BioVentrix Announces First Pre-Clinical Use of Revivent-TC System

December 9, 2015 — BioVentrix Inc. has achieved the first implantation of its micro-anchor heart failure (HF) technology from entirely within the left ventricle (LV) using a catheter-based endovascular approach. This milestone was realized in collaboration with Prof. Louis Labrousse, chief of cardiovascular surgery at Hopital Haut-Leveque in Bordeaux-Pessac France. The pre-clinical study was performed in a previously infarcted ovine model which replicates the scar tissue and anatomy observed in human subjects following a myocardial infarction. The new technology proved it is feasible to identify post-ischemic scar tissue, access the scar from within the vasculature, and deploy Revivent micro-anchors to exclude the diseased tissue without opening the chest.

"The next generation of the Revivent therapy represents a tremendous advancement towards a fully percutaneous volume reduction procedure for heart failure patients. The new system will vastly improve the accuracy of anchor placement and enable a more minimally invasive approach," said Labrousse. He has previously served as principal investigator of numerous other clinical studies seeking to treat patients with the complex challenge of ischemic heart failure.

BioVentrix has shown that the exclusion of scar tissue from the LV cavity in patients suffering from ischemic cardiomyopathy heart failure results in substantial improvements in Quality of Life. This study demonstrates the ability to accomplish the same outcomes with the current hybrid approach. The company anticipates this next-generation system will be utilized in clinical trials in early 2016.

Placement of the Revivent-TC System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a closed-chest, transcatheter approach. The anchors are then pulled toward one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent.

For more information: www.bioventrix.com