BioVentrix announced today that it received an extension of its CE Mark for the Revivent TC transcatheter ventricular enhancement system for heart failure.
The extension of the initial CE Mark approval BioVentrix won in 2016 allows the device to be marketed throughout European Union member nations until May 2024, according to a news release.
BioVentrix’s Revivent TC system is designed to exclude scar tissue on the left ventricle that has occurred from a heart attack so that the healthy portion of the heart is able to function more efficiently. The heart is remodeled to a more normal shape and size with reduced wall stress using implanted micro-anchors.
Currently, BioVentrix is enrolling up to 120 patients at up to 20 U.S. sites with a primary endpoint analysis at one year for its Alive pivotal trial of the Revivent TC system. The system is already commercially available in Europe. The Revivent TC system also won FDA breakthrough device designation in November 2019.
“The extension of our CE Mark is not only an important milestone for the company, but also validates the need for a novel therapy for patients with left ventricular dysfunction who are among the estimated 10 million people in the European Union suffering from heart failure,” BioVentrix president & CEO Kenneth Miller said in the news release. “It ensures that physicians will continue to have an important, less invasive therapeutic option for these patients.”