1. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 TAXUS II International Study Comparative 6 month clinical QCA & IVUS results TAXUS NIRx stent system Slow and Moderate release Paclitaxel formulation Dr Adrian Banning John Radcliffe Hospital, Oxford On behalf of the TAXUS II Investigators

2. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Paclitaxel (1  g/mm 2 total loaded) Potent microtubular inhibitor Multifunctional Slow (SR) and Moderate (MR) release formulations Translute TM polymer regulates controlled biphasic release & allows variable elution profile (cf Cypher) NIRx TM Conformer Stent System Pre-mounted 15mm Conformer stent with 20mm balloon Advance Delivery System Diameters 3.0 & 3.5 mm Paclitaxel (1  g/mm 2 total loaded) Potent microtubular inhibitor Multifunctional Slow (SR) and Moderate (MR) release formulations Translute TM polymer regulates controlled biphasic release & allows variable elution profile (cf Cypher) NIRx TM Conformer Stent System Pre-mounted 15mm Conformer stent with 20mm balloon Advance Delivery System Diameters 3.0 & 3.5 mm TAXUS NIRx TM

3. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Objective TAXUS II Evaluate safety and performance of the two consecutive cohorts for the treatment of de novo coronary lesions: Cohort I: Comparing TAXUS slow release randomised 1:1 against bare stent control Cohort II: Comparing TAXUS moderate release randomised 1:1 against bare stent control TAXUS II Evaluate safety and performance of the two consecutive cohorts for the treatment of de novo coronary lesions: Cohort I: Comparing TAXUS slow release randomised 1:1 against bare stent control Cohort II: Comparing TAXUS moderate release randomised 1:1 against bare stent control

4. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Study Overview Randomised (1:1) Triple-blind International, multi-centre 536 patients –TAXUS NIRx SR - 267 –TAXUS NIRx MR - 269 30d, 6 mo, 1- 5 year FU Endpoints: –Clinical –QCA –IVUS Randomised (1:1) Triple-blind International, multi-centre 536 patients –TAXUS NIRx SR - 267 –TAXUS NIRx MR - 269 30d, 6 mo, 1- 5 year FU Endpoints: –Clinical –QCA –IVUS Inclusion Criteria Standard risk de novo lesions Length < 12 mm RVD > 3.0 & < 3.5mm Anti-platelet regimen –ASA > 75mg Maintained indefinitely –Clopidogrel Loading dose 300 mg 75 mg q.d. for 6 months Inclusion Criteria Standard risk de novo lesions Length < 12 mm RVD > 3.0 & < 3.5mm Anti-platelet regimen –ASA > 75mg Maintained indefinitely –Clopidogrel Loading dose 300 mg 75 mg q.d. for 6 months

5. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 In vitro Release Kinetics Biphasic: 48h burst then slower 10 day low level phase Same total loaded dose - different release rates Biphasic release - early burst and sustained release phases 8 fold difference in release rate between SR and MR Same total loaded dose - different release rates Biphasic release - early burst and sustained release phases 8 fold difference in release rate between SR and MR 0% 5% 10% 15% 024681012 Time (days) % PTx released N = 3 N = 9 Early Burst Phase Sustained Low Level Release Phase 8-10 fold difference % Paclitaxel Released 024681012 Days % Paclitaxel released 0% 5% 10 15 Slow Release 1  g/mm 2 Moderate Release 1  g/mm 2

6. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 TAXUS II Global Investigators Banning, Adrian Belardi, Jorge Benit, Edouard Bilodeau, Luc Bonnier, Edouard Camenzind, Edoardo Chan, Charles Colombo, Antonio Dawkins, Keith Drzewiecki, Janusz Dudek, Dariusz Figulla, Hans Fort, Stephen Grube, Eberhard Guagliumi, Giulio Hamburger, Jaap Hauptmann, Karl Kelbaek, Henning LeBlanche, Jean-Michel Banning, Adrian Belardi, Jorge Benit, Edouard Bilodeau, Luc Bonnier, Edouard Camenzind, Edoardo Chan, Charles Colombo, Antonio Dawkins, Keith Drzewiecki, Janusz Dudek, Dariusz Figulla, Hans Fort, Stephen Grube, Eberhard Guagliumi, Giulio Hamburger, Jaap Hauptmann, Karl Kelbaek, Henning LeBlanche, Jean-Michel Meredith, Ian Muenzel, Thomas Neinaber, Christoph Nordrehaug, Jan Pfisterer, Matthias Ormiston, John Reeves, Francois Roy, Louis Rutsch, Wolfgang Ruzyllo, Witold Schiele, Francois Silber, Sigmund Siminiak, Tomasz Strauss, Bradley Urbaszek, Wilhelm Webb, John Whitbourn, Robert Zmudka, Krzysztof Meredith, Ian Muenzel, Thomas Neinaber, Christoph Nordrehaug, Jan Pfisterer, Matthias Ormiston, John Reeves, Francois Roy, Louis Rutsch, Wolfgang Ruzyllo, Witold Schiele, Francois Silber, Sigmund Siminiak, Tomasz Strauss, Bradley Urbaszek, Wilhelm Webb, John Whitbourn, Robert Zmudka, Krzysztof Real world experience (15 countries, 38 sites) Randomized, triple blinded study with 536 pts >95% Angiographic and >87% IVUS FU Real world experience (15 countries, 38 sites) Randomized, triple blinded study with 536 pts >95% Angiographic and >87% IVUS FU

7. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Study Management Angiographic & IVUS: Cardialysis Core Analysis: Rotterdam, The Netherlands CEC: 7 independent members DMC: 4 independent members Study Coordination: PPD Development Paris, France Central Lab: COVANCE Bioanalytical Services Indianapolis, Indiana Industry Sponsor: Boston Scientific Corporation Angiographic & IVUS: Cardialysis Core Analysis: Rotterdam, The Netherlands CEC: 7 independent members DMC: 4 independent members Study Coordination: PPD Development Paris, France Central Lab: COVANCE Bioanalytical Services Indianapolis, Indiana Industry Sponsor: Boston Scientific Corporation

8. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Demographics No Significant Differences Between Groups 61.0 15.0 27.0 36.0 42.0 15.0 59.8 + 9.7 78.0 Combined Control (%) (n=270) 63.0 11.0 21.0 35.0 11.0 61.5 + 10.5 70.0 TAXUS NIRx SR (%) (n=131) 60.0 Hypertension 17.0 Diabetes 24.0 Smoker 30.0 Unstable Angina 39.0 Prior MI 17.0 Prior Intervention 59.3 + 10.1 Age 76.0 Male TAXUS NIRx MR (%) (n=135)

9. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 TAXUS II Baseline Lesion Characteristics Combined Control (n=270) TAXUS NIRx SR (n=131) TAXUS NIRx MR (n=135 ) P-value SR vs. Combined Control P-value MR vs. Combined Control P-value SR vs. MR RVD (mm) 2.75 + 0.5 2.78 + 0.4 2.72 + 0.5 0.59960.44420.2656 MLD (mm) 1.0 + 0.4 1.0 + 0.3 0.9 + 0.3 0.23850.48950.1063 Diameter Stenosis (%) 64.7 + 11.1 63.3 + 9.6 64.9 + 10.3 0.21080.84340.2088 Lesion Length mm) 10.6 + 4.1 10.5 + 3.9 10.2 + 4.8 0.89680.31250.4498 Well matched RVD at 2.75mm and Lesion Length at 10.5mm

10. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Stent Distribution Predominantly Single Stents Implanted 0.5298 0.6480 P-value SR vs. Control 4 (6) 94 (127) 1 (2) 15.7 +3.1 50% (70) 50% (69) 96% TAXUS NIRx MR (n=135) 1.0000 0.3557 P-value MR vs. Control 0.628454% (72) 50% (140) 3.5 0.628446% (62) 50% (138) 3.0 Study Stent Distribution 0.766795% 94% Clinical Procedural Success 5 (6) 4% (12) 2 93 (122) 94% (254) 1 2 (3) 1% (4) None Study Stents (per pt) 15.7 +3.2 Study Stent Length, mm (per pt) TAXUS NIR SR (n=131) P-value SR vs. MR Combined Control (n=270)

11. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Early Clinical Events No differences in SR, MR or Controls One peri-procedural stent thrombosis of 266 TAXUS stents placed 0.0%0.8%0.0% < 1 day 0.0% 30 days - 180 days 2.0 % (3) 4.0% (12) 30-day MACE 2.0% (3) Periprocedural MACE Stent Thrombosis TAXUS NIRx SR (n=131) Combined Control (n=270) TAXUS NIRx MR (n=135) 4.0% 2.0% (3) 1 day - 30 days 0.0% MI (n) Death (n) (1) (11) (2) (3) (0) 0.0%

12. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 1.0000 0.7572 0.0080 0.0262 0.1567 1.0000 0.0035 P-value SR vs. Combined Control 1.0 (1) 2.3 (3) 3.1 (4) 6.2 (8) 2.3 (3) 0.0 7.8 (10) TAXUS NIRx MR (n=135) Rate %/ (n) 1.0000 0.0010 0.0059 0.4029 1.0000 0.0019 P-value MR vs. Combined Control 1.0000 3.1 (4) 2.7 (7) TVR Remote 1.0000 0.8 (1) 0.8 (2) CABG 0.7490 4.6 (6) 13.3 (35) TLR 1.0000 8.5 (11) 19.8 (52) 6-Month MACE 0.8078 0.6838 P- value SR vs. MR 7.7 (10) 1.5 (2) 0.0 TAXUS NIRx SR (n=131) Rate % / (n) 16.0 (42) TVR - Overall 4.6 (12) Non Q-Wave MI 0.8 (2) Q-Wave MI 0.4 (1) Death Combined Control (n=270) Rate % / (n) TAXUS II 6 mo. Major Adverse Cardiac Events N/A Improvements in SR and MR

13. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Six month Binary Restenosis Decreased in stented segment not in edges Stented Segment Proximal EdgeDistal Edge 5mm P<0.0001 n=128n=263n=128n=127n=261n=128n=127n=262n=128 P<0.0001 P=0.500 P=1.000 P=0.509 P =0.515 P=0.758 P=1.000

14. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 2.3% (3/128) 1.6% (2/127) 3.1% (8/262) Distal Edge 2.3% (3/128) 1.6% (2/127) 3.4 % (9/261) Proximal Edge 22.0% (58/264) 18.6% (49/263) 19.0% (50/263) Combined Control (n=270) 8.6% (11/128 ) 0.8% ( 1/128) 4.7% (6/128) TAXUS NIRx MR (n=135 ) 5.5% (7/128) Total Analysis Segment 1.5% (2/128) If confounders excluded 2.3% ( 3/128) Stented Segment TAXUS NIRx SR (n=131) 6 mo. Restenosis Rates Improvements for TAXUS SR and MR Stented Segment: All stents (study and non-study) used to treat target lesion Total Analysis Segment: Stented segment + 5 mm proximal and distal edge Stented Segment: All stents (study and non-study) used to treat target lesion Total Analysis Segment: Stented segment + 5 mm proximal and distal edge

15. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 QCA Analysis of Stented Segment 0.80 + 0.55 0.51 + 0.32 0.78 + 0.47 1.57 + 0.37 Combined Control (n=270) 1.29 + 0.53 0.21 + 0.41 0.30 + 0.39 1.58 + 0.41 TAXUS NIRx MR (n=135 ) 1.21 + 0.53 Net Gain (mm) 0.22 + 0.30 Loss Index 0.31 + 0.38 Late Loss (mm) 1.52 + 0.37 Acute Gain (mm) TAXUS NIRx SR (n=131) Improved Acute Gain and Late Loss lead to significant improvements in Net Gain

16. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Comparative TAXUS II Clinical Summary Matched demographics in combined control, SR & MR Excellent control outcomes At 6 mo, SR & MR superior compared with combined control –MACE reduced by >60% –TVR reduced by >60% due to TLR being reduced by >60% –Beneficial edge effects on 6 mo. MLD and late loss Only 1/266 late TLR in regions treated by TAXUS NIRx SR and MR excellent with comparable late MACE rates Matched demographics in combined control, SR & MR Excellent control outcomes At 6 mo, SR & MR superior compared with combined control –MACE reduced by >60% –TVR reduced by >60% due to TLR being reduced by >60% –Beneficial edge effects on 6 mo. MLD and late loss Only 1/266 late TLR in regions treated by TAXUS NIRx SR and MR excellent with comparable late MACE rates

17. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 n=270n=131 n=135 + 17.5 +9.9+ 9.7 IVUS Primary Endpoint Met Reduced 6 mo. % In-Stent Net Volume Obstruction P=0.997 P<0.0001 No difference in SR vs. MR Superior SR & MR vs. Control P<0.0001

18. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Stent Volume (mm 3 ) +41.17 Stent Volume (mm 3 ) at 6 mo. FU No change in Stent Volume for all groups +42.44+48.81 n=244n=118 P=0.670 P=0.718 P=0.520

19. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Vessel Volume (mm 3 ) +76.48 Vessel Volume (mm 3 ) at 6 mo. FU No change in Vessel Volume for all groups +89.66+97.55 n=214n=110n=104 P=0.414 P=0.142 P=0.558

20. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 +28.23 +13.26 Neointimal Hyperplasia (mm 3 ) at 6 months Reduced for TAXUS SR & MR vs control +17.29 n=244n=118 P<0.0001 P=0.742 P<0.0001

21. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Summary of key IVUS findings Blinded, randomized study of 536 patients provides largest IVUS data set in DES field with paired FU Comprehensive IVUS (pre, post & 6 mo. FU) data set for TAXUS & large control group shows: 1) Stent volumes stable for TAXUS (SR & MR) & Controls 2) Vessel volumes stable for TAXUS (SR & MR) & Controls 3) Improved TAXUS SR & MR volumetric indices  neointimal hyperplasia reduced  % net volume obstruction reduced  No differences between SR & MR 4) IVUS improvements concordant with QCA gains Blinded, randomized study of 536 patients provides largest IVUS data set in DES field with paired FU Comprehensive IVUS (pre, post & 6 mo. FU) data set for TAXUS & large control group shows: 1) Stent volumes stable for TAXUS (SR & MR) & Controls 2) Vessel volumes stable for TAXUS (SR & MR) & Controls 3) Improved TAXUS SR & MR volumetric indices  neointimal hyperplasia reduced  % net volume obstruction reduced  No differences between SR & MR 4) IVUS improvements concordant with QCA gains

22. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Cumulative Frequency Distribution of Percent Diameter Stenosis by QCA Percentile 0 20 40 60 80 100 Pre procedure No differences Post procedure No differences Control Improved % DS SR & MR at 6-mo SR MR TAXUS SR TAXUS MR Control TAXUS SR TAXUS MR Control

23. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 6 mo. Late Loss within Stented Segment Improved in TAXUS SR and MR vs. Combined Control TAXUS SR & MR –Left shift towards reduced late loss for TAXUS SR & MR –Tighter frequency distribution for TAXUS vs. Control TAXUS SR & MR –Left shift towards reduced late loss for TAXUS SR & MR –Tighter frequency distribution for TAXUS vs. Control TAXUS lower frequency of high late loss Negative Late loss Similar to Control TAXUS SR 0.30 + 0.36 TAXUS MR 0.26 + 0.34 Control 0.78 + 0.47

24. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Stent segment Incompete Apposition

25. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Fates of Incomplete Apposition Baseline Incomplete Apposition Baseline Incomplete Apposition Preserved Incomplete Apposition Preserved Incomplete Apposition Healed/Resolved Incomplete Apposition Healed/Resolved Incomplete Apposition

26. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Follow-up IA (+ remodeling) Baseline Follow-up IA (remodeling) Follow-up IA (remodeling) Follow-up IA (no remodeling) Follow-up IA (no remodeling)

27. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Incomplete Apposition in TAXUS II Summary Late acquired mal-apposition Incidence of 5.3% in control (bare stent) Incidence in TAXUS (SR 8.5% & MR 9.6%) not significantly different from control No correlation with MACE incidence Late acquired mal-apposition Incidence of 5.3% in control (bare stent) Incidence in TAXUS (SR 8.5% & MR 9.6%) not significantly different from control No correlation with MACE incidence

28. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 TAXUS Angiographic Aneurysm Incidence Summary SR Cohort n=4 SR Cohort n=4 MR Cohort n=4 MR Cohort n=4 TAXUS Control 3 128 3 128 1 134 1 134 TAXUS Control 1 128 1 128 3 130 3 130 Incidence (%) 2.3 0.7 0.8 2.3 Diabetics (%) 0.0

29. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Comparative IVUS & QCA TAXUS II For TAXUS SR & MR vs. Combined Control IVUS >60% improvement IVUS volumetric indices Stable vessel & stent volumes comparable to control QCA Binary Restenosis Rates reduced Improvements of at least 60% for all RVDs Optimal placement may reduce confounding restenosis (gap & bare stents) QCA parameters  by 40%-60% for MLD & Late Loss Beneficial edge effect by MLD & LL Beneficial improvements for Diabetics No significant differences in excellent outcomes between TAXUS SR & TAXUS MR IVUS >60% improvement IVUS volumetric indices Stable vessel & stent volumes comparable to control QCA Binary Restenosis Rates reduced Improvements of at least 60% for all RVDs Optimal placement may reduce confounding restenosis (gap & bare stents) QCA parameters  by 40%-60% for MLD & Late Loss Beneficial edge effect by MLD & LL Beneficial improvements for Diabetics No significant differences in excellent outcomes between TAXUS SR & TAXUS MR

30. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Key practice messages Drug eluting stents will reduce (but not abolish) restenosis within the stent but… Must optimise stent deployment Must cover all the atheroma (mind the edges) Do not leave gaps between stents (overlap not a problem) Don’t mix your stents (Drugs & bare metal might not mix) Drug eluting stents will reduce (but not abolish) restenosis within the stent but… Must optimise stent deployment Must cover all the atheroma (mind the edges) Do not leave gaps between stents (overlap not a problem) Don’t mix your stents (Drugs & bare metal might not mix)

31. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Key practice messages More IVUS / pressure wire assessment More IIb/IIIa Inhibitor use Longer stented segments particularly in small vessels and diabetics -Taxus 6 More IVUS / pressure wire assessment More IIb/IIIa Inhibitor use Longer stented segments particularly in small vessels and diabetics -Taxus 6

32. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Taxus 6 Lesions - >18 mm and <40mm length –Randomised 1:1 with bare stents –>2.5m and <3.75 diameter –De Novo Lesions –Express stent –Moderate release polymer –9 month QCA and IVUS follow up Lesions - >18 mm and <40mm length –Randomised 1:1 with bare stents –>2.5m and <3.75 diameter –De Novo Lesions –Express stent –Moderate release polymer –9 month QCA and IVUS follow up

33. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Taxus 6 47 centres in Europe Co-PI, Prof Grubbe and Dr K Dawkins 448 pts enrolled Dec 28 th 2002 –Banning/Channon 28 pts –Dawkins 19 pts –Thomas 7 pts –Adam DeBelder 5 pts –United Kingdom 13% total study 47 centres in Europe Co-PI, Prof Grubbe and Dr K Dawkins 448 pts enrolled Dec 28 th 2002 –Banning/Channon 28 pts –Dawkins 19 pts –Thomas 7 pts –Adam DeBelder 5 pts –United Kingdom 13% total study

34. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916 Acknowledgements Co investigator - Prof Keith Channon Medical study team –C McKenna, G Niccoli, P Heck, F Khan, –D Nicholson Cath lab, cardiology ward and DCU –Nurses, techs, radiographers (N Searle) –K Lucas Colleagues referred pts –(OO, DS, JB, MH, DL, MP, RC-W) Co investigator - Prof Keith Channon Medical study team –C McKenna, G Niccoli, P Heck, F Khan, –D Nicholson Cath lab, cardiology ward and DCU –Nurses, techs, radiographers (N Searle) –K Lucas Colleagues referred pts –(OO, DS, JB, MH, DL, MP, RC-W)

35. TCT 2002 Scientific SessionTAXUS NIRx Comparative Clinical - Version 3.02 RE 20020916