For distribution in the USA only. Trademarks may be registered and are the property of their...

For distribution in the USA only. Trademarks may be registered and are the property of their respective owners. © 2013 Medtronic, Inc. All rights reserved. UC201304600aEN 02/2013

Resolute IntegrityTM Zotarolimus-Eluting Stent System

The Diabetic Patient and Long Lesions

<SPEAKER>


Established Components

• Integrity™ cobalt alloy stent

• MicroTrac™ delivery system

• Zotarolimus antiproliferative drug

Unique Polymer Technology

• BioLinx™ polymer is a unique blend of three polymers to control drug release, support biocompatibility and enhance elution rate

• Drug-release kinetics: complete elution by 180 days

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Resolute Integrity™ DESSystem Components

Udipi K, et al. EuroIntervention. 2007; 3:137-9Meredith IT, et al. J Am Coll Cardiol Intv. 2009; 2:977-85Meredith IT, et al. EuroIntervention. 2007; 3:50-53


Integrity™ Platform

Sinusoid-Formed Wire Helical Wrap Laser-Fusion

• A single, continuous piece of wire is taken and formed into the sinusoidal shape.

A new manufacturing method for modular stent design applied in the Integrity™ BMS and Resolute Integrity™ DES.

• It is then wrapped around a mandrel to give the cylindrical shape of the stent.

• The stent is then fused in strategic locations to ensure maximum flexibility and conformability, without the risk of unraveling.

Continuous Sinusoid Technology



Continuous sinusoid technology will flex continually

Flex

Stiff

FlexStiff

Separate stiff segments connected by flexible connectors limit range

of motion

Note: Image of stents mounted on a wire over an 115°bend. Variation in bend of individual stents is a result of stent & delivery system design.

115° Bend

Flex

StiffStiff

StiffStiffFlex

Flex


Element™ Platform

Multi-link™ 8 Platform

Continuous sinusoid technology allows for continuous flex, which is not possible with laser-cut stents

Continuous sinusoid technology allows for continuous flex, which is not possible with laser-cut stents

Sinusoidal Design Allows for Continuous Flexibility


Resolute Integrity™ ZES

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Based on 3D tracking bench test data on file at Medtronic, Inc.

Lo

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… And Improved Deliverability

Resolute Integrity™ DES2.50 mm x 18 mm

Xience Prime™ DES2.50 mm x 18 mm

Promus Element™ DES2.50 mm x 20 mm

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Resolute™ DES Clinical Evidence

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Enrollment Complete - In Follow Up

RESOLUTE1 Non-RCT First-in-Human (R=139)Non-RCT First-in-Human (R=139) 5 yr

RESOLUTE AC2,3 1:1 RCT vs. Xience V (R=1140; X=1152)1:1 RCT vs. Xience V (R=1140; X=1152) 3 yr

Non-RCT Observational (R=2349)Non-RCT Observational (R=2349) 3 yr

2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402)2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402) 2 yrRESOLUTE US5

2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control2.5 – 3.5 mm Non-RCT (R=100) vs. Hx ControlRESOLUTE Japan 2 yr

R Japan SVS 2.25 Non-RCT vs. PG (R=65)2.25 Non-RCT vs. PG (R=65) < 1yr

38 mm sub-study Non-RCT vs. PG (R=114)38 mm sub-study Non-RCT vs. PG (R=114) < 1yr

RESOLUTE Asia Non-RCT Observational (R=312)Non-RCT Observational (R=312) 1yr

RI-US Registry Post-approval study (R=230)Post-approval study (R=230) enrolling

RESOLUTE US

RESOLUTE Global Clinical Program

Enrolling / Planning

1:1 RCT vs. Taxus (R=200; T=200)1:1 RCT vs. Taxus (R=200; T=200)R-China RCT < 1yr

RESOLUTE Int4

1 Meredith IT, et al. EuroIntervention. 2010;5:692-7. 2 Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3 Silber S, et al. Lancet. 2011;377:1241-47. 4 Neumann FJ, et al. EuroIntervention. 2012;7(10):1181-8. 5 Yeung AC, et al. JACC. 2011;57:1778-83.

