1. Resolute IntegrityTM Zotarolimus-Eluting Stent System
Clinical Program Overview
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2. Topics Resolute DES: System Components RESOLUTE All Comers RESOLUTE US
RESOLUTE Pooled Analysis
Safety
Diabetes
Resolute DES: 38mm substudy

3. Resolute Integrity™ DES Overview
System Components

4. Resolute Integrity™ DES
System Components
Established Components
Unique Polymer Technology
Integrity™ cobalt alloy stent
BioLinx™ polymer is a unique blend of three polymers to control drug release, support biocompatibility and enhance elution rate
MicroTrac™ delivery system
Drug-release kinetics: complete elution by 180 days
100 80 60 40 20
Zotarolimus Release (%) 50
150
200
Days
% eluted
Zotarolimus antiproliferative drug
Udipi K, et al. EuroIntervention. 2007; 3:137-9
Meredith IT, et al. J Am Coll Cardiol Intv. 2009; 2:977-85
Meredith IT, et al. EuroIntervention. 2007; 3:50-53

5. Resolute™ DES Polymer
BioLinx™: a Polymer Specifically Designed for DES
Components of a safe polymer:
Mimics the body’s chemistry
Complete drug elution
Compatible with stent delivery
BioLinx™ polymer system design:
Extended drug elution
Low inflammation1
Minimal thrombotic risk2
Rapid and functional endothelial healing1
A biostable polymer that mimics the cell membrane structure will provide extended drug elution over time while maintaining biocompatibility
1 In porcine models. 2 Based on test data on file at Medtronic, Inc.
Preclinical results may not be indicative of clinical performance of DES 5

6. Drug Elution Comparison to 180 days EES R-ZES SES E-ZES % Drug Eluted
(Xience V™ / Xience PRIME™ /
Promus™ / Promus Element™)
R-ZES
(Resolute Integrity™)
SES
(Cypher™)
E-ZES
(Endeavor™)
% Drug Eluted 20 40 60 80
100
Time (day) 30 90 50 10 70
110
120
150
140
130
170
160
180
PES
(Taxus Liberte™ / Taxus Element™ / ION™)
Source: Medtronic Vascular Data Presentation, TCTMD; TAXUS IV SR Presentation, TCTMD; Cypher Presentation, TCTMD; Data on file at Abbott Vascular.

7. Integrity™ Platform Continuous Sinusoid Technology
A new manufacturing method for modular stent design applied in the Integrity™ BMS and Resolute Integrity™ DES.
Sinusoid-Formed Wire
Helical Wrap
Laser-Fusion
A single, continuous piece of wire is taken and formed into the sinusoidal shape.
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.

8. Integrity™ Platform
Sinusoidal Technology Allows for Continuous Flexibility
Stiff
Flex
Separate stiff segments connected
by flexible connectors limit range
of motion
115° Bend
Flex
Stiff
Element™ platform
Continuous sinusoid technology
will flex continually
Flex
Multi-link 8™ platform
The Integrity stent design features a continuous preferential bending plane
Continuous bending is a trait of the single piece of wire from which the stent is made, and the fusion pattern that follows the pitch of the wire
Laser-cut stents have alternating bending planes between each set of relatively rigid segments, which only allow bending at discrete points along the length of the stent and limit the range of motion
Integrity™ platform
Continuous sinusoid technology allows for continuous flex, which is not possible with laser-cut stents
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.

9. Resolute Integrity™ DES
Deliverability
3D bench test model† 10 20 30 40 50 60 70 80 90
100
20 mm
18 mm
30 mm 60
Average Push Force (gf)
Lower is Better 52 23
Promus Premier™ Plus DES
2.50 mm x 20 mm
Xience Xpedition™ DES
2.50 mm x 18 mm
Resolute Integrity™ DES
2.50 mm x 30 mm
*Based on bench test data on file at Medtronic, Inc. These tests may not be indicative of clinical performance.
†Bench test data vs. Abbott Xience Xpedition™ DES and Boston Scientific Promus Element Plus™ DES on file at Medtronic, Inc.

10. Resolute™ DES Clinical Evidence
Overview of the RESOLUTE Clinical Program

11. RESOLUTE Global Clinical Program
Enrollment Complete - In Follow Up
RESOLUTE1
Non-RCT First-in-Human (R=139)
5 yr
RESOLUTE AC2,3
1:1 RCT vs. Xience V™ EES (R=1140; X=1152)
5 yr
RESOLUTE Int4,5
Non-RCT Observational (R=2349)
3 yr
RESOLUTE US6
2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402)
4 yr
RESOLUTE Japan
2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control
3 yr
R-Japan SVS
2.25 Non-RCT vs. PG (R=65)
2 yr
RESOLUTE US7
38 mm sub-study Non-RCT vs. PG (R=114)
1 yr
R-China RCT8
1:1 RCT vs. Taxus™ PES (R=200; T=200)
1 yr
RESOLUTE Asia7
Non-RCT Observational (R=312)
1 yr
R-China Registry9
Non-RCT Observational (R=1800)
1 yr
Enrolling / Planning
RI-US Registry
Post-approval study (RI≈230)
enrolling
PROPEL
Post-approval study (RI=1200) vs. Hx Control
enrolling
1 Meredith IT, et al. EuroIntervention. 2010;5: Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet. 2011;377:
4 Neumann FJ, et al. EuroIntervention. 2012;7(10): Belardi JA, et al. J Interv Cardiol. 2013;26(5): Yeung AC, et al. JACC. 2011;57:
7Lee M, et al. Am J Cardiol. 2013;112(9): Xu B, et al. JACC Cardiovasc Interv. 2013;6(7): Qiao S, et al. Am J Cardiol doi: /j.amjcard [Epub ahead of print] 11

