Study demonstrates feasibility of implantation of its proprietary anchoring technology via a catheter-based approach from within the left ventricle
San Ramon, Calif., and Bordeaux, France, Dec. 4, 2015 — BioVentrix Inc., a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), announced today that it has achieved the first ever implantation of its micro-anchor technology from entirely within the left ventricle using a catheter-based endovascular approach. This milestone was realized in collaboration with Prof. Louis Labrousse, Chief of Cardiovascular Surgery at the world renowned Hôpital Haut-Lévèque 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 Prof. 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.
“This is a significant and exciting step in the progressive evolution of the BioVentrix technology. The company continues to innovate its ground breaking therapy for less invasive LV volume reduction in heart failure patients with the goal of achieving a completely percutaneous approach. It reaffirms the company’s commitment to extend this therapy to a wider range of heart failure patients who are suffering from ischemic cardiomyopathy. ” added Dr. Ryan A. Brown, M.D., BioVentrix Vice President of Medical Affairs.
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 Life1. 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.
About the Revivent-TC System and the LIVE Procedure
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 percent2.
1Wechsler, A. et al., Clinical benefits twelve months after less invasive ventricular restoration operations without ventriculotomy. Annual meeting of the European Society of Cardio-Thoracic Surgery, 07 Oct. 2013, Vienna, Austria.