Press Releases

SAN RAMON, Calif. –  Febyary 8, 2021 BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter based Ventricular Restoration (TCVR), today announced that the German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 reimbursement designation in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System used in LIVE™ Therapy (Less Invasive Ventricular Enhancement).


 

SAN RAMON, Calif. –  January 6, 2021 – BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that heart failure specialist Jerry Estep, MD, of the Cleveland Clinic has been appointed co-principal investigator of the pivotal ALIVE Trial studying LIVE Therapy using the Revivent TC™ TransCatheter Ventricular Enhancement System. He joins co-principal investigators Gregg Stone, MD, of New York’s Mount Sinai Health System and Andrew Wechsler, MD, of Philadelphia’s Drexel University College of Medicine in overseeing the trial.


San Ramon, CA, USA – October 5, 2020 – BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that Chris Wolff has been named Vice President of U.S. Sales. In this role, Mr. Wolff will be responsible for driving enrollment in the ongoing ALIVE Trial studying the Company’s Revivent TC™ Transcatheter Ventricular Enhancement System, which has reimbursement from the Centers for Medicare and Medicaid Services (CMS).


San Ramon, Calif. – September 2, 2020BioVentrix, Inc., developer of the first hybrid transcatheter device for left ventricular remodeling after a heart attack, today announced that the Company has resumed cases in the pivotal ALIVE Trial studying Less Invasive Ventricular Enhancement, or LIVE™ Therapy, using the Revivent TC™ Transcatheter Ventricular Enhancement System.


REVIVE-HF seeks to demonstrate superiority of the Revivent TC System to current guideline treatment for heart failure

SAN RAMON, Calif.--()--BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced that Ralph Stephan von Bardeleben, MD, of the University Medical Center of Mainz (Germany) has joined the European REVIVE-HF clinical trial of the Revivent TC™ Transcatheter Ventricular Enhancement System as co-principal investigator.


SAN RAMON, Calif. –  February 18, 2020 – BioVentrix, Inc., a pioneer of technologies and procedures for the less invasive treatment of heart failure (HF), today announced that Gregg Stone, MD, of New York’s Mount Sinai Health System has signed on to the pivotal ALIVE Trial of the Revivent TC™ TransCatheter Ventricular Enhancement System as co-principal investigator.


San Ramon, CA – February 6, 2020 – Bioventrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced it received renewal of the highest priority reimbursement in Germany for the Revivent TC™ TransCatheter Ventricular Enhancement System by achieving the NUB Status 1 designation from InEk, the German Institute for Hospital Remuneration.


San Ramon, CA, Nov. 19, 2019 -- BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure.


San Ramon, CA, USA – Oct. 07, 2019 – BioVentrix, Inc. announced the first patient was enrolled and treated in the REVIVE-HF European study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment. 


San Ramon, Calif., February 28, 2019 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced a significant reimbursement achievement. InEk, the German Institute for Hospital Remuneration, has reconfirmed the award of NUB Status 1 for the Revivent TC™ TransCatheter Ventricular Enhancement System.


San Ramon, Calif., and Houma, LA,, March 12, 2018 — 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).


San Ramon, Calif., February 06, 2018 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced a significant reimbursement achievement. InEk, the German Institute for Hospital Remuneration, has reconfirmed the award of NUB Status 1 for the Revivent TC™ TransCatheter Ventricular Enhancement System.


San Ramon, Calif., and Mainz, Germany, April 17, 2017 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced the first image fusion-guided procedure with its Revivent TC system. The procedure, known as Less Invasive Ventricular Enhancement™ or LIVE™, was performed at the Heart Center of the Universitätsmedizin Mainz, a branch of Johannes Gutenberg-University in Mainz, Germany. The senior interventional cardiologists were Ralph Stephan von Bardeleben, MD and Eberhard Schulz, MD. The cardiothoracic surgeon was Walter Kasper-König, MD.


San Ramon, Calif., and Xiamen, China, March 13, 2017 — 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 interventional cardiologist Prof. Yan Wang, M.D., Director of the Xiamen Cardiovascular Hospital and his structural heart team in Xiamen, China.


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.


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.


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.


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.


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 is a privately held medical device company headquartered in San Ramon, CA, USA.

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