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The TAXUS™ Paclitaxel-Eluting Stent Program. The safety and effectiveness of the TAXUS ™ Express 2 ™ Stent has not been established in patients with coronary artery reference vessel diameters less than 2.5 mm or in lesions longer than 28 mm or in patients with diabetes. Table of Contents.

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The safety and effectiveness of the TAXUS™ Express2™ Stent

has not been established in patients with coronary artery

reference vessel diameters less than 2.5 mm or in lesions longer

than 28 mm or in patients with diabetes


Table of contents l.jpg
Table of Contents

  • Drug-eluting stent overview

  • Drug-eluting stent benefits

    In your opinion … Part 1

    • Consistently low revascularization rates

      In your opinion … Part 2

    • Excellent safety with desirable healing

      In your opinion … Part 3

    • Ability to treat various patients and lesions

  • What does the future hold?


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Drug-Eluting Stent OverviewFrom Bare Metal to Drug-Eluting Stents

Key Drug-Eluting Stent Characteristics

Key Bare Metal Stent Characteristics

Restenosis Reduction

  • Binary restenosis

  • Dramatic TLR/TVR reduction

  • Consistent performance throughout the target lesion

  • Predictable results across all patient subsets

  • Desirable late loss

  • Complete endothelialization

  • Wide margin of safety

Healing

  • Large lumens

  • Various lesion access

  • Excellent conformability

  • Minimize incomplete apposition

  • Deliverability

Deliverability and Conformability


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Drug-Eluting Stent Benefits

  • Reduced angiographic restenosis

  • Reduced clinical restenosis

  • Comparable safety compared to bare-metal stents

  • Improved patient outcomes

  • Positive trends in various lesion subsets

  • Positive trends in various patient populations


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In your opinion ...

  • Which patients should receive drug-eluting stents?

  • What factors are critical to consider when trying to minimize repeat revascularizations?

  • What are the most important components of a drug-eluting stent and why?


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TAXUS IV Clinical TrialTLR Overall at 9 Months

RR=0.39 [0.26-0.59]

P<0.0001

RR=0.27 [0.16-0.43]

P<0.0001

Event %

P=0.48

*= Express® Control Stent. **= TAXUS™ Express® Stent


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TAXUS IV Clinical TrialTLR Overall at 12 Months

RR=0.41 [0.29-0.57]

P<0.0001

RR=0.29 [0.19-0.43]

P<0.0001

P=0.74

Event %

*= Express® Control Stent. **= TAXUS™ Express® Stent


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TAXUS IV Clinical Trial TLR/TVR Overall at 9 Months

P<0.0001

P<0.0001

P=0.0008

P<0.0001

P=0.0001

P=0.005

Event %

*= Express® Control Stent. **= TAXUS™ Express® Stent


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TAXUS IV Clinical Trial TLR/TVR Overall at 12 Months

P<0.0001

P<0.0001

P=0.0003

P<0.0001

P<0.0001

P=0.0120

Event %

*= Express® Control Stent. **= TAXUS™ Express® Stent


Impact of diabetes mellitus taxus iv clinical trial tlr at 9 months l.jpg

N=489

N=507

N=109

N=104

N=54

N=51

Impact of Diabetes MellitusTAXUS IV Clinical Trial TLR at 9 Months

P=0.004

P=0.32

P<0.0001

*= Express® Control Stent. **= TAXUS™ Express® Stent


Impact of diabetes mellitus taxus iv clinical trial tlr at 12 months l.jpg

N=489

N=507

N=109

N=104

N=54

N=51

Impact of Diabetes MellitusTAXUS IV Clinical Trial TLR at 12 Months

P=0.12

P<0.0001

P=0.0063

*= Express® Control Stent. **= TAXUS™ Express® Stent


Impact of vessel diameter qca taxus iv clinical trial tlr at 9 months l.jpg

N=214

N=206

N=241

N=257

N=195

N=197

Impact of Vessel Diameter (QCA)TAXUS IV Clinical Trial TLR at 9 Months

P<0.0001

P=0.0004

P=0.057

RVD (mm)

