Edwards Lifesciences won FDA approval for its INTUITY Elite aortic valve replacement system. The device is intended for minimally invasive implantation, even importing some characteristics from the company’s existing transcatheter devices that make the process easier.
Thanks to fewer suturing steps, the new valve helps surgeons implant it faster and speed up other procedures that are done along with the implantation. This can be easier on the patients since shorter procedures, including less time on bypass, may require fewer blood transfusions, better coagulation profile, and easier recovery in the days following.
The device utilizes the firm’s pericardial PERIMOUNT tissue platform that has a solid track record, having been implanted into thousands of patients already on previously available valves.
Some info on what led to the approval, according to Edwards:
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.
Product page: EDWARDS INTUITY Elite…
Source: Edwards Lifesciences…