12. RESOLUTE All Comers Clinical Trial Design
Co-PIs: Profs. Serruys, Silber, Windecker
Open label, non-inferiority trial
Any patient with symptomatic coronary artery disease eligible for DES implantation
(no lesion/vessel limitations)
17 European sites
2300 patients randomized 1:1
Subsets: QCA 460 pts (20%); OCT 50 pts (2%)
100% monitoring
Resolute™ Stent
n = 1150
Xience V™ Stent
n = 1150
Clinical endpoints
30d
6mo
12mo
13mo
2yr
3yr
4yr
5yr
Angio/OCT endpoints
Primary Endpoint:
12-month target lesion failure (TLF), composite of cardiac death, target vessel MI & clinically driven TLR
Secondary 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 restenosis
Drug Therapy: ASA and clopidogrel/ticlopidine > 6mo (per guidelines)
Serruys PW, et al., N Engl J Med. 2010;363(2):136-46

13. RESOLUTE All Comers Baseline Characteristics Resolute DES (N = 1140)
Xience V DES
(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
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
Resolute Integrity DES is not specifically approved for the following patients subsets; bypass graft, LVEF<30%, unprotected LM and renal insufficiency or failure (creatinine>140µmol/L)
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).
Serruys PW, et al., N Engl J Med. 2010;363(2):136-46

14. Pnon-inferiority <0.001
RESOLUTE All Comers
Target Lesion Failure to 5 Years 40
Resolute™ ZES (N = 1140)
Xience V™ EES (N = 1152)
Log rank P = 0.65 30
Primary endpoint
Pnon-inferiority <0.001
8.3%
8.2%
Cumulative Incidence
of TLF (%) 20
17.1%
16.3% 10
In this predominantly complex patient population, both stents remained clinically equivalent through 5 years (TLF 17.1% vs. 16.3%, P = 0.65). 1 2 3 4 5
Time After Initial Procedure (years)
No. at risk
Resolute
1140
1110
1035
992
960
920
Xience V
1152
1122
1031
995
959
926
TLF (Target Lesion Failure) is defined as cardiac death, TVMI, or clinically driven TLR.
Windecker S. PCR 2014

15. RESOLUTE All Comers Target Lesion Failure Components at 5 Years
Resolute™ ZES (n = 1123)
Xience V™ EES (n = 1133)
P = 0.48
P = 0.58
P = 1.00
The components of TLF, cardiac death, target vessel MI and TLR also showed no differences in event rates between the 2 stents.
TLR is clinically driven.
RESOLUTE All Comers was not specifically designed or powered for the analyses shown above.
Windecker S. PCR 2014

16. Time After Initial Procedure (months)
RESOLUTE All Comers
DAPT* Usage over 5 Years
Resolute™ ZES (N = 1140)
Xience V™ EES (N = 1152)
DAPT Usage (%)
In this trial with all-comers patients, only 11-12% were still on DAPT at 5 years, despite the high level of complexity (67% of pts had at least 1 complex characteristic)
12.3%
11.3%
Time After Initial Procedure (months)
* Dual antiplatelet therapy (DAPT) defined as Aspirin and either Clopidogrel or Ticlopidine or Prasugrel or Ticagrelor.
P-value is not significant at all time points. Trend line is for illustrative purposes only and does not represent continuous reporting. The optimal duration of DAPT is unknown and DES thrombosis may still occur despite continued therapy.
Windecker S. PCR 2014

17. RESOLUTE All Comers Stent Thrombosis to 5 Years: Definite / Probable10
Resolute™ ZES (N = 1140)
Xience V™ EES (N = 1152)
Log rank P = 0.22 8 6
ARC Definite/Probable ST (%)
Cumulative Incidence of 4
2.4% 2
1.7%
No significant differences between RZES and EES in terms of ST out to 5yrs, although there was a numerically but not statistically significant higher rate associated with the RZES device. This difference occurred mostly early after the procedure, and a landmark analysis to explore very late ST (ie>1yr) is shown on the next slide. 1 2 3 4 5
Time After Initial Procedure (years)
No. at risk
Resolute
1140
1134
1098
1072
1044
1005
Xience V
1152
1150
1104
1083
1051
1021
RESOLUTE All Comers was not specifically designed or powered for the analysis shown above
Windecker S. PCR 2014

18. RESOLUTE All Comers Very Late Stent Thrombosis: Definite / Probable5
Resolute™ ZES (N = 1140)
Xience V™ EES (N = 1152)
Log rank P = 0.66 4 3
Cumulative Incidence of Very Late
ARC Definite/Probable ST (%) 2
1.03% 1
0.84%
The incidence of very late stent thrombosis is low and similar between Resolute ZES and Xience V EES 1 2 3 4 5
Time After Initial Procedure (years)
No. at risk
Resolute
1111
1085
1057
1018
Xience V
1108
1087
1055
1025
RESOLUTE All Comers was not specifically designed or powered for the analysis shown above
Windecker S. PCR 2014

