Powerful Clinical Performance in International Patient Population
Excellent Clinical Performance through 2 Years
FANTOM II primary endpoint was Major Adverse Cardiac Events (MACE) which includes non-target vessel MI. The 24-month MACE rate was 5.0%.
FANTOM II Data Set
Excellent Vessel Healing & Scaffold Coverage
In FANTOM II, REVA generated one of the largest OCT data sets for BRS. Results from the OCT study have demonstrated that the vessel lumen is maintained at 6 and 9 months follow up with minimal malapposition and excellent strut coverage. See our Education Center for OCT images from the study.
Vessel Patency Maintained7
|Mean Scaffold Area||Baseline||Follow up|
|Cohort A – 6 Month Follow up (n=73)||7.1mm2||7.2mm2|
|Cohort B – 9 Month Follow up (n=80)||7.4mm2||7.3mm2|
|Cohort A – 6 Month Follow up (n=73)||0.8%||0.0%|
|Cohort B – 9 Month Follow up (n=80)||1.6%||0%|
|Strut Coverage||Follow up|
|Cohort A – 6 Month Follow up (n=73)||98.1%|
|Cohort B – 9 Month Follow up (n=80)||99.0%|
FANTOM Global Clinical Program
REVA Medical is committed to advancing the field of BRS. The FANTOM Clinical Program is designed to evaluate performance in a variety of patient and lesion types.
FANTOM II 24-month Results, EuroPCR 2018.
FANTOM II 24-month OCT Analysis, EuroPCR 2018.
FANTOM II 12-month Results, EuroPCR 2017
FANTOM II 12-month OCT Analysis, EuroPCR 2017
FANTOM II Cohort A 6-mo Publication, JACC Cardiovascular Interventions 2017
Fantom Clinical Program, EuroPCR 2017
- Abizaid, A. New 24-month data from the FANTOM II clinical trial. Presented EuroPCR 2018.
- Chevalier B, et al. The 2-year Clinical Outcomes of the ABSORB II Trial: First Randomized Comparison between the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold and the XIENCE Everolimus Eluting Stent. TCT 2015.
- Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent: ABSORB III. Presented ACC 2017.
- Haude M, et al. Short and midterm safety, clinical performance and multimodality imaging results of the drug-eluting absorbable metal scaffold: Combined data of the BIOSOLVE-II and BIOSOLVE-III trials. EuroPCR 2017.
- Stone G, et al. Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents 2-Year Follow-Up From the SPIRIT IV Trial. JACC 2011;58(1):19-25.
- Mauri L. 2-year clinical outcomes from the pivotal RESOLUTE US study. Presented ACC 2012.
- Holm, N. REVA Fantom II performance and healing patterns by OCT. REVA Symposium EuroPCR 2017.