TAXUS IV 2-Year Clinical Results The safety and effectiveness of the TAXUS TM Express 2TM Paclitaxel-Eluting Coronary Stent System have been established up to 12 months in the treatment of de novo lesions ≤ 28mm in length in native coronary arteries ≥ 2.5 to ≤ 3.75mm in diameter. Please refer to the directions for use for the clinical experience observed in three clinical studies TAXUS IV, II and I. TAXUS and Express are trademarks of Boston Scientific Corporation or its affiliates. Copyright © 2004 by Boston Scientific Corporation or its affiliates. All rights reserved.

Control (n=652) Study population (n=1,314) 12-month follow-up (n=1,272; 97%) Control (n=633) 2-year follow-up (n=1,238; 94%) Control (n=613) TAXUS IV Clinical Trial: Patient Flow TAXUS Stent (n=662) TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent TAXUS Stent (n=639) TAXUS Stent (n=625)

TAXUS IV Clinical Trial: Baseline Clinical Features Control (n=652) TAXUS Stent (n=662) P- Value Age (yrs)62.1 ± ± Male gender72.4%71.8%0.81 Diabetes mellitus*25.0%23.4% insulin requiring8.3%7.7%0.76 Hypertension69.0%70.5%0.55 Hyperlipidemia65.6%65.0%0.82 Current smoker20.1%23.4%0.16 Prior MI29.9%30.5%0.86 Unstable angina32.7%35.8%0.25 TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with diabetes.

TAXUS IV Clinical Trial: 2-Year Revascularization P< P= P=0.01 P< TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

Δ 11.8% Δ 10.6% Δ 8.3% 94.4% 82.6% 85.1% 95.7% 88.6% 96.9% 1.3% 2.5% TLR-free (%) Days TAXUS Control P< mos. 12 mos. 9 mos. TAXUS IV Clinical Trial: Freedom From TLR to 2 Years TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

TVR-free (%) Days TAXUS Control P< % 78.9% 24 mos. 12 mos. 83.1% 93.1% Δ 10.5% Δ 10.0% Δ 7.4% 9 mos. 87.9% 95.3% TAXUS IV Clinical Trial: Freedom From TVR to 2 Years 3.7% 4.2% TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

MACE-free (%) Days TAXUS ControlP< % 75.1% 24 mos. 12 mos. 79.8% 89.4% Δ 10.2% Δ 9.6% Δ 6.6% 9 mos. 84.9% 91.5% TAXUS IV Clinical Trial: Freedom From MACE to 2 Years 4.1% 4.7% TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

TAXUS IV Clinical Trial: Stent Thrombosis P= % (n=7) 0.8% (n=5) * All within 1-6 months Stent Thrombosis, % TAXUS Stent CONTROL In-Hospital 31 days – 1 Year* Discharge – 30 Days 1 – 2 Years TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

TAXUS Stent N=3 Patient 1 ST day yr old M; 3.5x32 mm stent mid-RCA; fell off ladder; tibiofemoral surgery and lumbar laminectomy; stent thrombosis 10d later Plavix d/c before surg, ASA uncertain Patient 2 ST day yr old M; 2.5x16 mm stent proximal LAD No Plavix, ASA occasional Patient 3 ST day yr old M; 3.5x16 mm stent distal RCA Uncertain compliance Circumstances ASA/Plavix® status TAXUS IV Clinical Trial: Stent Thromboses Between 1 and 2 Years Plavix is a trademark of Sanofi-Synthelabo Corp.

TAXUS IV Clinical Trial: 2-Year Adverse Cardiac Events P=0.67P< P=0.50 P< TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

P< P=0.026 N=212N=203 N=243N=256N=195N=201 P= TAXUS IV Clinical Trial: Subset Data – 2 Year TLR The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery reference vessel diameter less than 2.5mm. TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

P< P=0.009 N=226N=214 N=323N=351N=99N=91 P< The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery in lesions longer than 28mm. TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent TAXUS IV Clinical Trial: Subset Data – 2 Year TLR

TLR (%) Lesion Length (mm) Control TAXUS Stent > < 2.5 RVD (mm) Tertile analysis The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery reference vessel diameter less than 2.5mm or in lesions longer than 28mm. TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent TAXUS IV Clinical Trial: Subset Data – 2 Year TLR