19. Meta-analysis No significant differences in Definite / Probable ST
Authors conclude that R-ZES has a similar safety and effectiveness profile as compared to EES, with no differences in risks of cardiac death, TV-MI, TVR; and most importantly there were no differences observed in risks of ST.
The presenting physician commented: “This meta-analysis showed that the RAC early ST difference between R-ZES and EES was by chance”.
Stefanini GG. PCR 2014; Safety and efficacy of Resolute Zotarolimus-eluting stents vs. Everolimus-eluting stents: a meta-analysis of 5 randomized trials including 9,899 patients

20. RESOLUTE All Comers Final Conclusions at 5 Years
The follow-up compliance at 5 years was extremely high (98.5%), further supporting the reliability of these long term study outcomes in an all-comer patient population.
In this predominantly complex patient population, both stents remained clinically equivalent through 5 years (TLF 17.1% vs %, P = 0.65).
Despite that only ~10% of patients were on DAPT at 5 years, the incidence of very late stent thrombosis was low and similar between Resolute ZES and Xience V EES (def/prob ST 0.84% vs. 1.03%, P = 0.66).
RESOLUTE All Comers was not specifically designed or powered for stent thrombosis
Windecker S. PCR 2014

21. RESOLUTE Global Clinical Program
Enrollment Complete - In Follow Up
RESOLUTE1
Non-RCT First-in-Human (R=139)
5 yr
RESOLUTE AC2,3
1:1 RCT vs. Xience V™ EES (R=1140; X=1152)
5 yr
RESOLUTE Int4,5
Non-RCT Observational (R=2349)
3 yr
RESOLUTE US6
2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402)
4 yr
RESOLUTE Japan
2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control
3 yr
R-Japan SVS
2.25 Non-RCT vs. PG (R=65)
2 yr
RESOLUTE US7
38 mm sub-study Non-RCT vs. PG (R=114)
1 yr
R-China RCT8
1:1 RCT vs. Taxus™ PES (R=200; T=200)
1 yr
RESOLUTE Asia7
Non-RCT Observational (R=312)
1 yr
R-China Registry9
Non-RCT Observational (R=1800)
1 yr
Enrolling / Planning
RI-US Registry
Post-approval study (RI≈230)
enrolling
PROPEL
Post-approval study (RI=1200) vs. Hx Control
enrolling
1 Meredith IT, et al. EuroIntervention. 2010;5: Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet. 2011;377:
4 Neumann FJ, et al. EuroIntervention. 2012;7(10): Belardi JA, et al. J Interv Cardiol. 2013;26(5): Yeung AC, et al. JACC. 2011;57:
7Lee M, et al. Am J Cardiol. 2013;112(9): Xu B, et al. JACC Cardiovasc Interv. 2013;6(7): Qiao S, et al. Am J Cardiol doi: /j.amjcard [Epub ahead of print] 21

22. De Novo Native Coronary Lesion (≤ 35 mm lesions tx w/ 38 mm stent)
RESOLUTE US
Clinical Study Design
PI: M. Leon, L. Mauri, A. Yeung
De Novo Native Coronary Lesion
Vessel Diameter: 2.25 – 4.2 mm
Lesion Length: ≤ 27 mm
(≤ 35 mm lesions tx w/ 38 mm stent)
Resolute™ stent
2.25–3.5 Clinical (n=1242)
2.25–3.5 Angio/IVUS (n=100)
4.0 Angio (n=60)
38mm Clinical (n=110–175)
Hx Controls
Performance Goals
N = max 1577 patients
Up to 135 US sites
Clinical endpoints
30d
6mo
8mo
9mo
12mo
18mo
2yr
3yr
4yr
5yr
Angio/IVUS endpoints
Primary Endpoints:
2.25–3.5 Clinical → Target Lesion Failure at 12mo
2.25–3.5 Angio/IVUS → In-Stent LLL at 8mo
4.0 Angio → In-Segment LLL at 8mo
38 mm Clinical → Target Lesion Failure at 12mo
Drug Therapy: ASA and clopidogrel/ticlopidine ≥ 6mo (per guidelines)
Mauri L, et al. Am Heart J. 2011;161:

23. RESOLUTE US Baseline Characteristics % All Patients
(2.25 mm – 4.00 mm diameter)
N = 1402 Patients / 1573 Lesions
Age, years (mean ± SD)
64.1±10.7
Male
68.3
Diabetes mellitus
34.4
IDDM
9.6
Prior PCI
32.7
Reason for revascularization:
Stable angina
56.1
Unstable angina
41.9
Myocardial infarction
2.1
LAD
45.9
RVD (mm)
2.6 ± 0.5
Type B2/C lesion
75.2
Two vessel treatment
10.4
Stents per patient (mean ± SD)
1.2 ± 0.5
Stent length per patient (mm)
22.4 ± 10.5
Yeung AC, et al. J Am Coll Cardiol. 2011;57:

