First Procedure Performed With BioVentrix's Revivent TC Ventricular Enhancement Device
May 26, 2017—BioVentrix, Inc. announced that the company's Revivent TC transcatheter ventricular enhancement procedure to treat ischemic cardiomyopathy was performed for the first time at Deutsches Herzzentrum Berlin in Berlin, Germany. The Less Invasive Ventricular Enhancement (LIVE) procedure was successfully conducted by interventional cardiologist Christoph Klein, MD, and cardiothoracic surgeon Felix Hennig, MD, with Sebastian Kelle, MD, Chief of Cardiovascular Imaging.
According to BioVentrix, the Revivent TC device was implanted with two microanchor pairs in a 52-year-old man who had ischemic heart failure. The procedure reshaped the left ventricle and decreased the left ventricular end-systolic volume index (LVESVI). By remodeling the left ventricle to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses patient symptoms.
Placement of the Revivent TC system via the LIVE 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 catheter-based 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%, stated BioVentrix.
BioVentrix has received European CE Mark approval for its closed-chest Revivent TC system for plication of scar tissue in post–myocardial infarction, ischemic cardiomyopathy patients. The device is approved for sale in Europe; it is not approved for sale in the United States.
In the company's announcement, Dr. Kelle commented, "We are impressed by the immediate impact of the less-invasive Revivent TC system. The patient achieved a 33% reduction in LVESVI and a 15% increase in the ejection fraction."
Dr. Klein added, "The therapy provides a much-needed option for patients suffering from heart failure due to left ventricular anterior scar, particularly when medical therapy is no longer effective. We are impressed by the immediate improvements and are eager to learn about the long-term results of this promising method."
Also commenting in the BioVentrix press release, Dr. Hennig explained, "This patient's quality of life was severely impacted by his heart failure. Especially for an older and more fragile population, the risks and recovery of surgery often preclude any meaningful intervention. The LIVE procedure eliminates the invasive elements associated with conventional surgical reconstruction. It expands the patient population that will be able to benefit from this procedure."