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Devices Interventional Cardiology

 News Release - September 18, 2017

BioVentrix announces the 1st Revivent TC(TM) TransCatheter Ventricular Enhancement procedure for Ischemic Cardiomyopathy treatment at the University Heart Center Zurich in Switzerland

SAN RAMON, Calif., and ZURICH, Sept. 18, 2017 -- (Healthcare Sales & Marketing Network) -- 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 University Hospital Zurich in Switzerland. A team led by Prof. Francesco Maisano, co-director of the University Heart Center of Zurich, and by cardiothoracic surgeon Dr. Alberto Weber, used a new technology to repair a dilated and impaired left ventricle.

The device was successfully implanted with three micro-anchor pairs in a 56-year-old male patient suffering from ischemic heart failure. The procedure reshaped the left ventricle and dramatically decreased the Left Ventricular End Systolic Volume Index (LVESVI). The patient has been discharged from the hospital and is recovering well.

The Less Invasive Ventricular Enhancement™ or LIVE™ procedure serves as an innovative and low-impact method of repairing the damaged left ventricle in ischemic cardiomyopathy patients to improve their symptoms and quality of life. It offers a reliable and less invasive alternative to open heart surgery. Left ventricular volume reduction has been shown to significantly impact short and long-term survival rates1. By remodeling the left ventricle to a more normal shape and size, the implant improves pumping efficiency of the heart, decreases stress of the cardiac wall, and immediately reverses patient symptoms.

"We are impressed by the immediate impact of the Revivent TC system. The patient achieved a 59% reduction in LVESVI and a 38% increase in the Ejection Fraction," said Prof. Maisano. "We are pleased with the outcome of this procedure and look forward to our continued partnership with BioVentrix to offer this therapy to our patients," continued Prof. Maisano.

"This therapy provides a much-needed option for patients suffering from heart failure due to left ventricular anterior scar," said Dr. Weber. "The LIVE procedure is a less invasive therapy which does not require the use of a heart-lung machine. This reduces the impact on the patient and lowers the risk. It expands the patient population that will be able to benefit from this procedure. Now, even patients previously thought to be inoperable can be treated," explained Dr. Weber.

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 percent2.

Note: The Revivent TC System is approved for sale in Europe; it is not approved for sale in the United States.

1 White, HD, et al; Left ventricular end-systolic volume as the major determinant of survival after recovery from myocardial infarction. Circulation; 1987 Jul;76 (1):44-51.

2 Wechsler, 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.


Source: BioVentrix

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