BioVentrix
BioVentrix is a privately held medical device company dedicated to developing less invasive, catheter-based therapies for treating heart failure caused by ischemic cardiomyopathy. The company focuses on innovative solutions such as the Revivent TC™ TransCatheter Ventricular Enhancement System, which aims to reshape and restore the left ventricle to improve cardiac performance and patient quality of life. With a mission to expand treatment options and improve patient outcomes, BioVentrix develops minimally invasive procedures like the LIVE™ therapy, which excludes scar tissue from the heart to enhance its function.
Industries
Nr. of Employees
small (1-50)
BioVentrix
120 Forbes Blvd., Suite 125, Mansfield, MA 02048 USA
Patents
Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions
US-11903834-B2
View DetailsCardiac tissue penetrating devices, methods, and systems for treatment of congestive heart failure and other conditions
US-11559212-B2
View DetailsCardiac tissue anchoring devices, methods, and systems for treatment of congestive heart failure and other conditions
US-11540822-B2
View DetailsTissue protecting devices for treatment of congestive heart failure and other conditions
US-11529234-B2
View Details
Heart anchor positioning devices, methods, and systems for treatment of congestive heart failure and other conditions
US-11903834-B2
View DetailsCardiac tissue penetrating devices, methods, and systems for treatment of congestive heart failure and other conditions
US-11559212-B2
View DetailsCardiac tissue anchoring devices, methods, and systems for treatment of congestive heart failure and other conditions
US-11540822-B2
View DetailsTissue protecting devices for treatment of congestive heart failure and other conditions
US-11529234-B2
View DetailsProducts
Catheter-delivered ventricular remodeling implant system
A catheter-delivered implant system that places paired anchor components to exclude scarred myocardium and reshape the left ventricle via minimally invasive hybrid or percutaneous procedures.
Catheter-delivered ventricular remodeling implant system
A catheter-delivered implant system that places paired anchor components to exclude scarred myocardium and reshape the left ventricle via minimally invasive hybrid or percutaneous procedures.
Services
End-to-end support for pivotal IDE trials and randomized post-market studies including protocol design, multicenter site initiation, enrollment management, endpoint definition, data collection standards, and preparation for peer-reviewed publication.
End-to-end support for pivotal IDE trials and randomized post-market studies including protocol design, multicenter site initiation, enrollment management, endpoint definition, data collection standards, and preparation for peer-reviewed publication.
Expertise Areas
- Minimally invasive cardiac implant development
- Transcatheter ventricular remodeling and percutaneous endovascular procedures
- Multicenter pivotal and randomized clinical trial management
- Regulatory affairs for medical devices (FDA interactions, Breakthrough Device, CE marking)
Key Technologies
- Transcatheter implant deployment
- Percutaneous endovascular delivery
- Paired anchor implant systems
- CT-to-fluoroscopy image fusion for intraoperative navigation
News & Updates
FDA Breakthrough Device Designation for Revivent TC System
The FDA granted Breakthrough Device Designation status to the Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure, recognizing its potential to address a curable cause of heart failure with a less invasive approach.
CE Mark Extension for Revivent TC System in Europe
The European Commission extended the CE Mark for the Revivent TC™ System, allowing continued market access in Europe until May 2024.
NUB Reimbursement Status 1 in Germany for Revivent TC System
BioVentrix achieved the highest reimbursement status (NUB Status 1) for its Revivent TC™ TransCatheter Ventricular Enhancement System in Germany, supporting its adoption and use in hospitals.
CE Marking Certification for Revivent TC System
BioVentrix received CE marking certification for the Revivent TC™ System, enabling its use in Europe for minimally invasive treatment of heart failure due to myocardial infarction.
FDA Breakthrough Device Designation for Revivent TC System
The FDA granted Breakthrough Device Designation status to the Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure, recognizing its potential to address a curable cause of heart failure with a less invasive approach.
CE Mark Extension for Revivent TC System in Europe
The European Commission extended the CE Mark for the Revivent TC™ System, allowing continued market access in Europe until May 2024.
NUB Reimbursement Status 1 in Germany for Revivent TC System
BioVentrix achieved the highest reimbursement status (NUB Status 1) for its Revivent TC™ TransCatheter Ventricular Enhancement System in Germany, supporting its adoption and use in hospitals.
CE Marking Certification for Revivent TC System
BioVentrix received CE marking certification for the Revivent TC™ System, enabling its use in Europe for minimally invasive treatment of heart failure due to myocardial infarction.