REVA FANTOM II Performance and healing patterns by OCT Jo Simonsen, Emil Nielsen Holck, Didier Carrié, Nobert Frey, Matthias Lutz, Joachim Weber-Albers, Darius Dudek, Bernard Chevalier, Jouke Dijkstra, Jens Lassen, Jeffrey Anderson, Evald Høj Christiansen, Alexandre Abizaid, Niels Ramsing Holm On behalf of the FANTOM II investigators Niels Ramsing Holm Aarhus University Hospital, Denmark Exhibit 99.2
The FANTOM BRS Desaminotyrosine based polycarbonate backbone Strut thickness 125µm Sirolimus eluting for 3 months Full resorption within 3-4 years FANTOM II
FANTOM angiographic signature Radiopacity Covalently bound iodine in the polycarbonate backbone FANTOM II
FANTOM OCT signature Baseline 6 month FU FANTOM II 9 month FU
FANTOM BRS by 3D OCT FANTOM II 3D OCT by St Jude OPTIS
REVA FANTOM II – OCT analysis PCI Research Aarhus University Hospital, Skejby ● Denmark OCT billede af baseline og FU strut
Customized analysis QCU-CMS, Leiden University Medical Center, The Netherlands
REVA FANTOM II SKEJBY PCI Research Aarhus University Hospital, Skejby ● Denmark Strut thickness by micro-CT OCT analysis optimized and validated by micro-CT FANTOM II
REVA FANTOM II PCI Research Aarhus University Hospital, Skejby ● Denmark OCT analysis optimized and validated by micro-CT FANTOM II
REVA FANTOM II PCI Research Aarhus University Hospital, Skejby ● Denmark Baseline FU FANTOM II
FANTOM in bifurcations FANTOM II
Cohort A - Study Population N= 117 Patients 6 Month Follow-up Clinical & Imaging 6 Month Follow-up Clinical (n=108) Angiographic n=100 OCT n=73 Long Term Follow-up Clinical (annual through 5 years) Cohort B - Study Population N= 123 Patients 9 Month Follow-up Clinical & Imaging 6 Month Follow-up Clinical FU Long Term Follow-up Clinical (annual through 5 years) Angiographic ) N=105 OCT n=80 FANTOM II Study Population N= 240 Total Patients Enrolled FANTOM II
Mean stent area Baseline Follow-up Difference p-value Mean stent area (mm2) Cohort A 7.1 (1.5) 7.2 (1.4) 0.1 (-0.02;0.24) 0.12 Cohort B 7.4 (1.6) 7.3 (1.5) -0.1(-0.2;0.0) 0.16 Baseline FANTOM II Mean stent area, Cohort A Mean stent area, Cohort B 6m follow-up 9m follow-up Baseline Baseline
Minimal stent area Baseline Follow-up Difference p-value Minimal stent area (mm2) Cohort A 7.1 (1.5) 7.2 (1.4) 0.1 (-0.02;0.24) 0.12 Cohort B 6.1 (1.4) 6.0 (1.3) -0.1(-0.2;0.1) 0.43 FANTOM II 6m follow-up Baseline 9m follow-up Baseline Minimal stent area, Cohort B Minimal stent area, Cohort A
Mean lumen area Baseline Follow-up Difference p-value Mean lumen area (mm2) Cohort A 6.8 (1.7) 5.7 (1.4) -1.1 (-1.3;-0.9) <0.0001 Cohort B 7.1 (1.6) 5.6 (1.5) -1.6 (-1.7;-1.4) <0.0001 Baseline Baseline FANTOM II Mean luminal area, Cohort A Mean luminal area, Cohort B 9m follow-up 6m follow-up Baseline Baseline
Minimal lumen area Baseline Follow-up Difference p-value Minimal lumen area (mm2) Cohort A 6.8 (1.7) 5.7 (1.4) -1.1 (-1.3;-0.9) <0.0001 Cohort B 5.7 (1.4) 4.0 (1.4) -1.7(-1.9;-1.4) <0.0001 Baseline Baseline FANTOM II Minimal luminal area, Cohort A Minimal luminal area, Cohort B 6m follow-up 9m follow-up Baseline Baseline
Malapposition Baseline Follow-up Malapposition Cohort A 0.8% (0.0;3.5) 0.0% (0.0;0.0) Cohort B 1.6% (0.1;5.2) 0.0% (0.0;0.0) FANTOM II 6m follow-up Baseline 9m follow-up Baseline Cohort A Cohort B
Extra-stent lumen Baseline Follow-up Extra stent lumen area (mm2) Cohort A 0.05 (0.02;0.13) 0.00 (0.00;0.02) Extra stent lumen area (mm2) Cohort B 0.08 (0.03;0.18) 0.00 (0.00;0.02) FANTOM II
Neointimal area 6 months Cohort A 9 months Cohort B Mean neointimal area (mm2) 1.2 (1.0;1.4) 1.4 (1.2;1.7) Median (IQR) FANTOM II
Neointimal thickness 6 months Cohort A 9 months Cohort B Mean neointimal thickness (µm) 57 (40;77) 77 (57;105) Median (IQR) FANTOM II
Strut coverage 6 months Cohort A 9 Months Cohort B Covered struts 98.1% (95.9;99.4) 99.0% (98.3;100.0) Strut-level results FANTOM II Cohort A Cohort B
Conclusion OCT properties allows for in-procedure 3D evaluation Expected slight decrease in lumen area after 9 months No stent area reduction – no late recoil High completeness of strut coverage Limited neointimal growth Excellent resolution of acute extra-stent lumen and malapposition The Fantom BRS show promising healing patterns after 6 and 9 months
