Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 1 Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI Richard J. Rapoza, PhD Divisional Vice President of R&D
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 2 MY CONFLICTS OF INTEREST ARE: Full time employee of Abbott Vascular
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 3 The Evolution of PCI Treatment Options BenefitsDetrimentsTLR PTCA 1970s Minimally invasive alternative to CABG Excellent long-term durability of results for patients who did well through ~6 months Acute/sub-acute closure High restenosis rates due to negative vessel remodeling 30 – 50% BMS 1980s Eliminated abrupt and sub-acute closure Reduced restenosis rates compared to PTCA Neointimal hyperplasia resulting in in-stent restenosis 15 – 30% DES 2000s Significantly reduced neointimal hyperplasia Reduced restenosis rates compared to BMS Late and very late stent thrombosis Dependence on long-term DAPT 5 – 10% Each of these new technologies addressed the shortcomings of the previous technology, but with their introduction arrived new, significant concerns
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 4 A New Therapy?: Vascular Restoration Therapy Medical Therapy PCI CABG PTCAStenting VRT Devices Used: BDC BMS DES BVS
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 5 Vascular Restoration Therapy (VRT) Restoration ResorptionRevascularization Restore vasomotor function Restore natural vessel structure Restore flow BMS & DES only accomplish this Only possible in the absence of a permanent implant Vessel is restored to a more natural state, capable of natural vascular function
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A Mos Support Mass Loss Tie chains Molecular Weight 1218 Polylactide Degradation vs Lumen Support Data on file at Abbott Vascular.
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 7 Model derived from Prabhu S and Hossainy S, J. Biomed. Mater. Res., Pt. A 2007; 80: 732. Tests were performed by and data are on file at Abbott Vascular. BVS Resorption in Healthy Porcine Model month 1 6 months 2 1 year 3 18 months 10X Magnification 4 2 years 5
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 8 Photos taken by and on file at Abbott Vascular. 2 years3 years 4 years Tests performed by and data on file at Abbott Vascular. 1.5 years % Mass Remaining Long Term Biological Response
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 9 ■ BVS Cohort A (n = 26) ■ BVS Cohort B1 (n = 42 ITT) ▲ EES (n = 22)* BMS (n = 27)* ABSORB Cohort B 6-Month QCA Cumulative Incidence Curve for Late Loss Adapted from Serruys, PW. PCR 2010 BMS LL = 0.85 ± 0.36 mm BVS Cohort A LL = 0.44 ± 0.35mm BVS Cohort B1 LL = 0.19 ± 0.18 mm EES LL = 0.10 ± 0.23 mm * SPIRIT-FIRST ABSORB is a trademark of the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 10 ABSORB Cohort A Clinical Results – Intent to treat Hierarchical 6 Months (n = 30) 12 Months (n = 29)* 24 Months (n = 29)* 36 Months (n = 29)* 48 Months (n = 29)* Ischemia Driven MACE 1 (3.3%)**1 (3.4%)** Cardiac Death0 (0.0%) MI1 (3.3%)**1 (3.4%)** Q-Wave MI 0 (0.0%) Non Q-Wave MI 1 (3.3%)**1 (3.4%)** Ischemia Driven TLR0 (0.0%) by PCI 0 (0.0%) by CABG 0 (0.0%) No new MACE between 6 and 48 months * One patient withdrew consent and missed the 9, 12, 18 month and 2, 3 and 4 year visits **This patient also underwent a TLR, not qualified as ID-TLR (DS = 42%) followed by post-procedural troponin qualified as NQMI and died from Hodgkin’s disease at 888 days post-procedure Serruys, PW., AHA No thrombosis up to 4 years (all patients off clopidogrel) ABSORB is a trademark of the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 11 ABSORB Cohort B Clinical Results - Intent to treat, Group 1 No thrombosis by ARC or Protocol Non-Hierarchical Cardiac Death (%) Myocardial Infarction n (%) Q-wave MI Non Q-wave MI Ischemia Driven TLR n (%) PCI CABG Hierarchical MACE n (%) Hierarchical TLF n (%) 30 Days 6 Months N = (2.2) (4.4) 1 (2.2) 2 (4.4) MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR 9 Months N = (2.2) (4.4) Serruys, PW., TCT 2010 Ormiston, J., TCT 2010 ABSORB is a trademark of the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 12 ABSORB Cohort B Clinical Results - Intent to treat, Group 1&2 No thrombosis by ARC or Protocol Non-Hierarchical Cardiac Death (%) Myocardial Infarction n (%) Q-wave MI Non Q-wave MI Ischemia Driven TLR n (%) PCI CABG Hierarchical MACE n (%) Hierarchical TLF n (%) 30 Days 6 Months N = (2.0) 3 (3.0) (2.0) 3 (3.0) 2 (2.0) (5.0) 2 (2.0) 5 (5.0) MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR Serruys, PW., AHA Months N = (3.0) 0 2 (2.0) 0 5 (5.0) ABSORB is a trademark of the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP Rev. A 13 Baseline6 mo follow up Baseline MLA: 7.39 mm 2 Follow up MLA: 8.18 mm 2 Coverage: 60 μm ABSORB Cohort B: OCT example ABSORB is a trademark of the Abbott Group of Companies Serruys, PW. PCR 2010 Serruys, PW. CCT 2010