1. One Year Results of the REMEDEE Registry Clinical Outcomes After Deployment of the Abluminal Sirolimus-Coated Bioengineered Stent (COMBO) in a Multicenter, Prospective Postmarket Registry Robbert J de Winter, MD PhD FESC On behalf of the REMEDEE Registry Investigators TCT 63: One Year Results REMEDEE Registry TCT 2015

2. Disclosure Statement of Financial Interest Robbert J de Winter Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit OrbusNeich; Astra Zeneca; Abbott; Stentys; Tryton; St Jude Medical OrbusNeich - Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial RelationshipCompany

3. COMBO stent design  Stainless Steel 100 µm  Abluminal biodegradable polymer matrix  Sirolimus elution  EPC capturing technology for accelerated endothelial coverage One Year Results REMEDEE Registry TCT 2015

4. Abluminal Sirolimus Drug Delivery from a completely biodegradable polymer matrix Granada J et al., Circ Cardiovasc Intervent. 2010; 3:257-266 In vivo elution profile of COMBO and Cypher (% of total drug eluted over time) Polymer matrix resorption within 90 days

5. Luminal Endothelial Progenitor Cell (EPC) Capture G70-0157 Rev 02 One Year Results REMEDEE Registry TCT 2015

6. Combo Dual Therapy Stent Clinical Trial Program N= 183 Completed Clinical FU Ongoing Prospective, Multicenter Randomized Study REMEDEE N= 61 2-5, 9, 24 Months Completed Single Center Study with Longitudinal OCT Assessment of COMBO’s Healing Profile EGO COMBO REMEDEE OCT Prospective, Multicenter, Randomized Study N= 60 30d, 6, 12 Months Completed In Preparation N= 2500 Prospective, Multicenter, Worldwide All-comers Post-market Registry Enrolling MASCOT N= 1000 Prospective, Multicenter, All-comers Post-market Registry Enrolment Completed REMEDEE Registry Enrolling N= 1500 Prospective, Multicenter, Randomized Study with Reduced DAPT in ACS Patients REDUCECOSTA N= 900 Prospective, Multicenter, Randomized Study with short Dual Therapy in Patients on Oral Anti- Coagulants Enrolment commencing Q2 2015 N= 436 Prospective, Multicenter, Randomized Study for China Approval COMBO China Enrolment Commenced Feb 8, 2014 N= 572 Prospective, Multicenter, Randomized Study for Japan and U.S. Approval HARMONEE Japan & US

7. REMEDEE Registry Primary objective: To evaluate the immediate and long term safety and performance of the abluminal sirolimus coated bio-engineered stent (COMBO) in routine clinical practice Primary endpoint: Target Lesion Failure  Cardiac Death  Non-Fatal Target Vessel MI  Target Lesion Revascularization One Year Results REMEDEE Registry TCT 2015

8. All-comers Registry Patients are only excluded from registration if ANY of the following conditions apply: High probability of non-adherence to the follow-up requirements; Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned; A life expectancy of <1 year; Explicit refusal of participation in the registry. One Year Results REMEDEE Registry TCT 2015

9. Participating sites Amsterdam, The Netherlands Academic Medical Centre Prof. Dr. de Winter Blaricum, The Netherlands Ter Gooi Ziekenhuizen Dr. Arkenbout Breda, The Netherlands Amphia ziekenhuis Dr. den Heijer Craigavon, UK Craigavon Cardiac Centre Dr. Menown Zwolle, The Netherlands Isala Klinieken Dr. van ‘t Hof Luxembourg Centre Hospitalier de Luxembourg Dr. Muller Nijmegen, The Netherlands Radboud University Nijmegen Prof. Dr. Suryapranata Riga, Latvia Stradina University Hospital Prof. Dr. Erglis Vigo, Spain Meixoeiro Hospital Dr. Iniguez One Year Results REMEDEE Registry TCT 2015

10. All-comers flash type registry March 14 th 2014 June 3 rd 2013 One Year Results REMEDEE Registry TCT 2015

11. Registration per hospital One Year Results REMEDEE Registry TCT 2015

12. True all-comers registry Min Max Age 34-94years Length 143-200cm Number of risk factors 0/8-8/8 Systolic blood pressure 55-226mmHg Lesion length 2-117mm Number of stents 0-4 One Year Results REMEDEE Registry TCT 2015

13. Patient Characteristics n=1000 Age, years65±11 Sex, male73.9% Risk FactorsMedical History Diabetes18.4%Congestive heart failure (EF<30%)3.2% No medication/unknown9.7%Chronic renal failure6.1% Oral medication55.7%Peripheral vascular disease7% Insulin 34.6%Previous stroke6% Hypertension58%Prior myocardial infarction25.3% Hypercholesterolemia56.2%Unknown27.3% Family history of CAD45.5%In current PCI area24.9% Smoker52.3%In other than PCI area47.8% Previous28.2%Prior PCI30.1% Current24.1%Prior CABG6.8% One Year Results REMEDEE Registry TCT 2015

14. Indication for PCI Urgent30.4% STEMI 58.7% NST-ACS 27.4% Unstable angina 13.9% Elective69.6% Stabilized STEMI 3.0% Stabilized NST-ACS 15.4% Stabilized unstable angina 9.6% Stable angina and/or documented ischemia 43.6% Angiographic driven 23.2% Other 5.2% One Year Results REMEDEE Registry TCT 2015

