REVA Medical — Technical Presentation (May 2018)
24 slides from REVA Medical's technical presentation, May 23, 2018
Slide 1: REVA FANTOM II Performance and healing patterns by OCT: Two-year serial follow-up
REVA FANTOM II Performance and healing patterns by OCT Two-year serial follow-up Emil Nielsen Holck, Jo Simonsen, Didier Carrié, Nobert Frey, Matthias Lutz, Joachim Weber-Albers, Darius Dudek, Bernard Chevalier, Jouke Dijkstra, Jens Lassen, Jeffrey Anderson, Joest daemen, Evald Høj Christiansen, Ale
Slide 2: The FANTOM BRS
The FANTOM BRS Desaminotyrosine based polycarbonate backbone Strut thickness 125µm Sirolimus eluting for 3 months Full resorption within 3-4 years FANTOM II
Slide 3: FANTOM angiographic signature
FANTOM angiographic signature Radiopacity Covalently bound iodine in the polycarbonate backbone FANTOM II
Slide 4: FANTOM BRS by 3D OCT
FANTOM BRS by 3D OCT FANTOM II 3D OCT by St Jude OPTIS
Slide 5: FANTOM OCT signature
FANTOM OCT signature Baseline 6 month FU FANTOM II 24 month FU
Slide 6: REVA FANTOM II – OCT analysis
REVA FANTOM II – OCT analysis PCI Research Aarhus University Hospital, Skejby ● Denmark OCT billede af baseline og FU strut
Slide 7: Customized analysis
Customized analysis Lumen Abluminal stent Luminal stent Stent strut QCU-CMS, Leiden University Medical Center, The Netherlands
Slide 8: Strut thickness by micro-CT
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
Slide 9: OCT analysis optimized and validated by micro-CT
REVA FANTOM II PCI Research Aarhus University Hospital, Skejby ● Denmark OCT analysis optimized and validated by micro-CT FANTOM II
Slide 10: Baseline and follow-up FANTOM
REVA FANTOM II PCI Research Aarhus University Hospital, Skejby ● Denmark Baseline FU FANTOM II
Slide 11: Micro-CT FANTOM in bifurcations
Micro-CT FANTOM in bifurcations FANTOM II
Slide 12: Patient flow chart
FANTOMII Patient flow chart FANTOM II Study Population N= 240 Total Patients Enrolled — | Cohort B study Population Cohort A- Study Population 6 Month Follow-up ‘9 Month Follow-up Gil & imaging rol peace, | aregonie mreoenone | | ot mia or | Ls 6 Month Follow-up ‘9 Month Follow-up inl (108) lal 24 M
Slide 13: FANTOM II Analysis flow chart
FANTOM II Analysis flow chart TLR
Slide 14: Mean scaffold area
Mean scaffold area FANTOM II 7.32±1.14 mm2 7.43±1.19 mm2 7.45±1.28 mm2
Slide 15: Minimal scaffold area
Minimal scaffold area FANTOM II 6.14±1.09 mm2 6.25±1.16 mm2 5.99±1.17 mm2
Slide 16: Mean lumen area
Mean lumen area FANTOM II 7.09±1.38 mm2 6.01±1.32 mm2 5.87±0.19 mm2
Slide 17: Minimal lumen area
Minimal lumen area FANTOM II 5.58±1.09 mm2 4.65±1.10 mm2 4.10±1.21 mm2
Slide 18: Malapposition
Malapposition FANTOM II 0.6% [0.0;4.6] 0.0% [0.0;0.0] 0.0% [0.0;0.0] p=0.67 p<0.001
Slide 19: Extra-stent lumen
Extra-stent lumen 24 months follow-up cohort baseline 6 months 24 months Extra stent lumen area (mm2) 0.04[0.03;0.19] 0.01[0.00;0.03] 0.00[0.00;0.01] FANTOM II p<0.001 p=0.05
Slide 20: Extra-stent lumen
Extra-stent lumen FANTOM II No evaginations or late scaffold detachment after 24 months Example in permanent DES. Radu et al. EHJ 2017
Slide 21: Neointimal area
Neointimal area 24 months follow-up cohort 6 months 24 months p-value Mean neointimal area (mm2) 1.20±0.31 1.52±0.37 <0.001 FANTOM II Blue area: Neointimal area
Slide 22: Neointimal thickness
Neointimal thickness 24 month follow-up cohort 6 months 24 months p-value Mean neointimal thickness (µm) 51[36;67] 79[53;110] 0.01 Median (IQR) FANTOM II
Slide 23: Strut coverage
Strut coverage Strut-level results in 24m follow-up cohort FANTOM II 98.6% [96.5;99.7] 100% [100;100]
Slide 24: Conclusion
Conclusion Complete strut coverage Slight decrease in lumen area due to limited additional neointimal growth – mainly in cases with small acute MLA No stent area reduction – no late recoil Excellent resolution of acute malapposition and still no acquired malapposition and no evaginations detected af