R-China Registry Non-RCT Observational (R=1800)Non-RCT Observational (R=1800) < 1yr


RESOLUTE All Comers

17 European sites2300 patients randomized 1:1

Subsets: QCA 460 pts (20%); OCT 50 pts (2%)100% monitoring

30d 6mo 4yr3yr2yr12mo 13mo 5yr

Clinical endpoints

Angio/OCT endpoints

Co-PIs: Profs. Serruys, Silber, WindeckerCo-PIs: Profs. Serruys, Silber, Windecker

Clinical Trial Design

Open label, non-inferiority trialAny patient with symptomatic coronary artery

disease eligible for DES implantation(no lesion/vessel limitations)

Open label, non-inferiority trialAny patient with symptomatic coronary artery

disease eligible for DES implantation(no lesion/vessel limitations)

Resolute™ Stentn = 1,150

Resolute™ Stentn = 1,150

Xience V™ Stentn = 1,150

Xience V™ Stentn = 1,150

Primary Endpoint: • 12-month target lesion failure (TLF), composite of cardiac death, target vessel MI & clinically driven TLRSecondary Endpoints:• Clinical: Patient composite of any death, any MI, & any repeat revascularisation• QCA (powered): 13-month in-stent % diameter stenosis• QCA: % diameter stenosis, late loss, and binary restenosisDrug Therapy: ASA and clopidogrel/ticlopidine > 6mo (per guidelines)

Primary Endpoint: • 12-month target lesion failure (TLF), composite of cardiac death, target vessel MI & clinically driven TLRSecondary Endpoints:• Clinical: Patient composite of any death, any MI, & any repeat revascularisation• QCA (powered): 13-month in-stent % diameter stenosis• QCA: % diameter stenosis, late loss, and binary restenosisDrug Therapy: ASA and clopidogrel/ticlopidine > 6mo (per guidelines)

Serruys PW, et al., N Engl J Med. 2010;363(2):136-46


RESOLUTE All Comers

Resolute ZES(N = 1140)

Xience V EES(N = 1152) P value

Age (yr) 64.4 ± 10.9 64.2 ± 10.8 0.70

Men (%) 76.7 77.2 0.80

Diabetes mellitus (%) 23.5 23.4 1.00

IDDM 8.4 7.1 0.28

ACS (%) 48.3 47.7 0.80

AMI (within 12 hr) (%) 15.4 17.8 0.13

AMI (within 72 hr) (%) 28.9 28.8 0.96

Multivessel disease (%) 58.4 59.2 0.73

Lesions treated per patient 1.5 ± 0.7 1.5 ± 0.8 0.46

Small vessel (RVD ≤2.75 mm) 67.8 67.4 0.88

Long lesion (length >18 mm) 18.2 21.2 0.11

Bifurcation/trifurcation (%) 16.9 17.7 0.62

Total occlusion (%) 16.3 17.2 0.61

In-stent restenosis (%) 8.1 8.0 0.94

Complex Patients1 (%) 67.0 65.6 0.51

1Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 µmol/L), lesion length >27 mm, >1 lesion per vessel, lesion with thrombus or TO (preprocedure TIMI = 0).

Baseline Characteristics

Serruys PW, et al., N Engl J Med. 2010;363(2):136-46


Time after Initial Procedure (months)

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5%

15%

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Log rank P = 0.92

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Resolute™ ZES (N = 1140)

Xience V™ EES (N = 1152)

Primary endpointPnon-inferiority <0.001

8.3%8.2%

Serruys PW, et al., N Engl J Med. 2010;363(2):136-46.Target Lesion Failure (TLF) is defined as cardiac death, TVMI, or clinically driven TLR.

Target Lesion Failure to 3 YearsRESOLUTE All Comers


Time after Initial Procedure (months)

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Log rank P = 0.65HR 1.05 [0.84, 1.33]

24

Target Lesion Failure to 3 Years

Resolute™ ZES (N = 1140)

Xience V™ EES (N = 1152)

TLF (Target Lesion Failure) is defined as cardiac death, TVMI, or clinically driven TLR.

12.4%13.1%

RESOLUTE All Comers

Windecker S. PCR 2012

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RESOLUTE US




RESOLUTE Int4



5130 Patients in Pooled Analysis


No. at risk

R-ZES 5130 5121 4953 4801 4659

% CI 0.1 1.7 3.3 4.2 4.8

Target Lesion Revascularization to 2 YearsRESOLUTE Pooled Efficacy Analysis

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Time After Initial Procedure (months)

4.86%

8%

3.3

Resolute™ ZES Pooled (N = 5130)

TLR is ischemia driven. *Pooled patient level data from RESOLUTE, R-AC, R-Int, R-US, R-JapanThe RESOLUTE Pooled analysis was not specifically designed or powered for the analysis shown above.

