The US Food and Drug Administration (FDA) has granted a conditional investigational device exemption (IDE) approval to Edwards Lifesciences' new GLX technology platform.
Based on the IDE approval, the company will commence a clinical trial enrolling between 500-700 patients to study its GLX technology applied to a surgical bovine pericardial heart valve.
The GLX technology will initially be studied on the company’s Carpentier-Edwards Perimount Magna Ease Aortic Valve, and the study may be broadened to include other devices.
The primary endpoints of the trial will measure valve safety and effectiveness.
Edwards heart valve therapy vice president Donald Bobo said, "We hope that this study will be the first step towards establishing a new category of high performance heart valves treated with our GLX platform, and laying a foundation for our next generation valve technologies."
The GLX technology is a proprietary tissue treatment platform designed to allow packaging and sterilization of valve in a dry condition, and to provide additional protection for bovine pericardial tissue by enhancing anti-calcification, which could contribute to improved durability.