24. Cumulative Incidence of TLF (%) Time After Initial Procedure (years)
RESOLUTE US
Target Lesion Failure to 4 Years
R-US All Patients (N = 1402) 30 20
Cumulative Incidence of TLF (%) 10
9.98% 1 2 3 4
Time After Initial Procedure (years)
No. at risk
1402
1384
1302
1233
1183
% CI
1.28
4.68
7.27
8.34
9.98
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.
Lee D. ACC 2014

25. RESOLUTE US Safety and Efficacy Outcomes at 4 Years
R-US All Patients (n=1329/1402)
Events (%) ST
(ARC Def/Prob)
TLF
TLR
Cardiac
Death
TV-MI
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR. TLR is ischemia driven.
Lee D. ACC 2014

26. Time After Initial Procedure (months)
RESOLUTE US, AC, INT
DAPT to 4 Years
97.4
95.9
93.8
R-US (N=1402)
97.3
95.8
91.1
R-International (N=2349)
93.8
R-All Comers (N=1140)
93.1
84.1
65.7
55.4
51.4%
Adherence to DAPT (%)
43.9
34.6%
Interesting observation that US has a much higher long-term DAPT adherence compared to other international studies, despite the fact that both R-AC + R-INT included 2/3 complex patients.
18.6
12.8
13.8%
Time After Initial Procedure (months)
RESOLUTE All-Comers and International trials had very broad eligibility criteria and included approximately 67% complex patients.
R-International trial completed follow-up at 3 yrs.
Lee D. ACC 2014

27. RESOLUTE US Def/Prob Stent Thrombosis to 4 Years 0.38%
R-US All Patients (N = 1402) 5 4 3
Cumulative Incidence of ARC Def/Prob Stent Thrombosis (%) 2 1
0.38% 1 2 3 4
Time After Initial Procedure (years)
No. at risk
1402
1355
1308
1262
% CI
0.00
0.14
0.22
0.29
0.38
RESOLUTE US was not specifically designed or powered for the analysis of stent thrombosis.
Lee D. ACC 2014

28. RESOLUTE US – Diabetic Patients
Safety and Efficacy Outcomes at 4 Years
All Patients (n = 1329/1402)
Diabetic Patients (n = 459/482)
Events [%]
Cardiac
Death ST
(ARC Def/Prob)
TLF
TLR
TV-MI
Target lesion failure (TLF) is defined as cardiac death, target vessel MI and TLR.
TLR is clinically driven.
Ball M. SCAI 2014

29. RESOLUTE US Event rates remained very low out to 4 years:
Conclusions
Event rates remained very low out to 4 years:
The rate of TLF (primary endpoint) was 10%
The incidence of ARC definite or probable stent thrombosis was 0.4%
Similar to other US trials, adherence to DAPT after 12 months remained relatively high with 51% still taking DAPT 4 years after implantation.
These late results from the RESOLUTE US study demonstrated excellent efficacy and safety and support the long term performance of the Resolute stent.
RESOLUTE US was not specifically designed or powered for the analysis of stent thrombosis.
Lee D. ACC 2014

30. RESOLUTE Global Clinical Program
7618 Patients Included in Pooled Analysis
Trial Design
Latest Follow-up
RESOLUTE1
Non-RCT First-in-Human (R=139)
5 yr
RESOLUTE AC2,3
1:1 RCT vs. Xience V™ EES (R=1140; X=1152)
5 yr
RESOLUTE Int4,5
Non-RCT Observational (R=2349)
3 yr
RESOLUTE US6
2.25 – 4.0mm Non-RCT vs. Hx Control (R=1402)
4 yr
RESOLUTE Japan
2.5 – 3.5mm Non-RCT vs. Hx Control (R=100)
4 yr
R-Japan SVS
2.25mm Non-RCT vs. PG (R=65)
2 yr
R-China RCT8
1:1 RCT vs. Taxus™ PES (R=200; T=200)
2 yr
R-US 38mm7
Sub-study Non-RCT vs. PG (R=114)
1 yr
The current analysis of 7618 patients is the largest to date of Resolute patients enrolled in the global clinical program.
All trials with data included in analysis.
This analysis goes out to the longest available followup at 5yrs.
RESOLUTE Asia7
Non-RCT Observational (R=311)
1 yr
R-China Registry9
Non-RCT Observational (R=1800)
1 yr
Enrolling
RI-US Registry
Post-approval study (RI≈230)
PROPEL
Post-approval study vs. Hx Control (RI=1200)
1 Meredith IT, et al. EuroIntervention. 2010;5: Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet. 2011;377:
4 Neumann FJ, et al. EuroIntervention. 2012;7(10): Belardi JA, et al. J Interv Cardiol. 2013;26(5): Yeung AC, et al. JACC. 2011;57:
7Xu B, et al. JACC Cardiovasc Interv. 2013;6(7): Lee M, et al. Am J Cardiol. 2013;112(9): Qiao S, et al. Am J Cardiol doi: /j.amjcard [Epub ahead of print] 30