Belardi J. ACC 2012


Resolute™ ZES Pooled (N = 5130)

Stent Thrombosis ARC Definite/Probable to 2 YearsRESOLUTE Pooled Safety Analysis

No. at risk

R-ZES 5130 5122 5013 4934 4833

% CI 0.12 0.72 0.78 0.86 0.93

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0.8

*Pooled patient level data from RESOLUTE, R-AC, R-Int, R-US, R-JapanThe RESOLUTE Pooled analysis was not specifically designed or powered for the analysis shown above.

Belardi J. ACC 2012


RESOLUTE 139

RESOLUTE AC 1140

RESOLUTE Int 2349

RESOLUTE US 1402

RESOLUTE Japan 100

5130 Resolute™ population

Matched cohort diabetic populationN = 878 (standard risk)

Matched cohort is all enrolled diabetic subjects excluding subjects with bifurcation, saphenous vein graft (SVG), ISR, AMI (≤72 hours), left ventricular ejection fraction (LVEF) <30%, an unprotected left main lesion, ≥3 vessels, renal impairment (creatinine ≥ 140µmol/L), total lesion length per vessel >27 mm, ≥2 lesions per vessel , lesion with thrombus, or lesion with total occlusion. Yeung A. ACC 2012

Diabetic Patient Populations

RESOLUTE Pooled Diabetic Analysis

Total diabetic patient populationN = 1535

Standard risk patient cohort pre-specified for FDA indication



Prespecified diabetes analysis designed with FDA for diabetes indication

Performance goal prespecified based on meta-analysis: DIABETES, RAVEL DM, SIRIUS DM, TAXUS IV, SCORPIUS, ENDEAVOR Pooled DM.

Standard risk patient population from Pooled RESOLUTE matched to performance goal patient population

First DES with FDA Indication

Performance Goal Resolute™ DES†

TVF: target vessel failure (cardiac death, TV-MI, and clinically driven TVR)†RESOLUTE matched cohort diabetes pooled analysis (N = 878). Yeung A. ACC 2012

TVF at 12 Months(powered endpoint)

TVF at 12 Months(powered endpoint)

14.5

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12.1

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4.83.4

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TLR Cardiac Death

TVMI ST (ARC Def/Prob)

TLF

Standard Risk Pts – Clinical Outcomes at 24 Months

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RESOLUTE Pooled analysis, Standard risk diabetics (n=861/878)

TVF

TLR is ischemia driven. Resolute Pooled standard risk diabetic analysis was not specifically designed or powered for the endpoints other than TVF.

Yeung A. ACC 2012


Resolute™ ZES: 38mm

Presented by Dr. HiremathTCT 2012


• Diabetic patients with CAD tend to have an increased prevalence of long and diffuse lesions.

• Implantation of drug-eluting stents in long coronary artery lesions is associated with a higher risk for restenosis and stent thrombosis related to the need for multiple and overlapping stents.

• Historical data indicate that the XIENCE PRIME LL™ stent is associated with a 1yr TLF rate of 7.7% in long lesions1. Furthermore a recent publication showed no statistical differences at 1 year between R-ZES and SES for the treatment of long coronary artery lesions2.

1 Costa, M. et al. presented at TCT20112 Ahn, J-M, et al. Circ Cardiovasc Interv. 2012 Oct 9. [Epub ahead of print]

BackgroundRESOLUTE 38mm

Adapted from Hiremath S. TCT 2012












RESOLUTE US




RESOLUTE Int4



2 Trials with Data for 38mm Resolute Stents


RESOLUTE 38mm

RESOLUTE USN = 1402

38mm SubstudyN = 114

38mm SubstudyN = 109

RESOLUTE AsiaN = 312

38 mm SubstudyN = 223

1 Year Follow-upn = 222 (99.6%)

Patient Flowchart

Hiremath S. TCT 2012


% N = 223 pts

Age (yr) 60.9 ± 10.6

Male 78.9

Diabetes mellitus 37.7

IDDM 10.3

Hypertension 74.9

Hyperlipidemia 58.7

Current smoker 18.8

Family history of CAD 37.2

Prior MI 32.4

Prior PCI 27.4

Prior CABG 7.2

Cardiac status:

Stable angina 39.2

Unstable angina 47.4

Myocardial infarction 13.4

Baseline CharacteristicsRESOLUTE 38mm



N = 223 pts,269 lesions

Number of diseased vessels (>50%)Single 46.2

Double 36.3

Triple 17.5

Lesion locationLAD 52.0

LCx 20.2

RCA 44.4

Lesion lengthDiscrete (<10mm) 4.6

Tubular (10-19.9mm) 24.5

Diffuse (> 20mm) 70.9

Branch vessel disease 47.9

B2/C lesion 91.2

Lesion length (mm) 25.22 ± 8.83

RVD (mm) 2.78 ± 0.42

MLD (mm) 0.80 ± 0.36

Pre-procedure % diameter stenosis 71.33 ± 11.61

Lesion & Procedure CharacteristicsRESOLUTE 38mm

QCA measurements may have been made by careful visual estimate, on-line QCA or IVUS. Hiremath S. TCT 2012


