European Clinical Trial Evaluates BioVentrix's Revivent-TC Ventricular Enhancement System

March 1, 2016—BioVentrix recently announced the first clinical use in the United Kingdom of its Revivent-TC transcatheter ventricular enhancement system as part of a European clinical trial of the company’s Less Invasive Ventricular Enhancement (LIVE) procedure.

The procedure was performed by interventional cardiologist Prof. Azfar Zaman, MD, Head of Structural Heart Development, and by cardiothoracic surgeon Prof. Stephan Schueler, MD, Head of the Left Ventricular Assist Device Program, at Newcastle upon Tyne Freeman Hospital in Newcastle upon Tyne, United Kingdom. The device was successfully implanted with four microanchor pairs in a 62-year-old man suffering from ischemic heart failure. The procedure achieved an approximate decrease of the left ventricular end-systolic volume index by 25%. 

According to BioVentrix, placement of the Revivent-TC system via the LIVE procedure reduces excess volume and reshapes the left ventricle while obviating the need for more invasive surgery. In the procedure, pairs of titanium microanchors are placed along the outer surface of the heart and along one of the interior walls using a transcatheter approach. The anchors are then pulled toward one another, effectively excluding the scarred and nonfunctioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion by as much as 30% to 40%. By remodeling the left ventricle to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses patients' symptoms, noted the company.

The Revivent-TC transcatheter ventricular enhancement system has not received regulatory approval and is not commercially available.

In the company’s press release, Prof. Zaman commented, “We are thrilled to be the first center in the United Kingdom to implant the Revivent-TC system. Patients that suffer from ischemic cardiomyopathy need alternative therapies to treat their heart failure and to improve their quality of life. We are very excited about the outcome of this procedure and believe that this therapy should be strongly considered when evaluating options for treating these types of patients.” 

Prof. Schueler added, “The transcatheter delivery system, which utilizes a combined endovascular approach in conjunction with the interventional cardiologist, allows for more ischemic heart failure patients to be treated and reduces procedural risk from prior therapy options such as surgical ventricular reconstruction. Most importantly, we can achieve significant LV volume reduction without having to open the patient’s chest nor employ cardiopulmonary bypass. I am pleased to be a part of this medical breakthrough for treating patients with heart failure.”