BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, has announced the extension of the system’s CE Mark.
Background
Recently covered on our pages with news of promising one year study data, Revivent is a less invasive ventricular remodeling device that aims to reverse the effects of ventricular dilation associated with heart disease. It is the only currently available alternaive to is surgical ventricular remodeling, which is highly invasive.
Less Invasive Ventricular Enhancement, or LIVE™ Therapy, uses the Revivent TC System to exclude scar tissue on the left ventricle so the healthy portion of the heart can operate more efficiently. Micro-anchors 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.
The CE Mark is issued by the European Commission and allows the device to be marketed throughout EU member nations. BioVentrix received its initial CE Mark for the Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure. This has now been extended to May 2024
Company comments
“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,” said Kenneth Miller, President and Chief Executive Officer of BioVentrix. “It ensures that physicians will continue to have an important, less invasive therapeutic option for these patients.”
Source: BioVentrix, Inc.
published: January 23, 2020 in: Cardio, Regulatory