Novel Stent Technologies: Update on Bioresorbable Stents Chuck Simonton, MD, FACC, FSCAI Chief Medical Officer Abbott Vascular Santa Clara, CA, USA CRT 2013

Chief Medical Officer Abbott Vascular, Santa Clara, CA Charles A. Simonton, MD Chief Medical Officer Abbott Vascular, Santa Clara, CA

Programs Update: Fully Bioresorbable Scaffolds Commercial authorization outside the United States* Abbott Vascular Companies with human experience Biotronik Reva Medical Elixir Medical Arterial Remodeling Technologies (ART) Kyoto Medical Planning (no recent activity in coronaries) Additional effort w/o human experience OrbusNeich Amaranth Medical Xenogenics/MultiCell (technology acquired from BTI) Biosensors No recent efforts Boston Scientific Cordis/J&J Medtronic *CAUTION: Investigational device limited by Federal (US) law to investigational use only.

Biotronik Serruys, P.W., PCR 2012

Reva Medical ReZolveTM Second generation device – ReZolveTM Scaffold design: Slotted/spiral design 7F guide catheter compatible (protective sheath) Strut thickness ~100; profile 1.83 mm 3.0 mm device can be expanded to 3.7 mm Treat vessels 2.9 to 3.4 mm Scaffold material: Tyrosine-based polycarbonate copolymer (Surmodics) Second generation device incorporates covalently bonded iodine to enhance radiopacity Drug: Sirolimus – 80 µg Thin coating -  5 µm, abluminal Kaluza, G. CRT 2011 Abizaid, A, TCT 2012

Reva RESTORE Clinical Strategy Costa, R., TCT 2012

Elixir DESolveTM Scaffold Design Scaffold Material Drug Markers at either end (see photo) 3.0, 3.25, and 3.5 mm diameters; 14 and 18 mm lengths 2.5 mm, 2.75 mm and 3.75 mm available later Strut thickness = 150 µm; profile 0.058” Scaffold is protected by peel-away sheath Scaffold Material PLLA-based Fully resorbed in 1-2 years Drug FIM device: Myolimus, licensed from Novartis (3 µg/mm) CE device: Novolimus (5 µg/mm); internally developed mTOR inhibitor Marker Beads Peel-Away Sheath Verheye, S. TCT 2012 Abizaid, A. CRT 2012 Verheye, S. TCT 2011 (live case)

Elixir DESolve FIM Trial Angiographic Results at 6 Months Verheye, S., PCR 2012

Arterial Remodeling Technologies (ART) Fajadet, J. TCT 2012

Arterial Remodeling Technologies (ART) Fajadet, J. TCT 2012

The Abbott Vascular Bioresorbable Vascular Scaffold: AbsorbTM 11

Total Absorb Pts Studied Comprehensive Clinical Trial Program Absorb™ 2011 2012 2013 2014 2015 2016 ABSORB Cohort A n = 30; FIM 5 Y ABSORB Cohort B n = 101; FIM 1 Y 2 Y 3 Y 4 Y 5 Y ABSORB Extend n = up to 1,000 Enrollment & Follow-Up 1 Y 2 Y 3 Y ABSORB II n = ~330 Enrollment & Follow-Up 1 Y 2 Y 3 Y ABSORB PHYSIOLOGY n = ~35 Enrollment & Follow-Up 1 Y 2 Y ABSORB FIRST* n = 10,000 Enrollment & Follow-Up 1 Y 2 Y ABSORB III n = ~1,502 Enrollment & Follow-Up 1 Y 2 Y 3 Y Please note patients studied are Absorb patients only. ABSORB Japan n = ~265 Enrollment & Follow-Up 1 Y 2 Y ABSORB China n = ~200 Enrollment & Follow-Up 2 Y 1 Y Total Absorb Pts Studied n=~599 n~965 n~5,709 n~13,463 n~13,463 n~13,463 >2,300 patients treated to date reflects clinical trial patients plus non-trial, real-world experience. Note: Sample sizes reflect ABSORB patients only. * n= 10,000 f/u at 6 months. 1.000 patients f/u at 1 -3 years, 1.000 patients at 2-4 years Smits, P. – ABSORB Cohort B1 – 3 year data, TCT 2012 Absorb Cohort B, Extend, II, Physiology, First, Japan and China are ongoing clinical trials outside the United States.

