San Ramon, Calif., and Newcastle upon Tyne, United Kingdom, February 18, 2016 — BioVentrix, a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first clinical use in the United Kingdom of its closed-chest Revivent-TC™ TransCatheter Ventricular Enhancement System. The Less Invasive Ventricular Enhancement™ or LIVE™ procedure, utilizing this new TransCatheter approach, is in a clinical trial throughout Western Europe. The TransCatheter procedure reduces excessive volume and reshapes the left ventricle (LV) by pulling the walls of the heart together with its proprietary micro-anchor pair implants. By remodeling the LV to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses patient symptoms. The procedure was performed by interventional cardiologist Prof. Azfar Zaman, Head of Structural Heart Development, and by cardiothoracic surgeon Prof. Stephan Schueler, Head of the LVAD Program, at Newcastle upon Tyne Freeman Hospital in the United Kingdom.
The device was successfully implanted with four micro-anchor 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 (LVESVI) by 25%. This is a common measure of cardiac performance that significantly impacts the short and long-term survival rates with these clinical improvements.
"We are thrilled to be the first center in the United Kingdom to implant the Revivent-TC System," said Prof. Zaman. "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," continued Prof. Zaman.
"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," added Prof. Schueler. "I am pleased to be a part of this medical breakthrough for treating patients with heart failure," continued Prof. Schueler.
About the Revivent-TC System and the LIVE Procedure
Placement of the Revivent-TC System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a closed-chest, TransCatheter approach. The anchors are then pulled toward one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent.1
1Wechsler, A. et al., Clinical benefits twelve months after less invasive ventricular restoration operations without ventriculotomy. Annual meeting of the European Society of Cardio-Thoracic Surgery, 07 Oct. 2013, Vienna, Austria.