Product information
Edwards Cardioband tricuspid valve reconstruction system
Valve Reconstruction
Restores valve to a more functional state - facilitating leaflet coaptation1
Annular Reduction
Enables annular reduction based on each patient’s anatomy
Real-time Adjustment
Allows real-time adjustment and confirmation of procedural results
- Nickenig, G. TRI-REPAIR: 30-Day Outcomes of Transcatheter TV Repair in Patients with Severe Secondary Tricuspid Regurgitation. Presented at TCT 2017.
Outcomes
Single arm, multicentre, prospective study to evaluate the performance and safety of the Cardioband tricuspid system for reconstruction of pathological tricuspid valves
Study Conclusions 1,2
Patients with functional tricuspid regurgitation have a large unmet need with limited treatment options
In early experience, the Cardioband tricuspid system provides
- Significant reduction in TR severity through annular reduction, sustained at 2 years
- Survival rate of 73% at 2 years
- Improvements in functional status, quality of life and exercise capacity through 2 years
- Nickenig G. et al. EuroIntervention 2021;16:e1264-e1271. DOI: 10.4244/EIJ-D-20- 01107
- Clinical trial available: https://clinicaltrials.gov/ct2/show/NCT02981953 (Accessed 12/02/2021)
73% Survival and 56% freedom from HF hospitalization at 2 years1,2
- Kaplan-Meier analysis time to first event ± SE. HF – Heart Failure
- Nickenig G. et al. Eurointervention 2021;16:e1264-61271. DOI: 10.4244/EIJ-D-20-01107
Sustained Annular Reduction and TR reduction at 2 years1 (Core lab2)
- Nickenig G. et al. Eurointervention 2020 Oct 13:EIJ-D-20-01107. doi: 10,4244/EIJ-D-20-01107
- Core Lab - Cardiovascular Research Foundation, New York, NY, USA;
- Mean, 95% confidence interval. Paired analysis; T-test for continuous variables and Wilcoxon signed-rank test for categorical variables
- baseline vs. discharge (n=22), baseline vs. one year (n=17) or baseline and two years (n=12).
- baseline vs. discharge (n=20), baseline vs. one year (n=15) or baseline and two years (n=10).
Sustained Functional Status Improvement at 2 Years1
- Nickenig G. et al. Eurointervention 2020 Oct 13:EIJ-D-20-01107. doi: 10,4244/EIJ-D-20-01107
- Wilcoxon Signed Rank Test, paired analysis comparing baseline vs. 30 days (n=28), baseline vs. 1 year (n=23) or baseline and 2 years (n=17).
- NYHA – New York Heart Association Functional Classification
Sustained Exercise Capacity and QoL Improvements at 2 Years1
- Nickenig G. et al. Eurointervention 2020 Oct 13:EIJ-D-20-01107. doi: 10,4244/EIJ-D-20-01107
- Paired T-test comparing baseline vs. 30 days (n=23), baseline vs. 1 year (n=19) or baseline and 2 years (n=12)
- Paired T-test comparing baseline vs. 30 days (n=20), baseline vs. 1 year (n=23) or baseline and 2 years (n=20). 6MWD – six-minute walk distance; KCCQ – Kansas City Cardiomyopathy Questionnaire; QoL – quality of life
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