Powerful Clinical Performance in International Patient Population
Demonstrated Safety & Efficacy
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 Maintained2
|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.
- Hermiller, J. Fantom: A Radio-Opaque “Stent-Like” BRS with Improved Expansion Characteristics. Presented TCT 2017. MACE = Cardiac Death + All MI + Clinically Driven TLR.; 24-month data is interim data set, n=125.
- Holm, N. REVA Fantom II performance and healing patterns by OCT. REVA Symposium EuroPCR 2017.