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

  • 240 patients with clinical follow-up
  • 153 matched OCT image pairs
  • 28 centers
  • 8 countries

12-month Clinical Results presented at EuroPCR 2017

FANTOM II 24-month Results Presented EuroPCR 2018

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

Malapposition Resolved7

 Malapposition Baseline Follow up
Cohort A – 6 Month Follow up (n=73) 0.8% 0.0%
Cohort B – 9 Month Follow up (n=80) 1.6% 0%

Strut Coverage7

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 Global Clinical program

References:

  1. Abizaid, A. New 24-month data from the FANTOM II clinical trial. Presented EuroPCR 2018.
  2. 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.
  3. Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent: ABSORB III. Presented ACC 2017.
  4. 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.
  5. 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.
  6. Mauri L. 2-year clinical outcomes from the pivotal RESOLUTE US study. Presented ACC 2012.
  7. Holm, N. REVA Fantom II performance and healing patterns by OCT. REVA Symposium EuroPCR 2017.