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.
The NUB process enables participating German hospitals to receive full reimbursement plus a supplemental payment when utilizing groundbreaking medical technologies not listed in the existing German healthcare system. NUB Status 1 was only assigned to a handful of innovative technologies. This is the fourth consecutive year that the Revivent TC System has achieved this status in 100+ hospitals in Germany.
Achieving the highest possible reimbursement level in Germany again this year demonstrates that the German healthcare system recognizes the impact that the Revivent TC System is having on heart failure patients with few options, said Kenneth Miller, President and Chief Executive Officer of BioVentrix. “We are gratified to not only be able to improve the hearts of patients who need help, but to also do it in a way that improves the economics of treating heart failure.”
Less Invasive Ventricular Enhancement, or the LIVE™ Therapy, uses the Revivent TC System to exclude scar tissue on the left ventricle that has occurred from a heart attack so the healthy portion of the heart can operate more efficiently. Micro-anchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has been shown to improve blood flow throughout the body.1
The company is currently enrolling patients in the REVIVE-HF post-market study in Europe, a randomized, controlled, prospective, multi-center, dual-arm study evaluating the Revivent TC System against Guideline-Directed Medical Therapy. The study is expected to enroll 180 patients. For more information on the REVIVE-HF Trial, please click here.
In the U.S., the company is currently enrolling patients in a pivotal trial of the Revivent TC System, the ALIVE Trial. For more information on the ALIVE Trial, please click here. View a testimonial from a U.S. patient who has received the Revivent TC System here.
BioVentrix is a privately held medical device company headquartered in San Ramon, CA, USA. Its mission is to improve and expand the treatment available for congestive heart failure (CHF) caused by ischemic cardiomyopathy, through the development of less invasive, catheter-based approaches.
Note: The Revivent TC™ System has received the CE Mark and is approved for sale in Europe. It is considered investigational and is not approved for sale in the United States.
1. Stone GW, Selker HP, Thiele H, et al. Relationship between infarct size and outcomes following primary PCI: patient-level analysis from 10 randomized trials. J Am Coll Cardiol 2016;67(14):1674-83.
2. Hamer AW, Takayama M, Abraham KA et al. End-systolic volume and long-term survival after coronary artery bypass graft surgery in patients with impaired left ventricular function. Circulation 1994;90:2899-904.
3. Axelrad JE, Pinsino A, Trinh PN et al. Limited usefulness of endoscopic evaluation in patients with continuous flow left ventricular assist devices and gastrointestinal bleeding. J Heart Lung Transplantation : the official publication of the International Society for Heart Transplantation 2018;37:723-732.
4. Konstam MA, Kramer DG, Patel AR, Maron MS, Udelson JE. Left ventricular remodeling in heart failure: current concepts in clinical significance and assessment. JACC Cardiovasc Imaging 2011;4(1):98-108.
5. Athanasuleas CL, Buckberg GD, Stanley AW et al. Surgical ventricular restoration in the treatment of congestive heart failure due to post-infarction ventricular dilation. J Am Coll Cardiol 2004;44:1439-45.
6. Di Donato M, Frigiola A, Benhamouda M, Menicanti L. Safety and efficacy of surgical ventricular restoration in unstable patients with recent anterior myocardial infarction. Circulation 2004;110:II169-73.
Contacts
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