30 subjects (Non-randomized) 4 sites in Europe & New Zealand ABSORB Cohort A 30 subjects (Non-randomized) 4 sites in Europe & New Zealand Clinical Follow-Up (Months) 6 12 18 24 36 48 60 QCA, IVUS, OCT, IVUS VH MSCT Study Objective First In Man, Single Arm – safety/performance Endpoints Typical PCI clinical and imaging endpoints Treatment Single, de novo native coronary lesion in a vessel with a reference vessel diameter of 3.0 mm Device Sizes 3.0 x 12 mm scaffolds (3.0 x 18 mm scaffolds available after enrolment start and used in 2 pts) This is the trial design for ABSORB Cohort A. It included 30 patients. 6 sites participated in the trial, although only 4 sites actually enrolled patients. Most patients were treated with a 3.0 x 12 mm device. A 3.0 x 18 mm device became available toward the end of enrollment and consequently only 2 patients were treated with that size device. Ellis, S. - From ABSORB Cohort A to ABSORB III and IV Randomized Trials. April 2012.

ABSORB Cohort A Long-Term Data Out to 5 Years ABSORB Cohort A Clinical Results at Each Phase: Intent to Treat RESTORATION RESORPTION Hierarchical 6 Months 30 Patients 1 year 29 Patients** 2 Year 29 Patients** 5 Year 29 Patients** Ischemia Driven MACE*** 1 (3.3%)* 1 (3.4%)* Cardiac Death 0 (0.0%) MI Q-Wave MI Non Q-Wave MI Ischemia Driven TLR by PCI 0 (0.%) by CABG No scaffold thrombosis by ARC or Protocol * Same patient – this patient also underwent a TLR, not qualified as ID-TLR (DS = 42%) ** One patient withdrew consent and missed the 9, 12, 18 month and 2, 3, and 4 year visits; two patients died from a non-cardiac causes, one at 706 days and one at 888 days post procedure *** MACE – Composite endpoint comprised of cardiac death, myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR) by PCI or CABG Serruys, PW., TCT, 2011

ABSORB Cohort A – Intravascular Imaging at 5 years Scaffold Completely Resorbed and Vessel Healing Evident Late lumen gain and characteristic ‘final golden tube’ on OCT IVUS OCT ABSORB Cohort A MLA 6.35 mm2 6 month follow up In fact, 5-year follow up of Cohort A patients is showing that late lumen gains at 2 years are preserved at 5 years. And the characteristic appearance of a so-called golden tube on OCT is indicative of the beneficial remodeling that can take place after scaffold resorption. MLA 8.77 mm2 5 year follow up The ‘final golden tube’ R.J. van Geuns, PCR 2012. Images courtesy of Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands

ABSORB Cohort B 101 subjects (Non-randomized) 12 sites in Europe, Australia, New Zealand Group B1 (n = 45) Clinical Follow-Up (Months) 30 days 6 12 18 24 36 48 60 Group B2 (n = 56) QCA, IVUS, OCT, IVUS VH MSCT Study Objective First In Man, Single Arm – safety/performance Endpoints Typical PCI clinical and imaging endpoints Treatment Up to 2 de novo lesions in different epicardial vessels Reference vessel diameter of 3.0 mm, lesions ≤ 14 mm in length Device Sizes 3.0 x 18 mm devices Trial design for Cohort B. Enrolled 101 patients at 12 sites. Patients were divided into two groups: the first 45 patients come back for imaging follow-up at 6 and 24 months; the second group of 56 patients come back for imaging at 1 and 3 years. Smits, P. – ABSORB Cohort B1 – 3 year data, TCT 2012

ABSORB Cohort B Group 1&2 Clinical Results - Intent to treat 30 Days 30 Days 6 Months 6 Months 1 Year 1 Year 2 Years 2 Years Non - Hierarchical n = 101 n = 101 n = 101 n = 100* Cardiac Death % Cardiac Death % Myocardial Infarction % (n) Myocardial Infarction % (n) 2.0 (2) 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) Q Q - - wave MI wave MI Non Q Non Q - - wave MI wave MI 2.0 (2) 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) Ischemia driven TLR % (n) Ischemia driven TLR % (n) 2.0 (2) 2.0 (2) 4.0 (4) 4.0 (4) 6.0 (6) 6.0 (6) CABG CABG PCI PCI 2.0 (2) 2.0 (2) 4.0 (4) 4.0 (4) 6.0 (6) 6.0 (6) Hierarchical MACE % (n) Hierarchical MACE % (n) 2.0 (2) 2.0 (2) 5.0 (5) 5.0 (5) 6.9 (7) 6.9 (7) 9.0 (9) 9.0 (9) MACE: Cardiac death, MI, ischemia-driven TLR - TVF: Cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR No scaffold thrombosis by ARC or Protocol out to 2 – Year only 2 additional TLR events between 1 year and 2 year D. Dudek, ABSORB Cohort B Trial, Evaluation of the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold (Absorb BVS) in the Treatment of Patients with de novo Native Coronary Artery Lesions, 2-Year Clinical Results, ACC 2012 / *One patient missed the 2 year FUP

