Pressemitteilungen
FDA Grants Breakthrough Device Designation Status for BioVentrix Revivent TC Transcatheter Ventricular Enhancement System for Heart Failure
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. Less Invasive [...]
BioVentrix Enrolls and Treats First Patient in REVIVE-HF European RCT for Ischemic Heart Failure Patients
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. [...]
BioVentrix Announces Study Design for REVIVE-HF: Randomized Controlled Trial (RCT) in Europe
To demonstrate that treatment with the Revivent TCTM System is more effective than Guideline Directed Medical Therapy (GDMT) for the treatment of ischemic heart failure.San Ramon, CA, USA – Sept. 23, 2019 – The Revivent TCTM System has continued to deliver impressive results when evaluating post-market data in Europe. The last 35 consecutive cases [...]
BioVentrix Announces the Appointment of Pedro Marques as VP of Sales in Europe
He will be focused on growth of the Revivent TCTM TransCatheter Ventricular Enhancement System. San Ramon, CA, USA – Sept. 16, 2019 – BioVentrix, Inc., a pioneer of technologies and procedures for the less invasive treatment of heart failure (HF), announced today that Pedro Marques has been named Vice President of Sales for the [...]
BioVentrix Announces Key Additions to Leadership Team
Chief Medical Officer for Europe and Chief Financial Officer named San Ramon, CA, USA – August 6, 2019 – BioVentrix, Inc., a pioneer of technologies and procedures for the less invasive treatment of heart failure (HF), today announced two significant additions to its executive team.Thasee Pillay, MBChB has been named Chief Medical Officer for [...]
BioVentrix Achieves 2019 NUB Reimbursement Status 1 in Germany for Revivent TC™ TransCatheter Ventricular Enhancement System
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.The NUB process [...]
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 — 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 [...]
BioVentrix Achieves 2018 NUB Reimbursement Status 1 in Germany for Revivent TC™ TransCatheter Ventricular Enhancement System
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.The NUB process [...]
BioVentrix announces the 1st image fusion-guided Revivent TC™ TransCatheter Ventricular Enhancement procedure for treating Ischemic Cardiomyopathy
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 [...]
BioVentrix announces the 1st Revivent TC™ TransCatheter commercial procedure to Treat Ischemic Cardiomyopathy in China
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 [...]
BioVentrix Announces NUB Reimbursement Status 1 for Revivent TC™ TransCatheter Ventricular Enhancement System in Germany
San Ramon, Calif., February 6, 2017 — BioVentrix, Inc. a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced that InEk, the German Institute for the Hospital Remuneration System, has awarded NUB Status 1 for the Revivent TC™ TransCatheter Ventricular Enhancement System.The NUB process supports introduction of new [...]
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 [...]
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 [...]
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.Kenneth Miller, President and CEO of BioVentrix said, "We are pleased to have [...]
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 [...]
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 [...]
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, [...]