*= Express® Control Stent. **= TAXUS™ Express® Stent


Impact of rvd visual assessment taxus iv clinical trial tlr at 9 months l.jpg

N=154

N=150

N=498

N=511

Impact of RVD (visual assessment)TAXUS IV Clinical Trial TLR at 9 Months

P=0.0001

P<0.0001

*= Express® Control Stent. **= TAXUS™ Express® Stent


Impact of stent diameter taxus iv clinical trial tlr at 9 months l.jpg

N=133

N=131

N=304

N=323

N=206

N=197

Impact of Stent DiameterTAXUS IV Clinical Trial TLR at 9 Months

P=0.0001

P=0.0002

P=0.002

Stent diameter (mm)

*= Express® Control Stent. **= TAXUS™ Express® Stent


Impact of lesion length qca taxus iv clinical trial tlr at 9 months l.jpg

N=226

N=214

N=325

N=351

N=97

N=91

Impact of Lesion Length (QCA)TAXUS IV Clinical Trial TLR at 9 Months

P=0.0009

P=0.0001

P=0.01

Lesion length (mm)

*= Express® Control Stent. **= TAXUS™ Express® Stent


Impact of total stent length taxus iv clinical trial tlr at 9 months l.jpg

N=382

N=372

N=127

N=134

N=153

N=126

Impact of Total Stent LengthTAXUS IV Clinical Trial TLR at 9 Months

P<0.0001

P=0.0004

P=0.002

Stent length (mm)

*= Express® Control Stent. **= TAXUS™ Express® Stent


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Lesion Length Response (tertile analysis)TAXUS IV Clinical Trial TLR at 9 Months

Control

TAXUS™

Stent

TLR (%)

< 2.5

2.5-3.0

> 3.0

RVD (mm)

Lesion Length (mm)


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TAXUS IV Clinical Trial Restenosis at 9 Months

RR=0.30 [0.19, 0.46]

P<0.0001

RR=0.23 [0.13, 0.38]

P<0.0001

Restenosis (%)

*= Express® Control Stent. **= TAXUS™ Express® Stent


Taxus iv clinical trial restenosis impact of vessel diameter qca l.jpg

N=78

N=98

N=97

N=105

N=92

N=88

TAXUS IV Clinical Trial RestenosisImpact of Vessel Diameter (QCA)

P<0.0001

P=0.0001

In-Segment Restenosis (%)

P=0.10

RVD (mm)

*= Express® Control Stent. **= TAXUS™ Express® Stent


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N=49

N=57

N=125

N=143

N=93

N=91

TAXUS IV Clinical Trial RestenosisImpact of Stent Diameter

P=0.0002

P<0.0001

In-Segment Restenosis (%)

P=0.13

Stent diameter (mm)

*= Express® Control Stent. **= TAXUS™ Express® Stent


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Reduced In-Stent Binary Restenosis No Edge Effect in TAXUS IV Clinical Trial

P<0.001

P<0.001

26.6

24.4

% of patients

P=0.81

P=0.27

7.9

5.5

3.4

2.7

1.9

0.7

Intent-to-treat, angiographic subset (n=732)

*= Express® Control Stent. **= TAXUS™ Express® Stent


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9-Month % Diameter Stenosis Improved In-Stent and at Both Edges in TAXUS IV Clinical Trial

P<0.0001

P<0.0001

39.8

37.2

% Diameter Stenosis

26.3

P=0.0167

P=0.0001

17.4

16.1

13.2

11.8

7.6

Intent-to-treat, angiographic subset (n=732)

*= Express® Control Stent. **= TAXUS™ Express® Stent


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9-12mm

9-12mm

0-3mm

0-3mm

3-6mm

3-6mm

6-9mm

6-9mm

12-15mm

12-15mm

TAXUS II Clinical TrialUniform Suppression of Neointima at 6 Months

IVUS analysis of TAXUS II clinical trial patients showed uniform neointimal suppression throughout the entire stent

Control*

3.0

P=ns

TAXUS™ Stent**

2.0

Neointimal hyperplasia area [mm2]

P=ns

1.0

distal

proximal

proximal

0.0

distal

*= Express® Control Stent. **= TAXUS™ Express® Stent


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9-12mm

9-12mm

0-3mm

0-3mm

3-6mm

3-6mm

6-9mm

6-9mm

12-15mm

12-15mm

TAXUS IV Clinical Trial Uniform Suppression of Neointima at 9 Months

IVUS analysis of TAXUS IV clinical trial patients showed uniform neointimal suppression throughout the entire stent

4

Control*

3

P=ns

TAXUS™ Stent**

Neointimal area (mm2)

2

P=ns

1

0

distal

distal

proximal

proximal

*= Express® Control Stent. **= TAXUS™ Express® Stent


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Restenosis ReductionFormula for Fighting Restenosis

Several drug-eluting stent characteristics may contribute to restenosis reduction.