Insight on evolution of late luminal loss over times BVS 1.1 and Xience V (non-matched population) 6M BVS(Cohort B): 0.19±0.18 mm (N=42) 6M EES (SPIRIT I): 0.10±0.23 mm (N=22) mm

Insight on evolution of late luminal loss over times BVS 1.1 and Xience V (non-matched population) 6M BVS(Cohort B): 0.19±0.18 mm (N=42) 6M EES (SPIRIT I): 0.10±0.23 mm (N=22) mm

12 months Insight on evolution of late luminal loss over times BVS 1.1 and Xience V (non-matched population) 12 months 12M BVS (Cohort B): 0.27 ± 0.25 mm (N=56) 12M EES (SPIRIT I): 0.23 ± 0.29 mm (N=22) mm

24 months Insight on evolution of late luminal loss over times BVS 1.1 and Xience V (non-matched population) 24 months 24M BVS (Cohort B): 0.27 ± 0.20 mm (N=38) 24M EES (SPIRIT II): 0.33 ± 0.37mm (N=96) mm

Time After Index Procedure (days) Absorb™ BVS Low incidence of adverse events through 3 years KM estimate of MACE rate in patients treated with Absorb BVS (ABSORB Cohort B, n=101) ABSORB Cohort B1 – 3 year data Time After Index Procedure (days) 37 194 284 393 573 758 1123 Absorb™ BVS(B1+B2) At Risk 101 99 96 94 92 91 41 Smits P. – ABSORB Cohort B1 – 3 year data, TCT 2012

Absorb™ Vasomotor Function Testing 1 6 Months1 12 Months2 24 Months3 ABSORB Cohort B1 ABSORB Cohort B2 ABSORB Cohort A (n=15) (n=6) (n=19) (n=13) (n=9) (n=7) 0.5 Vasodilation  in Vessel Diameter (mm) (pre-drug infusion to post-drug infusion) Vasoconstriction -0.5 Acetylcholine Methergine -1 1. Adapted from Serruys, PW. ACC 2011 / 2. Adapted from Serruys, PW. ACC 2011 / 3. Adapted from Serruys, PW, et al. Lancet 2009; 373: 897-910.

Quantitative OCT Assessment of ABSORB BVS 1.1 Baseline Follow-up Strut area Strut Core area Strut Core area Capitals in title Lumen Area Scaffold Area Strut Core area Neointimal area =Scaffold area – Lumen area – Strut core area van Geuns, R. – ABSORB Cohort B1 – 2 Yr OCT data, AHA 2011

Minimal scaffold area, mm² Results of Quantitative OCT Serial Analysis OCT Post procedure (n=23) 6 month 24 month BL-2Y Mean scaffold area, mm2 7.47±1.18 7.70 ± 1.34 8.24 ± 1.83 Minimal scaffold area, mm² 6.22 ± 1.26 6.17 ± 1.46 6.36 ± 1.41 Mean Strut core area, mm2 0.21±0.03 0.20±0.05 0.15±0.02 Mean Neointimal area, mm2 1.43 ± 0.36 2.11 ± 0.41 Mean flow area, mm2 7.02 ± 1.24 6.07 ± 1.39 5.99 ± 1.61 Minimal flow area, mm2 5.68 ± 1.24 4.66 ± 1.42 4.22 ± 1.37 Area stenosis obstruction, % 19.36 ± 7.51 24.12 ± 10.45 29.70 ± 11.14 Uncovered struts, % 2.04 ± 2.68 1.03 ± 1.84 Incomplete strut apposition, mm2 0.25 ± 0.45 (n=11) 0.22 ± 0.17 (n=5) 1.97 (n=1) Scaffold enlargement !! < < < = = = = = > > > < > > > > > > > > < < < < non-significant change, < P < 0.05 Values are expressed as mean ± SD van Geuns, R. – ABSORB cohort B1 – 2 Yr OCT data, AHA 2011