15. Medication at Discharge Antiplatelet therapy Aspirin 90.9% Clopidogrel 55.8% Prasugrel 2.5% Ticagrelor 25.5% Other cardiac medication ACE inhibitor 41.9% Beta blocker 73.1% Calcium channel blocker 21.7% Coumarin 3.5% Diuretics 20.7% Long acting nitrate 27.1% LMWH 14.7% Statin 79.5% One Year Results REMEDEE Registry TCT 2015

16. Lesion Characteristics Multivessel disease (>1 vessel, >70%)21.1% Treated lesions (n=1511) Left main1.3% LAD50.6% LCx20.2% RCA26.1% Bypass graft1.8% Number of vessels treated One vessel PCI89.5% Multivessel PCI10.5% AHA/ACC lesion type A16.4% B124.9% B237.5% C21.1% TIMI flow pre-procedure 014.5% 1 4.5% 2 9.8% 371.3% One Year Results REMEDEE Registry TCT 2015 50% }

17. Length17.7±10.3mm Reference vessel diameter3.2±0.5mm Percentage diameter stenosis*88.4±31.2% * By visual estimate Thrombus present 15.2% Indication for treatment Native coronary artery 95.4% Venous bypass graft 1.5% Bypass graft 0.1% In-stent restenosis 1.8% In-stent thrombosis 0.1% Other 1.0% One Year Results REMEDEE Registry TCT 2015 Lesion Characteristics

18. Pre-dilatation 69.9% Number of stents per lesion 1.1±0.37 1 stent per lesion 89.8% >1 stent per lesion 10.2% Stent length19.3±6.4 Stent length ≤ 15mm 38.7% Stent length > 15mm 61.3% Stent Diameter3.2±0.4 Stent diameter ≤ 3.0mm 59.4% Stent diameter > 3.0mm 40.5% Stent max pressure (atm)13.6±3.8 Thrombus aspiration10.8% Thrombus aspiration in STEMI83.3% Device success*98.7% Procedural success†97.7% One Year Results REMEDEE Registry TCT 2015 Procedural Characteristics

19. Primary Endpoint N(%) Primary endpoint: TLF575.7 One Year Results REMEDEE Registry TCT 2015

20. Primary Endpoint N(%) Primary endpoint: TLF575.7 Cardiac death171.7 Target vessel MI70.7 TLR434.4 One Year Results REMEDEE Registry TCT 2015

21. Primary Endpoint N(%) Primary endpoint: TLF575.7 Cardiac death171.7 Target vessel MI70.7 TLR434.4 TVR484.9 Definite ST50.5 Probable ST10.1 One Year Results REMEDEE Registry TCT 2015

22. Primary endpoint: Target Lesion Failure One Year Results REMEDEE Registry TCT 2015 5.7%

23. Secundary endpoints One Year Results REMEDEE Registry TCT 2015 0.7% 4.4% 4.8% 1.7% Cardiac Death MI TVR TLR

24. Comparing REMEDEE Registry with other recent all-comers DES Trials REMEDEE Registry TWENTEDUTCH PEERSLEADERS COMBO Resolute ZES Xience V EES Resolute ZES Promus EES Biomatrix BES Cypher SES N1000697694906905857850 TLF 5.77.96.86.05.0 6.57.4 TVF6.28.28.16.05.0 10.612.0 TV-MI0.74.6 2.01.05.8*4.6* Cardiac death1.74.94.84.02.02.12.7 Clinically indicated TVR 4.93.32.73.0 5.87.1 Definite ST 0.50.60.00.31.02.0 Probable ST (1Y)0.10.81.20.2 0.80.2 One Year Results REMEDEE Registry TCT 2015

25. Patient Characteristics Stent Thrombosis Patient Baseline presentation Treated Lesion Days post COMBO stent placement Thrombosis type Repeat revascularization 40-year male STEMIRCA distal<1Definite balloon angioplasty 83-year female STEMILAD proximal<1Definiteballoon angioplasty 52-year male STEMILAD proximal<1Definiteballoon angioplasty 77-year male Stable anginaLAD mid<1Definitestent placement 69-year male Stabilized NST-ACS LAD mid9Definitestent placement 41-year male STEMILAD proximal8Probable*n/a* One Year Results REMEDEE Registry TCT 2015

26. Stent thrombosis One Year Results REMEDEE Registry TCT 2015 Definite and probable ST 0.6%

27. Strengths & Limitations REMEDEE Registry is a true all-comers study  Few exclusion criteria  Fast enrollment  Balanced contribution of participating centers All events adjudicated by independent clinical events committee The REMEDEE Registry will collect FU untill 5Y REMEDEE Registry is a registry One Year Results REMEDEE Registry TCT 2015

28. Conclusions REMEDEE Registry is a 1000 patient, true all-comers study Excellent procedural success with COMBO Primary endpoint (TLF) @ 1Y was 5.7% This compares well with results from recent other all-comer trials Definite / probable ST was low and no ST occurred after 9 days post procedure The ongoing COMBO clinical program will provide more data regarding safety and efficacy in different patient populations One Year Results REMEDEE Registry TCT 2015

29. Study Team Investigators: R.J. de Winter E.K. Arkenbout P. den Heijer I. Menown P. Muller H. Suryapranata A. Erglis A. Iniguez A. van ‘t Hof Research Fellows: D.N. Kalkman P. Woudstra H. Lu M. Beijk Study Nurses: M.I. Klees N. Van Daalen Y. Kwan Chan A.Vinken One Year Results REMEDEE Registry TCT 2015 Senior Statistician : J.G.P. Tijssen CEC: B. Rensing F. Eeftink Trial Management: G. Peeters

30. Thank You One Year Results REMEDEE Registry TCT 2015