31. RESOLUTE Pooled Baseline Characteristics % N = 7618 Pts Age (yr)
63.0 ± 11.0
Male
75.4
Diabetes mellitus
30.4
Prior PCI
25.8
Acute coronary syndrome
64.0
B2/C lesion
67.5
Multi-vessel treament
20.5
Reference Vessel Diameter (mm)
2.83 ± 0.52
Lesion length (mm)
18.22 ± 11.28
Total stent length per patient (mm)
33.10 ± 22.59
Complex patient1
46.7
While the complexity of eligible patients varied by study, approximately half of all patients had one or more complex patient or lesion characteristic.
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 total occlusion (preprocedure TIMI = 0).
Di Mario C. PCR 2014

32. Cumulative Incidence of TLF (%) Time After Initial Procedure (years)
RESOLUTE Pooled
Target Lesion Failure (TLF) to 5 Years 30
Resolute ZES Pooled (N = 7618) 25 20
Cumulative Incidence of TLF (%) 15
13.4 10
5.7 5 1 2 3 4 5
Time After Initial Procedure (years)
No. at risk
7618
7532
6603
5081
3951
1924
% CI
1.1
5.7
8.2
9.6
11.4
13.4
TLF is defined as Cardiac Death, TVMI, or clinically indicated TLR.
The RESOLUTE Pooled analysis was not specifically designed or powered for the analysis shown above
Di Mario C. PCR 2014 32 32

33. Cumulative Incidence of TLR (%) Time After Initial Procedure (years)
RESOLUTE Pooled
Target Lesion Revascularization (TLR) to 5 Years 30
Resolute ZES Pooled (N = 7618) 25 20
Cumulative Incidence of TLR (%) 15 10
6.1 5
2.6
Likewise, efficacy event rates measured by TLR remained also very stable through long-term follow-up. 1 2 3 4 5
Time After Initial Procedure (years)
No. at risk
7618
7608
6761
5216
4062
1987
% CI
0.1
2.6
4.0
4.5
5.2
6.1
TLR is ischemia driven.
The RESOLUTE Pooled analysis was not specifically designed or powered for the analysis shown above
Di Mario C. PCR 2014 33 33

34. RESOLUTE Global Clinical Program
DAPT Usage
R-Pooled
(N=7618)
RESOLUTE FIM (N=139)
R-US (N=1402)
R-Asia 38mm (N=109)
R-All Comers (N=1140)
R-Japan (N=100)
R-Asia Dual vessel (N=202)
R-International (N=2349)
R-Japan SVS (N=65)
R-China RCT (N=200)
R-China Registry (N=1800)*
77.8%
72.6%
75.0%
Percent Receiving DAPT
51.4%
48.2%*
39.4%
Significant differences were observed in DAPT adherence between trials, reflective of different clinical practices around the world.
32.8%
34.6%
14.2%
11.0%
Time After Initial Procedure (months)
*R-China Registry 2yr data available in 830/1800 patients
Di Mario C. PCR 2014

35. RESOLUTE Pooled Stent Thrombosis (ARC Def/Prob) to 5 Years 1.17 5
Resolute ZES Pooled (N = 7618) 4 3
Cumulative Incidence of ARC Definite/Probable ST (%) 2
0.67
1.17 1
Although follow-up to 5 years has not yet been obtained in all patients, event rates remained very stable through the long-term follow-up. The rate of very late stent thrombosis (ST>1 yr) remained very low (0.5%) out to 5 years.
In this pooled analysis, we did not observe any concerns of long term safety associated with the Resolute stent. 1 2 3 4 5
Time After Initial Procedure (years)
No. at risk
7618
7610
6908
5425
4244
2087
% CI
0.08
0.67
0.84
0.96
1.08
1.17
The RESOLUTE Pooled analysis was not specifically designed or powered for the endpoints shown above.
Di Mario C. PCR 2014 35 35

36. RESOLUTE Pooled Conclusions
The current analysis of 7618 patients is the largest to date of Resolute patients enrolled in the global clinical program. While the complexity of eligible patients varied by study, approximately half of all patients had one or more complex patient characteristic.
Significant differences were observed in DAPT adherence between trials, reflective of different clinical practices around the world.
Although follow-up to 5 years has not yet been obtained in all patients, event rates remained very stable through the long-term follow-up. In particular, the rate of very late stent thrombosis (ST>1 yr) remained very low (0.5%) out to 5 years.
Long-term follow-up of current generation DES remain critically important to evaluate if there is any increased risk over time of low frequency events. In this pooled analysis, we did not observe any concerns of long term safety associated with the Resolute stent.
The RESOLUTE Pooled analysis was not specifically designed or powered for the endpoints shown above.
Di Mario C. PCR 2014

37. Total diabetic patient population Matched cohort diabetic population
RESOLUTE Pooled Diabetic Analysis
Diabetic Patient Populations
RESOLUTE
139
RESOLUTE AC
1140
RESOLUTE Int
2349
RESOLUTE US
1402
RESOLUTE Japan
100
5130 Resolute population
Total diabetic patient population
N = 1535
Matched cohort diabetic population
N = 878 (standard risk)
Standard risk patient cohort pre-specified for FDA indication
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. Resolute Pooled standard risk diabetic analysis was not specifically designed or powered for the endpoints other than TVF.
Silber S. et al. J Am Coll Cardiol Intv. 2013;6:357– 68. 37

38. RESOLUTE Pooled Diabetic Analysis
First DES with 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
TVF at 12 Months
(powered endpoint)
P = 0.001
14.5
Events (%)
7.8
Performance Goal
Resolute DES†
TVF: target vessel failure (cardiac death, TV-MI, and clinically driven TVR)
†RESOLUTE matched cohort diabetes pooled analysis (N = 878).
Silber S. et al. J Am Coll Cardiol Intv. 2013;6:357– 68.