Minimal scaffold area, mm² First signs of bioresorption Results of Quantitative OCT Serial Analysis OCT Post procedure (n=23) 6 month 24 month BL-2Y Mean scaffold area, mm2 7.47±1.18 7.70 ± 1.34 8.24 ± 1.83 Minimal scaffold area, mm² 6.22 ± 1.26 6.17 ± 1.46 6.36 ± 1.41 Mean Strut core area, mm2 0.21±0.03 0.20±0.05 0.15±0.02 Mean Neointimal area, mm2 1.43 ± 0.36 2.11 ± 0.41 Mean flow area, mm2 7.02 ± 1.24 6.07 ± 1.39 5.99 ± 1.61 Minimal flow area, mm2 5.68 ± 1.24 4.66 ± 1.42 4.22 ± 1.37 Area stenosis obstruction, % 19.36 ± 7.51 24.12 ± 10.45 29.70 ± 11.14 Uncovered struts, % 2.04 ± 2.68 1.03 ± 1.84 Incomplete strut apposition, mm2 0.25 ± 0.45 (n=11) 0.22 ± 0.17 (n=5) 1.97 (n=1) < < < = = = = > > First signs of bioresorption < > > > > > > > > < < < < non-significant change, < P < 0.05 van Geuns, R. – ABSORB Cohort B1 – 2 Yr OCT data, AHA 2011 Values are expressed as mean ± SD

Minimal scaffold area, mm² Well controlled inhibition of neointima Results of Quantitative OCT Serial Analysis OCT Post procedure (n=23) 6 month 24 month BL-2Y Mean scaffold area, mm2 7.47±1.18 7.70 ± 1.34 8.24 ± 1.83 Minimal scaffold area, mm² 6.22 ± 1.26 6.17 ± 1.46 6.36 ± 1.41 Mean Strut core area, mm2 0.21±0.03 0.20±0.05 0.15±0.02 Mean Neointimal area, mm2 1.43 ± 0.36 2.11 ± 0.41 Mean flow area, mm2 7.02 ± 1.24 6.07 ± 1.39 5.99 ± 1.61 Minimal flow area, mm2 5.68 ± 1.24 4.66 ± 1.42 4.22 ± 1.37 Area stenosis obstruction, % 19.36 ± 7.51 24.12 ± 10.45 29.70 ± 11.14 Uncovered struts, % 2.04 ± 2.68 1.03 ± 1.84 Incomplete strut apposition, mm2 0.25 ± 0.45 (n=11) 0.22 ± 0.17 (n=5) 1.97 (n=1) < < < = = = = = > > < Well controlled inhibition of neointima > > > > > > > > < < < < non-significant change, < P < 0.05 Values are expressed as mean ± SD van Geuns, R. – ABSORB cohort B1 – 2 Yr OCT data, AHA 2011

Minimal scaffold area, mm² Minimal reduction in functional lumen area Results of Quantitative OCT Serial Analysis OCT Post procedure (n=23) 6 month 24 month BL-2Y Mean scaffold area, mm2 7.47±1.18 7.70 ± 1.34 8.24 ± 1.83 Minimal scaffold area, mm² 6.22 ± 1.26 6.17 ± 1.46 6.36 ± 1.41 Mean Strut core area, mm2 0.21±0.03 0.20±0.05 0.15±0.02 Mean Neointimal area, mm2 1.43 ± 0.36 2.11 ± 0.41 Mean flow area, mm2 7.02 ± 1.24 6.07 ± 1.39 5.99 ± 1.61 Minimal flow area, mm2 5.68 ± 1.24 4.66 ± 1.42 4.22 ± 1.37 Area stenosis obstruction, % 19.36 ± 7.51 24.12 ± 10.45 29.70 ± 11.14 Uncovered struts, % 2.04 ± 2.68 1.03 ± 1.84 Incomplete strut apposition, mm2 0.25 ± 0.45 (n=11) 0.22 ± 0.17 (n=5) 1.97 (n=1) < < < = = = = = > > < > > > Minimal reduction in functional lumen area > > > < < < non-significant change, < P < 0.05 Values are expressed as mean ± SD van Geuns, R. – ABSORB cohort B1 – 2 Yr OCT data, AHA 2011

