FDA approves valve for minimally invasive surgical aortic valve replacement
Edwards Lifesciences Corp. announced the FDA has approved a rapid deployment device to help streamline surgical aortic valve replacement for patients with aortic valve disease.
The valve system (Edwards Intuity Elite, Edwards Lifesciences), built on an existing tissue valve platform (Perimount, Carpentier Edwards), draws upon innovations from transcatheter heart valves to facilitate minimally invasive surgery, the company stated in a press release.
“Many patients with aortic stenosis have more than one type of heart disease, most commonly [CAD]. The Edwards Intuity Elite valve system enables surgeons to streamline concomitant procedures, which can be beneficial for patients undergoing these longer, more complex surgeries,” Kevin Accola, MD, program director, Valve Center for Excellence, Florida Hospital Cardiovascular Institute, Orlando, Florida, said in the release.
Data from the TRANSFORM clinical trial of 839 patients in 29 U.S. centers was considered by the FDA in its decision. At 1 year, the valve system was associated with reduced cross-clamp time and cardiopulmonary bypass time, which can lead to decreased mortality and morbidity, reduction in hospital stay and improved NYHA class, the company stated in the release.
Mubashir A. Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery and surgical director of the structural heart program at PinnacleHealth, Harrisburg, Pennsylvania, said in the release that surgery with the valve system “can mean less trauma, early recovery and decreased need for blood transfusion for many patients.”
Disclosure: Accola reports no relevant financial disclosures. Mumtaz reports receiving proctor and consulting fees, honoraria and travel reimbursements from Abbott, Atricure, Edwards Lifesciences and Medtronic.