Healthcare Industry News: U.S. Food and Drug Administration
News Release - August 21, 2017
BioVentrix Announces First Patient Enrolled in IDE Study of the Revivent TC(TM) TransCatheter Ventricular Enhancement Treatment for Ischemic CardiomyopathySAN RAMON, Calif. and CAMBRIDGE, England, Aug. 21, 2017 -- (Healthcare Sales & Marketing Network) -- BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today 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 Revivent TC™ TransCatheter Ventricular Enhancement System; a hybrid closed-chest procedure to treat patients suffering from ischemic cardiomyopathy. BioVentrix received investigational device exemption (IDE) approval for the study from the U.S. Food and Drug Administration (FDA).
The Less Invasive Ventricular Enhancement™ or LIVE™ procedure was performed at Papworth Hospital in Cambridge, United Kingdom by consultant cardiothoracic surgeon Dr. Steven Tsui and consultant interventional cardiologist Dr. Michael O'Sullivan. The device was successfully implanted with three micro-anchor pairs in a 60-year-old patient suffering from ischemic heart failure. The procedure reshaped the left ventricle, decreased the Left Ventricular End Systolic Volume Index (LVESVI), and dramatically increased the Ejection Fraction (EF). Left Ventricular volume reduction has been shown to significantly impact short and long-term survival rates1.
"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," said Dr. Tsui.
"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," said Dr. O'Sullivan.
The ALIVE trial plans to enroll 120 patients at up to 20 sites in the U.S. and U.K. with a primary endpoint analysis at 1 year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, 6 minute walk test, and rehospitalization. Readmission rates following heart failure hospitalization remain high using standard therapies, with ≥ 50% of patients readmitted to hospital within 6 months of discharge. Annually, over 1 million patients are hospitalized with a primary diagnosis of heart failure, accounting for a total Medicare expenditure exceeding $17 billion2.
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 percent3.
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 Desai et al., Rehospitalization for heart failure. Circulation. 24 July 2012 (126:501-506).
3 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.
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