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Devices Cardiology

 News Release - March 13, 2017

BioVentrix announces the 1st Revivent TC(TM) TransCatheter commercial procedure to treat Ischemic Cardiomyopathy in China

SAN RAMON, Calif., and XIAMEN, China, March 13, 2017 -- (Healthcare Sales & Marketing Network) -- BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced commercialization and the first clinical use of its closed-chest Revivent TC™ System in the People's Republic of China. The Less Invasive Ventricular Enhancement™ or LIVE™ procedure was performed by Prof. Yan Wang, M.D., Director of the Xiamen Cardiovascular Hospital and his structural heart team in Xiamen, China.

China is one of the largest and fastest growing heart failure markets in the world. This procedure represents the first commercial BioVentrix implant in the Asian market. BioVentrix continues to expand its reach and successfully treat heart failure patients in multiple European countries. It has also recently started enrolling patients in a US FDA-approved pivotal clinical trial.

Three micro-anchor pairs were successfully implanted in a 56-year-old male patient suffering from NYHA class III 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 very excited to be the first center in China to perform the Revivent TC procedure. The patient achieved a 35% reduction in LVESVI and the Ejection Fraction (EF) increased from 25% to 37%," said Prof. Wang. "This was a very positive clinical outcome for this patient which will lead to significant improvement in his quality of life. The Revivent TransCatheter delivery system allows for more ischemic heart failure patients to be treated and reduces the procedural risk compared to other therapy options such as surgical ventricular restoration," continued Prof. Wang. "We have numerous patients that can benefit from this innovative therapeutic option."

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 recently 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.


Source: BioVentrix

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