IDE Study Begins for BioVentrix's Revivent TC System for Ischemic Cardiomyopathy
August 21, 2017—BioVentrix, Inc. announced enrollment of the first patient in the international arm of the ALIVE pivotal clinical trial. The trial is designed to demonstrate the safety and effectiveness of the company's Revivent TC transcatheter ventricular enhancement system, which is a hybrid closed-chest procedure to treat patients with ischemic cardiomyopathy.
BioVentrix received investigational device exemption (IDE) approval for the study from the US Food and Drug Administration. The Revivent TC system is not approved for sale in the United States.
The company has received CE Mark certification of the Revivent TC system for plication of scar tissue in ischemic cardiomyopathy patients who have had a myocardial infarction. Placement of the Revivent TC system is performed via the company's Less Invasive Ventricular Enhancement (LIVE) procedure in which 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 no-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion.
The ALIVE trial is expected to enroll 120 patients at up to 20 sites in the United States and United Kingdom with primary endpoint analysis at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life, New York Heart Association class, 6-minute walk test, and rehospitalization.
The initial patient in the trial was treated with the Revivent device using the LIVE procedure at Papworth Hospital in Cambridge, United Kingdom by Consultant Cardiothoracic Surgeon Steven Tsui, MD, and Consultant Interventional Cardiologist Michael O'Sullivan, MD. The device was successfully implanted with three microanchor pairs in a patient who was 60 years of age and had ischemic heart failure. The procedure reshaped the left ventricle, decreased the left ventricular (LV) end-systolic volume index, and dramatically increased the ejection fraction, reported the company.
In the company's announcement, Dr. Tsui commented, "We are pleased to be the first center to implant the Revivent TC system as part of the ALIVE clinical trial. Before the LIVE procedure, this patient's quality of life was severely limited by his heart failure. His treatment options were very limited because of his condition. We hope to provide him with significant clinical benefits by performing this novel procedure which is less invasive and less traumatic than conventional surgical reconstruction."
Dr. O'Sullivan added, "The transcatheter delivery system allows for more ischemic heart failure patients to be treated with reduced procedural risk relative to conventional surgery. Most importantly, this procedure enabled us to achieve a considerable amount of LV volume reduction without the need for open heart surgery or cardiopulmonary bypass."