FDA Says Edwards Can Start Trial Of CE Marked Valve Technology

In short

Edwards Lifesciences Corporation has received conditional Investigational Device Exemption (IDE) approval from the US FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve.

Background

In another striking demonstration of the different regulatory regimes operating either side of “the pond”, FDA has now allowed a US company to start trialling its new technology… a technology which is already CE marked and hence able to be marketed in Europe.

Edwards’ GLX technology is a proprietary tissue treatment allowing for packaging and sterilisation in a dry condition and 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 program for surgical and transcatheter heart valves, aimed at improving ease of use, facilitating less invasive procedures and simplifying device preparation.

The single arm study will follow standard heart valve guidance and use historical controls. Heart valve trials typically enroll 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.

Company comments

“We are excited about beginning the clinical study of this unique tissue treatment platform in the U.S. 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.”

Source: Edwards Lifesciences Corporation