%N = 223 patients,

269 lesions

Lesion success(the attainment of <50% residual stenosis of the target lesion using any percutaneous method)

100%

Device success(the attainment of <50% residual stenosis of the target lesion using only the assigned device)

97.0%

Procedure success(the attainment of <50% residual stenosis of the target lesion and no in-hospital MACE)

96.3%

Acute Success RatesRESOLUTE 38mm



RESOLUTE 38mmDual Antiplatelet Therapy (DAPT) Usage

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19.0

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TLF CardiacDeath

TV-MI TLR ST(def/prob)

Clinical Outcomes at 1 Year

RESOLUTE 38mm

Target lesion failure (TLF) is defined as cardiac death, target vessel MI and clinically driven TLR. Primary endpoint of TLF at 12 months was 5.4% with a one-sided 95% upper confidence bound of 8.6%, which was significantly less (P < 0.01) than the performance goal of 19.0%.

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Resolute™ 38mm (n = 222)



RESOLUTE 38mm

% 30 Daysn = 223

6 Monthsn = 223

12 Monthsn = 222

Death (all) 0.4 0.4 0.9

Cardiac 0.4 0.4 0.9

MI (target vessel) 3.6 3.6 3.6

Q Wave 0.9 0.9 0.9

Non Q wave 2.7 2.7 2.7

Cardiac death + target vessel MI 4.0 4.0 4.5

ST Def/Prob (all) 0.9 0.9 0.9

Early (< 30 days) 0.9 0.9 0.9

Late (31-360 days) -- 0 0

TLR 0.9 0.9 1.4

TVR 0.9 1.3 2.7

TLF (cardiac death, TV-MI, TLR) 4.5 4.5 5.4

TVF (cardiac death, TV-MI, TVR) 4.5 4.9 6.8


ST occurred in one patient on day 1 (probable ST) and in a second patient on day 4 (definite ST). TLR and TVR are clinically driven. Hiremath S. TCT 2012


6.0

1.22.4

5.1

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4.3

0.71.4

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2.4

TLRCardiac Death TV-MI

ST (ARC Def/Prob)TLF

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RESOLUTE 38mm – Diabetic Patients

Diabetic, 38mm patients (n = 84)Non-Diabetic, 38mm patients (n = 138)

P = 0.79 P = 0.64 P = 0.52 P = 0.49 P = 0.20

All P-values are adjusted by propensity score for differences in baseline characteristics.TLF (Target Lesion Failure) is defined as cardiac death, TVMI, or clinically driven TLR. Hiremath S. TCT 2012


Conclusions

Stent Design• The Resolute Integrity™ zotarolimus-eluting stent utilizes novel

continuous sinusoid technology (CST). • With CST, a single cobalt alloy wire is formed into a repeating sinusoidal

pattern, wrapped helically and fused to improve conformability, provide greater flexibility and excellent deliverability1

Clinical Outcomes• Resolute™ DES is as safe and effective as Xience V™ DES in an all-comers

population2,3,4

• Pooled analysis showed consistent clinical performance in over 5,000 patients studied5

Diabetic indication• First and only DES FDA-approved for patients with diabetes• Pooled data indicated consistent low adverse events rates with the

Resolute™ stent out to 2 years (4.8% TLR, 0.3% ST) despite the higher risk nature of this patient population6

Long lesions• The 38mm length R-ZES was safe and effective in a selected

population of long lesion patients7

1 Based on bench test data on file at Medtronic, Inc. 2 Serruys PW, et al. N Engl J Med. 2010;363:136-46. 3 Silber S, et al. Lancet. 2011;377:1241-47. 4 Windecker S. PCR 2012 5 Belardi J. ACC 2012 6 Yeung A. ACC 2012 7 Hiremath S. TCT 2012


