Edwards Lifesciences announced that it has received conditional Investigational Device Exemption (IDE) approval from the FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve.
The single arm study will follow standard heart valve guidance and use historical controls. Heart valve trials typically enrol between 500-700 patients. The GLX technology will initially be studied on the company’s market-leading 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.
“We are excited about beginning the clinical study of this unique tissue treatment platform in the USA with our Magna Ease valve,” said Donald E Bobo, Jr, Edwards’ corporate vice president, heart valve therapy. “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 allowing for packaging and sterilisation in a dry condition, eliminating the need to rinse the valve before implantation. The treatment is designed to provide additional protection for bovine pericardial tissue by enhancing anti-calcification, which could contribute to improved durability. The study is part of a broader development programme for surgical and transcatheter heart valves, aimed at improving ease of use, facilitating less invasive procedures and simplifying device preparation.
GLX received CE mark approval in May 2012. The device is investigational in the USA and not available commercially in this country.