39. Standard Risk Diabetics N = 878
RESOLUTE Pooled Diabetic Analysis
Baseline Characteristics %
Standard Risk Diabetics N = 878
All Diabetics
N = 1535
Age (yr)
65.2 ± 10.2
65.6 ± 10.2
Male
66.4
68.1
Diabetes mellitus
100.0
IDDM
28.5
29.6
Prior MI
24.9
27.6
Prior PCI
34.6
34.5
Reason for Revascularization:
Stable angina
46.2
39.7
Unstable angina
28.9
26.8
Myocardial infarction
5.4
18.1
LAD
44.8
46.8
RVD (mm)
2.7 ± 0.5
Lesions per patient
1.1 ± 0.4
1.3 ± 0.6
Stent length per patient
22.5 ± 11.3
28.5 ± 18.8
Complex patients*
42.8
* Complex 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).
Yeung A. ACC 2012

40. RESOLUTE Pooled Diabetic Analysis
Standard Risk Pts – Clinical Outcomes at 24 Months
RESOLUTE Pooled analysis,
Standard risk diabetics (n=861/878)
Events (%)
TVF
TLF
TLR
Cardiac
Death
TVMI ST
(ARC Def/Prob)
TLR is ischemia driven.
Resolute Pooled standard risk diabetic analysis was not specifically designed or powered for the endpoints other than TVF.
Silber S. et al. J Am Coll Cardiol Intv. 2013;6:357– 68.

41. RESOLUTE Pooled Diabetic Analysis
Standard Risk Pts – Target Lesion Revascularization to 2 Years
20%
Non-Diabetics (N = 1903)
Non-IDDM (N = 628)
IDDM (N = 250)
15%
Cumulative Incidence of Cardiac Death/TLR
10%
5.4%
6.5% 5%
4.3%
2.6%
3.4%
2.1% 0% 6 12 18 24
Time After Initial Procedure (months)
No. at risk
Non-Diabetics
1903
1900
1859
1809
1763
Non-IDDM
628
627
614
589
579
IDDM
250
236
222
216
Pooled patient level data from RESOLUTE, R-AC, R-Int, R-US, R-Japan.
The RESOLUTE Pooled analysis was not specifically designed or powered for the analysis shown above.
Silber S. et al. J Am Coll Cardiol Intv. 2013;6:357– 68.

42. RESOLUTE Pooled Diabetic Analysis
Standard Risk Pts – Cardiac Death/TVMI to 2 Years
20%
Non-Diabetics (N = 1903)
Non-IDDM (N = 628)
IDDM (N = 250)
15%
Cumulative Incidence of Cardiac Death/TVMI
10%
8.6%
6.0% 5%
3.1%
4.1%
3.9%
2.6% 0% 6 12 18 24
Time After Initial Procedure (months)
No. at risk
Non-Diabetics
1903
1872
1833
1796
1757
Non-IDDM
628
626
613
599
593
IDDM
250
248
232
227
222
Pooled patient level data from RESOLUTE, R-AC, R-Int, R-US, R-Japan.
The RESOLUTE Pooled analysis was not specifically designed or powered for the analysis shown above.
Silber S. et al. J Am Coll Cardiol Intv. 2013;6:357– 68.

43. RESOLUTE Pooled Diabetic Analysis
Standard Risk Pts – ARC Def/Prob Stent Thrombosis to 2 Years
10%
Non-Diabetics (N = 1903)
Non-IDDM (N = 628)
IDDM (N = 250) 8% 6%
Cumulative Incidence of ARC Def/Prob ST 4%
0.80% 2%
0.32%
0.16%
0.80%
0.43% 0%
0.16% 6 12 18 24
Time After Initial Procedure (months)
No. at risk
Non-Diabetics
1903
1902
1876
1842
1806
Non-IDDM
628
627
617
604
598
IDDM
250
240
234
229
Pooled patient level data from RESOLUTE, R-AC, R-Int, R-US, R-Japan.
The RESOLUTE Pooled analysis was not specifically designed or powered for the analysis shown above.
Yeung A. ACC 2012

44. RESOLUTE Pooled Diabetic Analysis
All Diabetic Patients – Clinical Outcomes at 24 Months
RESOLUTE Pooled analysis,
All diabetics (n=1510/1535)
Events (%)
TVF
TLF
TLR
Cardiac
Death
TVMI ST
(ARC Def/Prob)
TLR is ischemia driven.
The Global Resolute Clinical Program was not specifically designed or powered for the analysis shown above.
Yeung A. ACC 2012