Minimal scaffold area, mm² Results of Quantitative OCT Serial Analysis OCT Post procedure (n=23) 6 month 24 month BL-2Y Mean scaffold area, mm2 7.47±1.18 7.70 ± 1.34 8.24 ± 1.83 Minimal scaffold area, mm² 6.22 ± 1.26 6.17 ± 1.46 6.36 ± 1.41 Mean Strut core area, mm2 0.21±0.03 0.20±0.05 0.15±0.02 Mean Neointimal area, mm2 1.43 ± 0.36 2.11 ± 0.41 Mean flow area, mm2 7.02 ± 1.24 6.07 ± 1.39 5.99 ± 1.61 Minimal flow area, mm2 5.68 ± 1.24 4.66 ± 1.42 4.22 ± 1.37 Area stenosis obstruction, % 19.36 ± 7.51 24.12 ± 10.45 29.70 ± 11.14 Uncovered struts, % 2.04 ± 2.68 1.03 ± 1.84 Incomplete strut apposition, mm2 0.25 ± 0.45 (n=11) 0.22 ± 0.17 (n=5) 1.97 (n=1) < < < < = = = = = = > > > < > > > > > > > > < < < Almost complete coverage of the struts with resolution of incomplete apposition < non-significant change, < P < 0.05 Values are expressed as mean ± SD van Geuns, R. – ABSORB cohort B1 – 2 Yr OCT data, AHA 2011

ABSORB EXTEND Non-Randomized, Single-Arm, Continued Access Trial ~1,000 subjects Up to 100 global sites (non-US) Clinical Follow-Up Clinical Follow-up (months) 6 12 18 24 36 MSCT follow up (n=100) OCT, IVUS follow up (n=50) Study Objective Continued Access trial. FPI: Jan 11, 2010 Endpoints Typical PCI clinical endpoints Treatment Up to 2 de novo lesions in different epicardial vessels Planned overlapping allowed in lesions >22 and ≤ 28 mm Device Sizes Scaffold diameters: 2.5, 3.0, 3.5 mm Scaffold lengths: 12*, 18, 28 mm Bartorelli, A, An Interim Report on the 12-Month Clinical Outcomes from the First 250 Patients Registered, and An Interim Report on the 6-Month Clinical Outcomes from the First 500 Patients Registered, TCT 2012 12 mm lengths in 3.0 and 2.5 mm diameters will be introduced into trial when available

Intent to Treat (ITT) Analysis – Interim Snapshot ABSORB EXTEND: One Year Outcomes in 250 Patients MACE at 12 Months Intent to Treat (ITT) Analysis – Interim Snapshot Bartorelli, A, An Interim Report on the 12-Month Clinical Outcomes from the First 250 Patients Registered, TCT 2012

Intent to Treat (ITT) Analysis – Interim Snapshot ABSORB EXTEND: One Year Outcomes in 250 Patients Ischemia-Driven TLR at 12 Months Intent to Treat (ITT) Analysis – Interim Snapshot Bartorelli, A, An Interim Report on the 12-Month Clinical Outcomes from the First 250 Patients Registered, TCT 2012

ABSORB Clinical Program: Summary Current clinical data for the Absorb™ BVS have shown: Safety and efficacy through 5 years (ABSORB Cohort A), through 2 years (ABSORB Cohort B), and through 1 year (EXTEND, interim 250 pts) No ST in ABSORB Cohort A1 and Cohort B3; low ST ABSORB EXTEND4 No new MACE from 6 months to 5 years (Cohort A) and between 1 and 3 years in ABSORB Cohort B Imaging data shows Possible restoration of vasomotor function by angio2 Late scaffold enlargement by OCT1 Resorption of Absorb™ has been shown on OCT, with the final golden tube at long-term follow-up* (5 Years, Cohort A) 1Serruys, PW., TCT 2011; 2 J. Ormiston, TCT 2011; 3 D. Dudek, ABSORB Cohort B Trial, Evaluation of the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold (Absorb BVS) in the Treatment of Patients with de novo Native Coronary Artery Lesions, 2-Year Clinical Results, ACC 2012 ; 4 Bartorelli, A, An Interim Report on the 12-Month Clinical Outcomes from the First 250 Patients Registered, and An Interim Report on the 6-Month Clinical Outcomes from the First 500 Patients Registered, TCT 2012 * Ongoing trial outside of the United States * Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands, ABSORB A 5 yr