EU awards CE mark to Revivent Myocardial Anchoring System (BioVentrix) for Heart Failure patients

BioVentrix has received the CE mark for its Revivent Myocardial Anchoring System, a surgical device that offers Heart Failure patients an alternative therapy to surgical ventricular restoration. The Revivent system is comprised of a series of titanium anchor pairs, each consisting of an internal anchor and an external anchor, which are introduced by transmural catheters. Once the desired number of anchor pairs are positioned, a force gauge is used to control apposition, pulling the lateral LV wall toward the septum. This creates a fold of tissue that effectively excludes the non-functioning scar tissue created by a previous heart attack.

The device is curently in a Phase II clinical trial to evaluate the safety and efficacy of its Revivent Myocardial Anchoring System for use in Less Invasive Ventricular Enhancement (LIVE) procedures in patients with heart failure. The trial is under the guidance of Louis Labrousse, Professor of Cardiovascular Surgery, Hopital Haut-L�v�que, Bordeaux-Pessac, France.