CE Mark Approval Extended for BioVentrix’s Revivent TC LIVE Therapy
January 22, 2020—BioVentrix, Inc. announced the extension of European CE Mark approval for its Revivent TC transcatheter ventricular enhancement system for heart failure to May 2024. BioVentrix received its initial CE Mark in 2016.
In the United States, the Revivent TC system is considered investigational and is not approved for sale. BioVentrix announced in November 2019 that the FDA has granted Breakthrough Device designation status for Revivent TC.
According to BioVentrix, the company’s Less Invasive Ventricular Enhancement, or LIVE therapy, uses the Revivent TC system to exclude scar tissue on the left ventricle due to a heart attack so that the healthy portion of the heart can operate more efficiently. Microanchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has been shown to improve blood flow throughout the body. Positive remodeling of the heart has been shown to improve left ventricular function and heart failure symptoms. The only currently available option is surgical ventricular remodeling, which is highly invasive, noted the company.