were implanted with the Intuity Elite valve system had survived. The valve also reduced the cross clamp times and cardiopulmonary bypass times.