BioVentrix, Inc., developer of the first less invasive system for left ventricular remodeling, today announced online publication of positive one-year results from its CE Mark study of the Revivent TC„¢ System in the European Journal of Heart Failure. The paper will be published in print in the January issue of the journal.
Authors of the study, entitled Less Invasive Ventricular Reconstruction for Ischemic Heart Failure concluded, Treatment with the Revivent TC System in patients with symptomatic heart failure results in significant and sustained reduction of left ventricular (LV) volumes and improvement of LV function, symptoms, and quality of life.
They added, The ability to achieve these results without the need for sternotomy or cardiopulmonary bypass is an important advance for the treatment of patients suffering from ischemic cardiomyopathy heart failure.
The prospective, multicenter, single-arm study of 89 patients at 22 centers in 12 countries in the European Union was designed to evaluate the efficacy and safety of the Revivent TC System for scar exclusion in the heart, volume reduction, and reshaping of the LV in selected patients with ischemic cardiomyopathy (enlarged and weakened left ventricle with reduced capacity to pump blood after a heart attack). Of the 86 patients successfully treated with the system, 51 patients received delivery via a sternotomy and 35 were treated using a less invasive, hybrid approach without sternotomy. None of the patients treated in this trial required cardiopulmonary bypass to implant the device.
The study showed the following patient outcomes at 12 months:
- 100% of patients demonstrated significant and sustained reduction in LV volumes
- 27% reduction in LVESVI (74 ± 28 ml/m²BSA vs 54 ± 23 ml/m²BSA, P<0.001)
- 24% reduction in LVEDVI (106 ± 33 ml/m²BSA vs 80 ± 26 ml/m²BSA, P<0.0001)
- 16% improvement in LVEF (29 ± 8% vs 34 ± 9%, P<0.005)
- 90.6% survival
- 27% improvement in New York Heart Association (NYHA) functional class (average class of 2.6 vs. 1.9) “ 59% of subjects were NYHA class III at baseline; at one year, 79.4% were class I or II
- 36% improvement in quality of life as measured by the Minnesota Living with Heart Failure questionnaire (MLHF) (41 vs. 27 points, p<0.001)
- 18% improvement in exercise capacity as measured by the Six Minute Walk Test (6MWT “ 342 meters vs. 403 meters, p<0.001))
- 50% improvement in average mitral regurgitation (MR) grade in the 68 patients who entered study with measurable functional MR (FMR) of at least grade 1+ at six months (1.12 vs. 0.57) and 24% improvement at 12 months (1.12 vs. 0.86)
- 97% procedural success
- Median length of hospital stay was 14 days; however, subsequent post-market study has seen length of stay decrease substantially as implanters gain more experience
Percutaneous coronary intervention (PCI), which implants a stent, is considered the standard of care for restoring blood flow to the heart after a heart attack. However, 50 percent of patients treated with PCI still develop large LV scars,1 which cause the heart to dilate. Enlarged LVs are associated with more severe heart failure symptoms, higher mortality and more frequent re-hospitalization.2,3,4 Positive remodeling of the heart has been shown to improve LV function and heart failure symptoms.5,6 The only currently available option is surgical ventricular remodeling, which is highly invasive.
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.
About the Revivent TC System
Less Invasive Ventricular Enhancement, or the LIVE „¢ procedure, uses the Revivent TC„¢ Transcatheter Ventricular Enhancement 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 the potential to improve blood flow throughout the body.
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.
Michelle McAdam, Chronic Communications, Inc.
[email protected], (310) 902-1274