Multifunctional Effects

  • The multifunctional effects of a drug may contribute to reducing restenosis

Uniform Drug Delivery

  • Polymeric coatings may provide uniform drug delivery across the stent

Rapid Drug Absorption

  • High degrees of lipophilicity may increase vascular absorption in the tissue surrounding the stent

Balloon Overhang

  • Minimal overhang may potentially reduce trauma at the edges


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Restenosis ReductionMultifunctional Activity

The TAXUSTM Stent elutes paclitaxel, a multifunctional microtubular inhibitor.

  • Paclitaxel is believed to have multifunctional effects which reduce:

    • Inflammation

    • Proliferation and migration of smooth muscle cells

    • Extra-cellular matrix secretion

Microtubule Network:

Paclitaxel promotes the formation of stable microtubules, thereby inhibiting multiple cellular functions

Note: Image Courtesy of Dr. Vladimir Rodionov


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Paclitaxel

Taxol

Paclitaxel +

Composition

100% Paclitaxel

Cremophor EL +

Dehydrated alcohol

Delivery

Elution from stent

Intravenous

3,280 µg/kg ovarian CA

Dose

1. 5 µg/kg*

- 4,250 µg/kg in breast CA

Indication

Restenosis

Cancer

Restenosis ReductionPaclitaxel andTaxol are Different

* Based on Implantation of a Single 3.5mm X 16mm TAXUS™ Express2™Stent with Total Loaded Dose of 108 g. Dose in g/kg Calculated Using Average Body Surface Area of 1.7m2 and 70kg Body Weight. Note: Taxol is a registered trademark of Bristol Meyers Squibb.


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PaclitaxelWide Safety Window

Paclitaxel’s broad safety window inhibits smooth muscle cell proliferation & migration while allowing the vessel to heal.


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HealingPaclitaxel

Endothelial cells are less sensitive than smooth muscle cells to the effects of paclitaxel.

  • Paclitaxel is a multi-functional drug which appears to:

    • Inhibit proliferation

    • Inhibit migration

    • Inhibit inflammation

    • Inhibit secretion

Restenosis

Prevents

Endothelialization

Promotes

  • The TAXUS™ paclitaxel-eluting stent appears not to delay endothelialization

Complete endothelialization of a paclitaxel-eluting stent in a porcine coronary artery.


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Restenosis ReductionUniform Drug Distribution

The TransluteTM Polymer provides protection and controlled release of paclitaxel.

Translute Polymer is intended to protect the drug during crimping, packaging, distribution, preparation, sterilization, delivery to the lesion, and stent expansion

Translute Polymer is intended to control the release of the drug during the critical period of the restenotic cascade


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Restenosis ReductionLipophilicity

Paclitaxel is highly lipophilic which may increase vascular absorption in tissue surrounding the stent.

Outside the cell

Paclitaxel (green)

Lipid

Bi-Layer

Inside the cell


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In controlled clinical studies, use of the TAXUS™ Stent resulted in consistently low revascularization rates across a broad range of patient and lesion types


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In your opinion ... resulted in consistently low revascularization rates across a broad range of patient and lesion types

  • How do you define “safety” as it relates to drug-eluting stents?

  • Do you believe that late loss is an indication of efficacy, safety or both?

  • How important is late loss?

  • What affects vascular healing after stent implantation?


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TAXUS IV Clinical Trial resulted in consistently low revascularization rates across a broad range of patient and lesion types9-Month MACE and TVF

P=0.80

P=0.88

P<0.0001

P<0.0001

P=0.0002

P=0.0001

Event (%)

*= Express® Control Stent. **= TAXUS™ Express® Stent


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TAXUS IV Clinical Trial resulted in consistently low revascularization rates across a broad range of patient and lesion types12-Month MACE and TVF

P=1.00

P=0.33

P<0.0001

P<0.0001

P<0.0001

P<0.0001

Event (%)

*= Express® Control Stent. **= TAXUS™ Express® Stent


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TAXUS IV Clinical Trial resulted in consistently low revascularization rates across a broad range of patient and lesion typesStent Thrombosis at 12 Months

In-hospital

Discharge - 30 days

31 days - 6 months

12 months

TAXUS™

Stent**

0.6%

(n=4)

0.3

0.3

P=0.75

(n=662)

Control*

0.3

0.3

0.2

0.8%

(n=5)

(n=652)

0

0.2

0.4

0.6

0.8

1

Stent thrombosis, %

Note: There were no additional stent thrombosis between 6 and 9 months in

either the TAXUS Stent or Control.

