BioVentrix's Revivent TC System Achieves 2018 Reimbursement in Germany
February 6, 2018—BioVentrix, Inc. announced that InEK, the German Institute for the Hospital Remuneration System, has reconfirmed the award of NUB Status 1 for the company's Revivent TC transcatheter ventricular enhancement system.
The company stated that the NUB process recognizes select innovative medical devices for reimbursement support in Germany. It enables participating hospitals to receive full reimbursement for the product and a supplemental payment when utilizing groundbreaking technologies not listed in the existing German health care system. Revivent TC achieved this status for the second consecutive year, noted BioVentrix.
Revivent TC is intended for the treatment of heart failure patients who have limited options available to treat their left ventricular dysfunction.
The company received CE mark approval in 2016 for the Revivent TC system for plication of scar tissue in postmyocardial infarction ischemic cardiomyopathy patients. The Revivent TC System is approved for sale in Europe. The device is not approved for sale in the United States.
According to BioVentrix, placement of the Revivent TC System is performed via the less invasive ventricular enhancement (LIVE) procedure. In the LIVE procedure, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a catheter-based approach. The anchors are then pulled toward one another, effectively excluding the scarred and nonfunctioning heart wall. Ventricular volume is immediately reduced by as much as 30% to 40% as a result of the exclusion, stated the California-based company.