BioVentrix announces the 1st Revivent TC™ TransCatheter Ventricular Enhancement procedure in Germany after receiving CE-Mark Certification

San Ramon, Calif., and Hamburg, Germany, December 19, 2016 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first closed-chest Revivent TCTM TransCatheter Ventricular Enhancement System procedure in Germany since receiving CE mark certification. The Less Invasive Ventricular EnhancementTM or LIVETM procedure was performed by interventional cardiologists Dr. Christian Frerker, MD and Dr. Tobias Schmidt, MD and by cardiothoracic surgeon Dr. Ralf Bader, MD at Asklepios Klinik St. Georg in Hamburg, Germany. The St. Georg Heart team is led by Prof. Dr. Karl-Heinz Kuck, who is also the Chairman of the Department of Cardiology and Electrophysiology.


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BioVentrix announces the 1st Revivent TC™ TransCatheter Ventricular Enhancement procedure for Ischemic Cardiomyopathy treatment in the Netherlands

San Ramon, Calif., and Nieuwegein, The Netherlands, November 21, 2016 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first clinical use in the Netherlands of its closed-chest Revivent TC™ TransCatheter Ventricular Enhancement System. The Less Invasive Ventricular Enhancement™ or LIVE™ procedure was performed by cardiothoracic surgeon Dr. Patrick Klein, MD and by interventional cardiologist Dr. Pierfrancesco Agostoni, MD at the St. Antonius Hospital in Nieuwegein, The Netherlands.


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Steven Healy appointed as Chairman of the Board of Directors of BioVentrix, Inc.

SAN RAMON, Calif., October 4, 2016 — BioVentrix, Inc., a pioneer of technologies and procedures for less-invasive treatment of heart failure, today announced that current Board member Steven Healy has been appointed to the position of Chairman of the Board of Directors.


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BioVentrix Receives CE Marking Certification for Revivent TC™, the First Minimally Invasive Heart Failure Treatment to Restore the Left Ventricle

The Revivent TC™ TransCatheter Ventricular Enhancement System enables the treatment and management of patients who suffered a myocardial infarction resulting in left ventricular dysfunction.

SAN RAMON, Calif., June 27, 2016– BioVentrix Inc., an emerging medical device company dedicated to the minimally invasive treatment of heart failure (HF), announced today that it has received certification for CE marking its Revivent TC™ TransCatheter Ventricular Enhancement System. Following a myocardial infarction or heart attack, the Revivent TC™ System implants proprietary micro-anchor pairs to exclude scarred myocardium from the healthy tissue of the left ventricle (LV). The restoration of the LV to a more optimal volume and conical shape has proven to enhance cardiac performance and significantly improve a patient’s quality of life1.


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BioVentrix receives FDA IDE Approval for its Pivotal Clinical Trial, ALIVE

SAN RAMON, Calif., May 31, 2016 – BioVentrix Inc., an emerging medical device company for less invasive treatment of heart failure (HF), today announced that it has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial, named ALIVE (American Less Invasive Ventricular Enhancement). The trial is designed to demonstrate the safety and effectiveness of the Revivent TC™ TransCatheter Ventricular Enhancement System; a hybrid closed-chest transcatheter procedure to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV). This is accomplished by implanting micro-anchoring pairs in the LV to exclude scarred myocardium from the healthy tissue.


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BioVentrix Announces Successful First-In-Man, Catheter-Based Endovascular Clinical Procedure with Revivent-TC™ System for Heart Failure Treatment

SAN RAMON, Calif., and VILNIUS, Lithuania, May 16, 2016 — BioVentrix, a pioneer of technologies and procedures for less-invasive treatment of heart failure (HF), today announced the first-in-man use of its next generation Revivent-TC™ System with an endovascular catheter-based approach from within the left ventricle. The Less Invasive Ventricular Enhancement™ or the LIVE™ procedure, used to reshape and reduce the left ventricle (LV), now utilizes deployment of its micro-anchor technology to exclude scar tissue from within the vasculature and without opening the chest. The device was successfully implanted in a 64-year-old female patient suffering from heart failure symptoms as a result of a myocardial infarction. The procedure was performed by Dr. med. Giedrius Davidavicius, Interventional Cardiologist, and Dr. med. Gintaras Kalinauskas, Cardiothoracic Surgeon, at Vilnius University Hospital in Vilnius, Lithuania.