*= Express® Control Stent. **= TAXUS™ Express® Stent


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Healing resulted in consistently low revascularization rates across a broad range of patient and lesion typesLate Loss

Late loss provides evidence of healing

  • A drug-eluting stent should not completely eliminate the body’s healing response

  • Neointima indicates healing after drug-eluting stent implantation

  • Consistently low but positive late loss values across studies may indicate healing

Image Courtesy of Dr. Robert Schwartz


Healing late loss in bare metal stents l.jpg

MLD resulted in consistently low revascularization rates across a broad range of patient and lesion typesfollow-up

MLD post-procedure

HealingLate Loss in Bare Metal Stents

  • Late loss in bare metal stents is typically 1.0mm

  • Late loss is thought to be largely comprised of neointima

  • Late loss is nearly always a positive number, indicating the lumen decreases in size

0.50mm

Late Loss

1.0mm

+

0.50mm

Illustrations by Boston Scientific. Images not to scale.


Healing late loss in bare metal stents40 l.jpg

MLD resulted in consistently low revascularization rates across a broad range of patient and lesion typesfollow up

HealingLate Loss in Bare Metal Stents

  • The Express2™ Stent strut thickness is 0.0052”, which converts to 0.13mm

  • This is well within the amount of late loss of a bare metal stent, suggesting complete stent strut coverage

Lumen

Neointima

0.50mm

0.13mm

0.0052”= 0.13mm

Illustrations by Boston Scientific. Images not to scale.


Healing taxus iv clinical trial late loss to strut thickness relationship l.jpg

MLD resulted in consistently low revascularization rates across a broad range of patient and lesion typesfollow up

HealingTAXUS IV Clinical Trial Late Loss to Strut Thickness Relationship

  • The Express2™ Stent strut thickness is 0.0052”, which converts to 0.13mm

  • Based on the TAXUS IV trial late loss values, neointima would be sufficient to completely cover the stent struts.

Lumen

Neointima

0.195mm

0.130mm

0.0052”= 0.13mm

Illustrations by Boston Scientific. Images not to scale.


Healing paclitaxel selective impact l.jpg

Low but positive late loss provides evidence that vessel healing has occurred.

Late loss =~0.30mm

0.15 mm

0.15 mm

0.30 mm

HealingPaclitaxel Selective Impact

Paclitaxel allows healing to occur within the vessel, as evidenced by low but positive late loss.

  • Endothelial cells are less sensitive than smooth muscle cells to the effects of Paclitaxel.

Paclitaxel IC50 (nM)

Note: Image courtesy of Dr. Robert Schwartz; In vitro cell culture study performed by Dr. Luszher


Taxus iv clinical trial late loss as a predictor of tlr l.jpg

Late loss <0.6 mm healing has occurred.

weak predictor of TLR

Late loss >0.6mm increasing probability of TLR

TAXUS IV Clinical TrialLate loss as a Predictor of TLR

Logistic regression combining all patients

100

Probability

for TLR (%)

50

0

0.00

0.50

1.00

1.50

2.00

2.50

Late Loss (mm)


Taxus iv clinical trial late loss as a predictor of restenosis l.jpg
TAXUS IV Clinical Trial healing has occurred.Late loss as a Predictor of Restenosis

Logistic regression combining all patients

100

Late loss >0.6 increasing probability of restenosis

Probability for Restenosis (%)

50

0

0.00

0.50

1.00

1.50

2.00

2.50

Late Loss (mm)


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In animal and controlled human clinical studies, the TAXUS™ stent consistently demonstrated excellent safety with desirable healing


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In your opinion ... TAXUS™ stent consistently demonstrated excellent safety with desirable healing

  • What role does the stent platform play in terms of drug-eluting stent safety and efficacy?

  • Why is conformability important with drug-eluting stents?

  • What tradeoffs are you willing to make as it relates to stent designs?