P< P=0.08 N=489N=507 N=163N=155N=54N=51 P= The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with diabetes. TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent TAXUS IV Clinical Trial: Subset Data – 2 Year TLR

P< N=269N=264 N=381 N=396 TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent TAXUS IV Clinical Trial: Subset Data – 2 Year TLR

12 mo 9 mo 24 mo Control 11.3 n=652 P< p< * P<0.0001* N= * N=163 P=0.0005* 17.7* N=54 P=0.0786* 25.4* P<0.0001* N= * P=0.0092* n= P= N=163 P= n=54 P= P= n=214 P< p< N=97 P< P= DiabeticsInsulin Treated Diabetics 9 mo 12 mo 24 mo * N= * N=51 6.1* N= * N=91 Small Vessel <2.5mm Long Lesion >20mm All Patients TLR * N=662 The safety and effectiveness of the TAXUS™ Express® Stent have not been established in patients with coronary artery reference vessel diameter less than 2.5mm, in lesions longer than 28mm or in patients with diabetes. TAXUS IV Clinical Trial: Subset Data % TLR to 24-month * Kaplan-Meier estimate (log-rank) 2 year 9-Month and 12-Month TAXUS IV Clinical Trial TLR calculated as Fischer ITT analysis 5.2 n= n= n= n= n=206 Paclitaxel- Eluting Stent *** TAXUS IV Clinical Trial- TAXUS™ Express® Stent / Control- Express® Stent

At 2-year follow-up, the incremental benefits of having received the TAXUS stent rather than a bare metal stent continue to increase, with no apparent evidence of late catch-up. TAXUS-IV Clinical Trial: 2-Year Conclusion

INDICATIONS The TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions 2.5 to <3.75mm in diameter. CONTRAINDICATIONS Use of the TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System is contraindicated in patients with: Known hypersensitivity to paclitaxel or structurally related compounds. Known hypersensitivity to the polymer or its individual components. Coronary Artery Stenting is contraindicated for use in: Patients in whom antiplatelet and/or anticoagulant therapy is contraindicated. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. WARNINGS To maintain sterility, the inner package should not be opened or damaged prior to use. The use of this product carries the risks associated with coronary artery stenting, including subacute thrombosis, vascular complications, and/or bleeding events. Patients with known hypersensitivity to 316L stainless steel may suffer an allergic reaction to this implant. Potential adverse events (in alphabetical order) which may be associated with the use of a coronary stent in native coronary arteries include but are not limited to: Aneurysm, Arrhythmias, Bleeding complications, Death, Distal Emboli, Emergent CABG, Myocardial Infarction, Myocardial Ischemia, Occlusion, Stent Delivery Failures, Target Lesion Revascularization, Thrombosis, Vascular complications, Vessel Dissection. Potential adverse events not captured above that may be unique to the paclitaxel drug coating: Alopecia, Allergic reaction to the drug or the polymer, Anemia, Blood product transfusion, Gastrointestinal symptoms, Hematologic dyscrasia, Hepatic enzyme changes, Histologic changes in vessel wall, including inflammation, cellular damage or necrosis, Myalgia/Arthralgia, Peripheral neuropathy. The safety and effectiveness of the TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System have not been established in the following patient populations: Women who are pregnant or lactating. Men intending to father children. Pediatric patients. Patients with unresolved vessel thrombus at the lesion site. Patients with coronary artery reference vessel diameters 3.75 mm. Patients with lesions located in the saphenous vein grafts, in the unprotected left main coronary artery, ostial lesions, or lesions located at a bifurcation. Patients with diffuse disease or poor flow distal to the identified lesions. Patients with tortuous vessels (>60 degrees) in the region of the obstruction or proximal to the lesion. Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow. Patients with multiple overlapping stents. Patients with longer than 12 month follow-up. Prior to use, please see the complete “Directions for Use” at for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions. CAUTION Federal law restricts this product to sale by or on the order of a physician. TRADEMARKS TAXUS, Express 2 and Express are trademarks of Boston Scientific Corporation or its affiliates NIR is a trademark of Medinol, Ltd., Jerusalem, Israel.