SAN RAMON, Calif., and BERLIN, May 22, 2017 /PRNewswire/ -- BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first clinical use of its closed-chest Revivent TC™ TransCatheter Ventricular Enhancement System at the Deutsches Herzzentrum Berlin in Germany. The Less Invasive Ventricular Enhancement™ or LIVE™ procedure was performed by interventional cardiologist Dr. Christoph Klein, MD and cardiothoracic surgeon Dr. Felix Hennig, MD with important contributions from Dr. Sebastian Kelle, MD, chief of cardiovascular imaging.
The device was successfully implanted with two micro-anchor pairs in a 52-year-old male patient suffering from ischemic heart failure. The procedure reshaped the left ventricle and decreased the Left Ventricular End Systolic Volume Index (LVESVI). Left Ventricular volume reduction is a common measure of cardiac performance that significantly impacts the short and long-term survival rates. By remodeling the LV to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses patient symptoms.
"We are impressed by the immediate impact of the less-invasive Revivent TC system," said Dr. Kelle. "The patient achieved a 33% reduction in LVESVI and a 15% increase in the Ejection Fraction," continued Dr. Kelle.
"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," said Dr. Klein.
"This patient's quality of life was severely impacted by his heart failure," said Dr. Hennig. "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," continued Dr. Hennig.
About BioVentrix and the Revivent TC System
BioVentrix, a privately held medical technology company headquartered in San Ramon, Calif., is focused on developing and commercializing minimally invasive therapies for treating HF. The company has received CE mark certification for its closed-chest Revivent TC TransCatheter Ventricular Enhancement System for plication of scar tissue in post-MI, ischemic cardiomyopathy patients. 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 catheter-based approach. The anchors are then pulled towards 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 percent1.
Note: The Revivent TC System is approved for sale in Europe; it is not approved for sale in the United States.
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.
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SOURCE BioVentrix Inc.