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Deliverability and Conformability TAXUS™ stent consistently demonstrated excellent safety with desirable healing

Excellent deliverability and conformability will continue to be important features with drug-eluting technology…

Bare Metal Stents

(Desired Features)

Drug-Eluting Stents

(Desired Features)

  • Deliverability:

    - access lesions

  • Conformability

  • Deliverability:

    - access more lesions with longer stents when necessary

  • Conformability:

    - provide strut apposition to the vessel for uniform coverage and drug absorption


Stent apposition contributes to efficacy and safety l.jpg

3.0 mm System

Express2™ Stent

Nominal

9 atm

Quarter Size

14 atm

Rated Burst Pressure

18 atm

1.1:1

15 atm

Working Range*

9 atm

Stent apposition contributes to efficacy and safety

  • The Express2 Stent platform was designed for excellent deployment with excellent stent to vessel conformability.

  • A conformable stent provides uniform strut apposition to the vessel wall.


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Importance of Stent Apposition excellent sizing flexibility.

Contact between the vessel wall and the stent strut may be essential for drug absorption.

Uniform stent apposition allows for uniform drug absorption and uniform restenosis reduction.

Incomplete stent apposition / under-deployment may increase the risk of thrombus formation & SAT’s.

Achieving proper stent strut apposition may be a key contributor to both efficacy and safety of drug eluting stents, specifically SATs.

Efficacy (Restenosis Reduction)

Safety (Healing)


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Healing excellent sizing flexibility.Incomplete Apposition Nomenclature


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Incomplete Apposition excellent sizing flexibility.

SafetySub Acute Thrombosis (SAT)

Under - deployment and incomplete apposition increase the risk of SAT

  • A recent study noted that “78% of SAT occurs in arteries with stent under - deployment1,” highlighting the importance of stent deployment and apposition

1Cheneau, et al. Circulation 2003;108;43-47


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TAXUS IV Clinical Trial excellent sizing flexibility.Incomplete Apposition at 9 Months

Control*

TAXUS™ Stent**

P-value

Post-procedure

6.4%(7/109)

11.6%(13/112)

0.24

9 month

3.0%(3/100)

4.0%(4/99)

0.72

Paired data

Resolved

5.4%(5/93)

6.4%(6/94)

1.00

Persistent

1.1%(1/93)

3.2%(3/94)

0.62

Late acquired

2.2%(2/93)

1.1%(1/94)

0.62

*= Express® Control Stent. **= TAXUS™ Express® Stent


Taxus iv clinical trial correlation of incomplete apposition and safety l.jpg

Resolved IA (n=11) excellent sizing flexibility.

Persistent IA (n=4)

Acquired IA (n=3)

MACE overall

0%

0%

0%

Cardiac death

0%

0%

0%

Q-wave MI

0%

0%

0%

Non-Q-wave MI

0%

0%

0%

TVR overall

0%

0%

0%

TLR

0%

0%

0%

Stent thrombosis

0%

0%

0%

TAXUS IV Clinical TrialCorrelation of Incomplete Apposition and Safety

The TAXUS™ Stent showed no safety events at 9 months in patients with resolved, persistent or late acquired IA


Slide54 l.jpg

Excellent deliverability and conformability of the Express excellent sizing flexibility.® stent platform makes it easy to treat various patient and lesion types


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Drug-Eluting Stent Benefits excellent sizing flexibility.Summary of Ideal Characteristics

  • Sustained TLR and restenosis reduction, within the stent and at the edges

  • Consistent results across patients and lesions

TLR and Restenosis Reduction

Stent

Drug

DES

Deliverability and Conformability

Healing

  • Access to various lesions

  • Strut apposition

  • Low rates of major adverse events

  • Consistently low and desirable late loss

Polymer


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TAXUS excellent sizing flexibility.TM Express2TM Paclitaxel-Eluting Coronary Stent System

INDICATIONS

The TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions <28 mm in length in native coronary arteries >2.5 to <3.75 mm in diameter.

CONTRAINDICATIONS

Use of the TAXUS Express2 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.


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TAXUS excellent sizing flexibility.TM Express2TM Paclitaxel-Eluting Coronary Stent System

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.


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TAXUS excellent sizing flexibility.TM Express2TM Paclitaxel-Eluting Coronary Stent System

The safety and effectiveness of the TAXUS Express2 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 <2.5 mm or >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.


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TAXUS excellent sizing flexibility.TM Express2TM Paclitaxel-Eluting Coronary Stent System

Prior to use, please see the complete “Directions for Use” at www.taxus-stent.com 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 and Express2 are trademarks and Express is a registered trademark of Boston Scientific Corporation or its affiliates.


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