45. RESOLUTE Global Clinical Program
2 Trials with Data for 38mm Resolute Stents
Enrollment Complete - In Follow Up
RESOLUTE1
Non-RCT First-in-Human (R=139)
5 yr
RESOLUTE AC2,3
1:1 RCT vs. Xience V™ EES (R=1140; X=1152)
4 yr
RESOLUTE Int4,5
Non-RCT Observational (R=2349)
3 yr
RESOLUTE US6
2.25 – 4.0 mm Non-RCT vs. Hx Control (R=1402)
4 yr
RESOLUTE Japan
2.5 – 3.5 mm Non-RCT (R=100) vs. Hx Control
3 yr
R-Japan SVS
2.25 Non-RCT vs. PG (R=65)
2 yr
RESOLUTE US7
38 mm sub-study Non-RCT vs. PG (R=114)
1 yr
R-China RCT8
1:1 RCT vs. Taxus™ PES (R=200; T=200)
1 yr
The Resolute stent in 38mm length was evaluated in two studies: RESOLUTE US and RESOLUTE Asia.
The analysis on the 38mm subgroup from these studies was predefined and agreed upon with the FDA for obtaining approval of the Resolute 38mm stent length in the US.
RESOLUTE Asia7
Non-RCT Observational (R=312)
1 yr
R-China Registry9
Non-RCT Observational (R=1800)
1 yr
Enrolling / Planning
RI-US Registry
Post-approval study (RI≈230)
enrolling
PROPEL
Post-approval study (RI=1200) vs. Hx Control
enrolling
1 Meredith IT, et al. EuroIntervention. 2010;5: Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet. 2011;377:
4 Neumann FJ, et al. EuroIntervention. 2012;7(10): Belardi JA, et al. J Interv Cardiol. 2013;26(5): Yeung AC, et al. JACC. 2011;57:
7Lee M, et al. Am J Cardiol. 2013;112(9): Xu B, et al. JACC Cardiovasc Interv. 2013;6(7): Qiao S, et al. Am J Cardiol doi: /j.amjcard [Epub ahead of print] 45

46. RESOLUTE 38mm Background
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 TCT2011
2 Ahn, J-M, et al. Circ Cardiovasc Interv. 2012;5(5):633-40
Adapted from Hiremath S. TCT 2012

47. RESOLUTE 38mm Patient Flowchart RESOLUTE US RESOLUTE Asia
38mm Substudy
N = 114
38mm Substudy
N = 109
38 mm Substudy
N = 223
A sub-study of 2 prospective, multicenter clinical trials, RESOLUTE US and RESOLUTE Asia, enrolled together 223 patients with de novo coronary artery lesions amenable to treatment with the 38mm length R-ZES in target lesions of at least 35 mm.
At 1 year only one patient was lost to follow-up.
The primary endpoint was target lesion failure (TLF) at 1 year.
The rate of TLF at 1 year was compared to a performance goal of 19.0% derived from a logistic regression model.
All patients were prescribed dual antiplatelet therapy for a minimum of 6 months.
1 Year Follow-up
n = 222 (99.6%)
Lee M, et al. Am J Cardiol. 2013;112(9):

48. RESOLUTE 38mm Baseline Characteristics % 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
Lee M, et al. Am J Cardiol. 2013;112(9):

49. RESOLUTE 38mm Lesion & Procedure Characteristics N = 223 pts,
269 lesions
Number of diseased vessels (>50%)
Single
46.2
Double
36.3
Triple
17.5
Lesion location
LAD
52.0
LCx
20.2
RCA
44.4
Lesion length
Discrete (<10mm)
4.6
Tubular ( mm)
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
QCA measurements may have been made by careful visual estimate, on-line QCA or IVUS.
Lee M, et al. Am J Cardiol. 2013;112(9):

50. RESOLUTE 38mm Acute Success Rates 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%
Despite the challenges in treating these long lesions, the acute success rates were very high, demonstrating the excellent deliverability of the Resolute Integrity stent also in its 38mm length.
Lee M, et al. Am J Cardiol. 2013;112(9):

51. RESOLUTE 38mm Clinical Outcomes at 1 Year Primary endpoint met
Resolute™ 38mm (n = 222)
Events [%]
The primary endpoint was target lesion failure (TLF) at 1 year. The rate of TLF at 1 year was compared to a performance goal of 19.0% derived from a logistic regression model.
At 1 year, the rate of TLF was 5.4%, thereby meeting the primary endpoint for the 38mm Resolute stent.
Other clinical events rates were low and notably there were no late stent thrombosis events.
TLF
Performance
goal
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%.
RESOLUTE 38mm was not specifically designed or powered for other endpoints than TLF.
Lee M, et al. Am J Cardiol. 2013;112(9):

52. RESOLUTE 38mm Clinical Outcomes at 1 Year 30 Days % n = 223 6 Months
Death (all)
0.4
0.9
Cardiac
MI (target vessel)
3.6
Q Wave
Non Q wave
2.7
Cardiac death + target vessel MI
4.0
4.5
ST Def/Prob (all)
Early (< 30 days)
Late ( days) --
TLR
1.4
TVR
1.3
TLF (cardiac death, TV-MI, TLR)
5.4
TVF (cardiac death, TV-MI, TVR)
4.9
6.8
Other clinical events rates were low (TLR only 1.4%) and notably there were no late stent thrombosis events.
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. RESOLUTE 38mm was not specifically designed or powered for other endpoints than TLF.
Lee M, et al. Am J Cardiol. 2013;112(9): 52