IndicationsThe Resolute Integrity Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤35 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm.ContraindicationsThe Resolute Integrity Zotarolimus-Eluting Coronary Stent System is contraindicated for use in: • Patients with a known hypersensitivity or allergies to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine, drugs such as zotarolimus, tacrolimus, sirolimus, everolimus or similar drugs or any other analogue or derivative • Patients with a known hypersensitivity to the cobalt-based alloy (cobalt, nickel, chromium and molybdenum) • Patients with a known hypersensitivity to the BioLinx® polymer or its individual components Coronary artery stenting is contraindicated for use in: • Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated • Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery systemWarnings• Please ensure that the inner package has not been opened or damaged as this would indicate the sterile barrier has been breached. • The use of this product carries the same risks associated with coronary artery stent implantation procedures, which include subacute and late vessel thrombosis, vascular complications and/or bleeding events. • This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.Precautions• Only physicians who have received adequate training should perform implantation of the stent. • Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be readily performed. • Subsequent stent restenosis or occlusion may require repeat catheter-based treatments (including balloon dilatation) of the arterial segment containing the stent. The long-term outcome following repeat catheter-based treatments of previously implanted stents is not well characterized. • The risks and benefits of the stent implantation should be assessed for patients with a history of severe reaction to contrast agents. • Do not expose or wipe the product with organic solvents such as alcohol. • When drug-eluting stents (DES) are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the RESOLUTE pivotal clinical trials. • Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications, including more tortuous anatomy, may have an increased risk of adverse events, including stent thrombosis, stent embolization, myocardial infarction (MI), or death • Care should be taken to control the position of the guide catheter tip during stent delivery, deployment, and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage • Stent thrombosis is a low-frequency event that is frequently associated with MI or death. Data from the RESOLUTE clinical trials have been prospectively evaluated and adjudicated using the definition developed by the Academic Research Consortium (ARC).The safety and effectiveness of the Resolute Integrity stent have not yet been established in the following patient populations: • Patients with target lesions which were treated with prior brachytherapy or the use of brachytherapy to treat in-stent restenosis of a Resolute Integrity stent • Women who are pregnant or lactating • Men intending to father children • Pediatric patients • Patients with coronary artery reference vessel diameters of <2.25 mm or >4.20 mm • Patients with coronary artery lesions longer than 35 mm or

requiring more than one Resolute Integrity stent • Patients with evidence of an acute MI within 72 hours of intended stent implantation • Patients with vessel thrombus at the lesion site • Patients with lesions located in a saphenous vein graft, in the left main coronary artery, ostial lesions or bifurcation lesions • Patients with diffuse disease or poor flow distal to identified lesions • Patients with tortuous vessels in the region of the target vessel or proximal to the lesion • Patients with in-stent restenosis • Patients with moderate or severe lesion calcification at the target lesion • Patients with occluded target lesions including chronic total occlusions • Patients with three-vessel disease • Patients with a left ventricular ejection fraction of <30% • Patients with a serum creatinine of >2.5mg/dl • Patients with longer than 24 months of follow-upThe safety and effectiveness of the Resolute Integrity stent have not been established in the cerebral, carotid or peripheral vasculature.Potential Adverse EventsOther risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. These risks (in alphabetical order) may include but are not limited to: • Abrupt vessel closure • Access site pain, hematoma or hemorrhage • Allergic reaction (to contrast, antiplatelet therapy, stent material, or drug and polymer coating) • Aneurysm, pseudoaneurysm, or arteriovenous fistula (AVF) • Arrhythmias, including ventricular fibrillation • Balloon rupture • Bleeding • Cardiac tamponade • Coronary artery occlusion, perforation, rupture or dissection • Coronary artery spasm • Death • Embolism (air, tissue, device or thrombus) • Emergency surgery: peripheral vascular or coronary bypass • Failure to deliver the stent • Hemorrhage requiring transfusion • Hypotension/hypertension • Incomplete stent apposition • Infection or fever • MI • Pericarditis • Peripheral ischemia/peripheral nerve injury • Renal failure • Restenosis of the stented artery • Shock/pulmonary edema • Stable or unstable angina • Stent deformation, collapse, or fracture • Stent migration (or embolization) • Stent misplacement • Stroke/transient ischemic attack • Thrombosis (acute, subacute or late) Adverse Events Related to ZotarolimusPatients’ exposure to zotarolimus is directly related to the total amount of stent length implanted. The actual side effects/complications that may be associated with the use of zotarolimus are not fully known. The adverse events that have been associated with the intravenous injection of zotarolimus in humans include but are not limited to: • Anemia • Diarrhea • Dry skin • Headache • Hematuria • Infection • Injection site reaction • Pain (abdominal, arthralgia, injection site) • RashPlease reference appropriate product Instructions for Use for more information regarding indications, warnings, precautions and potential adverse events.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

For further information, please call and/or consult Medtronic at the toll-free numbers or websites listed.

Resolute DES Safety Information

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