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BioVentrix announces the 1st Revivent-TC™ TransCatheter Ventricular Enhancement procedure for Ischemic Cardiomyopathy treatment in the United Kingdom

San Ramon, Calif., and Newcastle upon Tyne, United Kingdom, February 18, 2016 — BioVentrix, a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first clinical use in the United Kingdom of its closed-chest Revivent-TC™ TransCatheter Ventricular Enhancement System. The Less Invasive Ventricular Enhancement™ or LIVE™ procedure, utilizing this new TransCatheter approach, is in a clinical trial throughout Western Europe. The TransCatheter procedure reduces excessive volume and reshapes the left ventricle (LV) by pulling the walls of the heart together with its proprietary micro-anchor pair implants. By remodeling the LV to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses patient symptoms. The procedure was performed by interventional cardiologist Prof. Azfar Zaman, Head of Structural Heart Development, and by cardiothoracic surgeon Prof. Stephan Schueler, Head of the LVAD Program, at Newcastle upon Tyne Freeman Hospital in the United Kingdom.


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BioVentrix Announces 30th Clinical Case Milestone for Revivent-TC™ Technology

Adoption of revolutionary, less invasive procedure spreads across Europe

San Ramon, Calif., and Prague, Czech Republic, Dec. 14, 2015 — BioVentrix a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the successful completion of the 30th clinical case using the closed-chest Revivent-TC Ventricular Enhancement System. The hybrid procedure was performed by Prof. Petr Neuzil (interventional cardiologist) and Dr. Ivo Skalsky (cardiothoracic surgeon) on a 38-year-old female patient at the Na Holmoce Hospital in Prague, Czech Republic.


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BioVentrix Announces Milestone Achievement of its First Interventional Heart Failure Procedure for LV Volume Reduction in a Pre-Clinical Model

Study demonstrates feasibility of implantation of its proprietary anchoring technology via a catheter-based approach from within the left ventricle

San Ramon, Calif., and Bordeaux, France, Dec. 4, 2015 — BioVentrix Inc., a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), announced today that it has achieved the first ever implantation of its micro-anchor technology from entirely within the left ventricle using a catheter-based endovascular approach. This milestone was realized in collaboration with Prof. Louis Labrousse, Chief of Cardiovascular Surgery at the world renowned Hôpital Haut-Lévèque in Bordeaux-Pessac France. The pre-clinical study was performed in a previously infarcted ovine model which replicates the scar tissue and anatomy observed in human subjects following a myocardial infarction. The new technology proved it is feasible to identify post-ischemic scar tissue, access the scar from within the vasculature, and deploy Revivent micro-anchors to exclude the diseased tissue without opening the chest


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BioVentrix Releases Results of Revivent™ Impact on Mitral Regurgitation

Retrospective sub-study demonstrates impact of ventricular reshaping on mitral regurgitation patients.

San Ramon, Calif., November 23, 2015 — BioVentrix, announced today that it has completed an analysis of patients with mitral regurgitation who were treated with its Revivent ventricular volume reduction and reshaping technology. The Revivent system is a novel, less invasive therapy designed to treat patients suffering from ischemic cardiomyopathy heart failure. Mitral regurgitation (MR) affects 1.6-2.8 million people in the US1 and is widespread in the ischemic heart failure population. An estimated 40 percent of patients with heart failure have a moderate-to-severe ischemic or functional form of MR which originates from ventricular dysfunction2. Although less invasive therapies are currently utilized to treat the valvular and vascular components of heart failure, no proven therapy exists to address the ventricular origin of ischemic mitral regurgitation. BioVentrix investigated the impact of its Revivent therapy on this patient population in a retrospective sub-study analysis of its broader safety and efficacy trial in 7 EU centers.


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