53. RESOLUTE 38mm – Diabetic Patients
Clinical Outcomes at 1 Year
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
Events [%]
In a separate, post-hoc analysis, there were no statistical significant differences observed between patients with and without diabetes mellitus.
Cardiac
Death ST
(ARC Def/Prob)
TLF
TV-MI
TLR
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.
Resolute 38 mm analysis was not specifically designed or powered for the analysis above.
Lee M, et al. Am J Cardiol. 2013;112(9):

54. RESOLUTE 38mm
Conclusions
In sub-study of 2 prospective, multicenter clinical trials, RESOLUTE US and RESOLUTE Asia with patients amenable to treatment with the 38mm length Resolute™ DES
At 12 months, low rate of TLF (5.4%) and no late stent thrombosis
In diabetic patients at 12 months, 2.4% TLR at 1 year
RESOLUTE 38 mm analysis was not specifically designed or powered for analysis in diabetics.
Lee M, et al. Am J Cardiol. 2013;112(9):

55. 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™ EES in an all-comers population2,3,4
Pooled analysis showed consistent clinical performance in over 7,600 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 Resolute™ DES was safe and effective in a selected population of long lesion patients7
1 Based on bench test data on file at Medtronic, Inc Serruys PW, et al. N Engl J Med. 2010;363: Silber S, et al. Lancet.
2011;377: Windecker S. PCR Di Mario C. PCR Silber S. et al. J Am Coll Cardiol Intv. 2013;6:357– 68.
7 Lee M, et al. Am J Cardiol. 2013;112(9):
UC dEN

56. RESOLUTE Clinical Trial Program
Published References
RESOLUTE Trial:
Meredith IT, et al. The next-generation Endeavor Resolute stent: 4-month clinical and angiographic results from the Endeavor Resolute first-in-man trial. EuroIntervention. 2007;3:50-53.
Meredith IT, et al. Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-in-human trial. J Am Coll Cardiol Intv. 2009;2:
Meredith IT, et al. Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trial. EuroIntervention. 2010;5:692-7.
Waseda K, et al. Short- and mid-term intravascular ultrasound analysis of the new zotarolimus-eluting stent with durable polymer results from the RESOLUTE trial. Circ J. 2010;74:
Waseda K, et al. Impact of Polymer Formulations on Neointimal Proliferation After Zotarolimus-Eluting Stent With Different Polymers: Insights From the RESOLUTE Trial. Circ Cardiovasc Interv Jun 1;4(3):
RESOLUTE All Comers Trial:
Serruys PW, et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010;363:
Silber S, et al. Unrestricted randomized use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet. 2011;377:
Taniwaki M, et al. 4-Year Clinical Outcomes and Predictors of Repeat Revascularization in Patients Treated With New-Generation Drug-Eluting Stents – A Report From the RESOLUTE All-Comers Trial. J Am Coll Cardiol. 2014;63:1617–25.
Garg S, et al. The Prognostic Utility of the SYNTAX Score on 1-Year Outcomes After Revascularization With Zotarolimus- and Everolimus-Eluting Stents - A Substudy of the RESOLUTE All Comers Trial. J Am Coll Cardiol Intv. 2011;4:432– 41.
Stefanini G, et al. The Impact of Patient and Lesion Complexity on Clinical and Angiographic Outcomes After Revascularization With Zotarolimus- and Everolimus- Eluting Stents - A Substudy of the RESOLUTE All Comers Trial. J Am Coll Cardiol. 2011;57:2221–32.
Gutiérrez-Chico JL, et al. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011;32(19):
RESOLUTE International Trial:
Neumann F-J, et al. One-year outcomes of patients with the zotarolimus-eluting coronary stent: RESOLUTE International Registry. EuroIntervention 2012;7:
Belardi JA, et al. Real-World Safety and Effectiveness Outcomes of a Zotarolimus-Eluting Stent: Final 3-Year Report of the RESOLUTE International Study. J Interv Cardiol Oct;26(5):
RESOLUTE US Trial:
Mauri L, et al. Rationale and design of the clinical evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the treatment of de novo lesions in native coronary arteries (the RESOLUTE US clinical trial). Am Heart J. 2011;161:
Yeung AC, et al. Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries. J Am Coll Cardiol. 2011; 57:
RESOLUTE Pooled:
Silber S, et al. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2- year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv Apr;6(4):
Richardt G, et al. Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv Sep;6(9):
Lee M, et al. One-year outcomes of percutaneous coronary intervention with the 38-mm resolute zotarolimus-eluting stent. Am J Cardiol Nov 1;112(9):
Caputo R, et al. Performance of the resolute zotarolimus-eluting stent in small vessels. Catheter Cardiovasc Interv Mar 21. [Epub ahead of print].
Silber S, et al. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J Feb 7. [Epub ahead of print].

57. Resolute Integrity ZES Safety Information
Indications
The 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.
Contraindications
The 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 system
Warnings
● 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-up
The safety and effectiveness of the Resolute Integrity stent have not been established in the cerebral, carotid or peripheral vasculature.
Potential Adverse Events
Other 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 Zotarolimus
Patients’ 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) ● Rash
Please 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.
All brand names, product names or trademarks belong to their respective holders.
UC dEN 57 57