BioVentrix’s Revivent TC Ventricular Enhancement System Receives CE Mark Approval
June 27, 2016—BioVentrix Inc. announced that it has received European CE Mark approval for its Revivent TC transcatheter ventricular enhancement system. Revivent TC system is used after a myocardial infarction to implant microanchor pairs to exclude scarred myocardium from the healthy tissue of the left ventricle (LV). The restoration of the LV to a more optimal volume and conical shape has proven to enhance cardiac performance and significantly improve a patient's quality of life, noted the company.
According to BioVentrix, the Revivent TC system and its placement with the LIVE (Less Invasive Ventricular Enhancement) procedure obviates the need for more invasive surgery. In the procedure, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a closed-chest endovascular approach. The anchors are then pulled toward one another, effectively excluding the scarred and nonfunctioning heart wall. As a result of the exclusion, ventricular volume is immediately reduced by as much as 30% to 40%.
At 2-year follow-up, patients demonstrated a 38% improvement in quality of life. Additionally, treatment has been shown to extend life for patients with a significant reduction of 31% in LV end-systolic volume index and a 23% improvement in LV ejection fraction, stated BioVentrix.