BioVentrix Announces First Patient at Cardiovascular Institute of the South Successfully Treated in IDE Study of Revivent TC™ TransCatheter Ventricular Enhancement Treatment
SAN RAMON, Calif., and HOUMA, La., March 12, 2018 /PRNewswire/ -- BioVentrix, Inc., a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced successful treatment of the first patient at the Cardiovascular Institute of the South in 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 heart failure symptoms related to cardiomyopathy. BioVentrix previously received an 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 Terrebonne General Medical Center in Houma, LA by interventional cardiologist Dr. Peter Fail and cardiothoracic surgeon Dr. Donald Netherland. The device was successfully implanted with three anchor pairs in a 58-year-old male patient who suffered a heart attack which resulted in scarring and subsequently developed ischemic heart failure.
"The Revivent TCTM System, as a less-invasive therapy, is a viable solution for patients who suffer from ischemic heart failure. It may provide relief for their symptoms by immediately reducing the volume of their abnormally-dilated heart and also by increasing their ejection fraction. There is no other device on the market that can achieve these significant clinical improvements within a matter of hours. We are very pleased with our first case experience and look forward to being a leader for this technology in the U.S," said Dr. Fail.
"CIS prides itself on being a global leader for utilizing new technologies in the heart failure landscape. We feel that this therapy fills a void in the spectrum of treatment for ischemic patients. A critical parameter to survival for these types of patients is cardiac volume. The LIVETM procedure achieves that by reshaping the left ventricle and excluding the scar from the cavity. Since the procedure is performed via catheters and through a small incision in the chest, more patients can be treated as it greatly reduces the procedural risk," said Dr. Fail.
The ALIVE trial plans to enroll 120 patients at up to 20 sites in the U.S. 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 the hospital within 6 months of discharge. Left Ventricular volume reduction has been shown to significantly impact short and long-term survival rates1. 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 TCTM 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 TCTM TransCatheter Ventricular Enhancement System for plication of scar tissue in post-MI, ischemic cardiomyopathy patients. Placement of the Revivent TCTM System via the LIVETM 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 TCTM System is approved for sale in Europe. It is currently an investigational device in the United States and is not approved for sale.
About Cardiovascular Institute of the South
Founded by Dr. Craig Walker in 1983, Cardiovascular Institute of the South (CIS) is a world-leader in preventing, detecting, and treating cardiovascular and peripheral vascular disease. CIS offers a comprehensive heart and vascular program with expert physicians trained in many specialties, including internal medicine, nuclear cardiology, electrophysiology, lipid management, coronary artery disease, peripheral vascular disease, valve disease, and interventional cardiovascular procedures. CIS has earned international acclaim as a pioneer of research, development and education, as well as an innovator in the treatment of peripheral vascular disease. With a dedicated team of more than 700 team members, CIS provides comprehensive cardiovascular care at 20 locations, eight of which offer telemedicine services, across three states, Louisiana, Mississippi, and Texas. CIS remains at the forefront of technology, providing the highest-quality, compassionate care. This mission has guided the institute for nearly 35 years of excellence. For more information about CIS, call 1-800-425-2565 or visit www.cardio.com.
1White, 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.
2Desai et al., Rehospitalization for heart failure. Circulation. 24 July 2012 (126:501-506).
3Wechsler, 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.