LIVE Procedure Performed in the Netherlands With BioVentrix Revivent TC System

November 21, 2016—BioVentrix, Inc. announced the first clinical use in the Netherlands of its Revivent TC transcatheter ventricular enhancement system. The Less Invasive Ventricular Enhancement, or LIVE, procedure was performed by cardiothoracic surgeon Patrick Klein, MD, and by interventional cardiologist Pierfrancesco Agostoni, MD, at the St. Antonius Hospital in Nieuwegein, the Netherlands.

BioVentrix, which is based in San Ramon, California, received European CE mark approval for the Revivent TC system in June. The device is used for plication of scar tissue after myocardial infarction in ischemic cardiomyopathy patients. The Revivent TC is not approved for sale in the United States. 

According to the company, the Revivent TC device was successfully implanted with four titanium microanchor pairs in a 56-year-old man with ischemic heart failure. The procedure reshaped the left ventricle and decreased the left ventricular end systolic volume index. 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.

In the company’s announcement, Dr. Klein commented, “We are very impressed with the clinical benefits of the Revivent TC system. The patient achieved a 38% reduction in LVESVI. The procedure reduces wall stress and reshapes the left ventricle to improve its pumping efficiency. That is important for treating the underlying cause of heart failure.”

Dr. Agostoni added, “We are excited to be the first center in the Netherlands to implant the Revivent TC system. We achieved a sizeable reduction in the patient's left ventricular volume and he will see significant improvement in his symptoms. The LIVE procedure is clearly less invasive and provides an important sense of control when operating on the beating heart.”

In the transcatheter LIVE procedure, microanchors are placed along the outer surface of the heart and along one of the interior walls. The anchors are then pulled towards 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 30-40%, stated the company.

On May 31, BioVentrix announced that it had received approval from the US Food and Drug Administration for an investigational device exemption to initiate the pivotal ALIVE, the American Less Invasive Ventricular Enhancement clinical trial.