Product fact sheet details the differentiating features of the Resolute Integrity DES.

1. Medtronic Coronary Stents
–––––
Resolute Integrity™ Stent System
The Resolute Integrity™ stent system is used worldwide to treat coronary artery disease (CAD),
the narrowing and hardening of the blood vessels that nourish the heart. Developed by
Medtronic, this next-generation drug-eluting stent (DES) was approved by the United States
Food and Drug Administration (FDA) for the treatment of CAD and is the first and only DES to
be approved for use in CAD patients who also have diabetes.i CAD is a leading cause of death
in the US, killing almost half a million Americans each year.ii Research shows that people with
diabetes have a two- to three-fold increased
risk for CAD and two- to four-fold higher
CAD morbidity and mortality rates.iii
The Resolute Integrity DES is used in a
minimally-invasive, catheter-based Resolute Integrity DES is the first and only drug-eluting stent
procedure called percutaneous coronary approved by the FDA for CAD patients who also have diabetes.
intervention (PCI), which is an
alternative to open heart surgery. During PCI, an interventional cardiologist inserts a tiny
balloon into the vessel at the site of the narrowing. Crimped tightly on the end of the balloon is
the stent, a tiny mesh cylinder that is coated with a drug designed to prevent the vessel from
renarrowing. When the balloon is inflated, the stent expands in the narrowed artery and the
drug is released over time into the vessel wall. With the stent expanded, the balloon is deflated
and removed. The stent remains in place, providing a scaffold to keep the artery open and
restoring normal blood flow to the heart.
The Resolute Integrity stent system consists of four components:
Continuous sinusoid technology
forms the flexible stent platform.
The MicroTrac™ delivery system
takes the stent to the target lesion and
deploys it by inflating the balloon.
The highly biocompatible
BioLinx® polymer regulates
drug elution and allows healing.
The antiproliferative
drug zotarolimus limits
excessive tissue growth.

2. Several features distinguish the Resolute Integrity DES from other devices on the market. These
include its benefit to treat CAD patients who also have diabetes, as well as its deliverability and
robust clinical program.
Benefit to CAD Patients with Diabetes
Historically it has been difficult to treat CAD patients with diabetes because they tend to have
narrower, more tortuous arteries with more diffuse disease (for example, plaque that is spread
over a longer section within the artery) and persistently elevated blood-sugar levels. All of these
factors can increase the rate of procedural complications and long-term safety risks. As a result,
many such patients have undergone open heart surgery, which is more invasive and requires
longer hospital stays and recovery time compared with stenting procedures.
The Resolute Integrity DES is the first device of its kind to be approved by the FDA for treating
CAD patients who also have diabetes. About 30 percent of the patients in the global RESOLUTE
clinical program had diabetes––a proportion that mirrors current clinical practice and one
adequate to compare the safety and effectiveness data between CAD patients with and without
diabetes. At one-year follow-up in 867 standard-riskiv diabetes patients who participated in the
trials, the Resolute® DES showed low rates of target lesion revascularizationv (3.3%) and stent
thrombosisvi (0.3%), similar to the stent’s performance in patients without diabetes.
The FDA approval in February 2013 of the 34-mm and 38-mm versions of the Resolute Integrity
DES offer physicians a new, longer stent that is designed to treat patients with diffuse disease,
many of whom also have diabetes (nearly 40% of patients with long lesions in the 38-mm
analysis of the RESOLUTE clinical program also had diabetes).x
Deliverability
In this context, deliverability refers to the device’s ability to traverse the patient’s vascular
system and reach the narrowed arterial segment. The 38-mm length of the Resolute Integrity
DES has been shown in bench testing to offer superior deliverability compared with the 18-mm
Xience V® DES and the 20-mm Promus Element™ Plus DES vii––due to an advance in biomedical
engineering called continuous sinusoid technology (CST). Developed by Medtronic engineers,
CST enables each stent to form from a single wire, comparable to a flexible spring. This unique
technology allows for excellent conformabilityviii ––the ability of the stent to conform to the
natural shape of the vessel––and deliverabilityvii, without compromising other important stent
design characteristics like radial and longitudinal strength. CST represents Medtronic’s
platform of the future for all coronary stents.
Robust Clinical Program
The RESOLUTE clinical program involves hundreds of medical centers in more than 25
countries across the globe. It enrolled more than 5000 patients (nearly 30 percent of whom had
diabetes) in a combination of single-arm and randomized trials. In the clinical trial conducted
with US patients (N = 1402), known as RESOLUTE US, the Resolute DES showed powerful
clinical performance across all safety and efficacy endpoints. At one year, patients (n = 1376)
showed low rates of target lesion failure (4.7%), target lesion revascularization (2.8%) and stent
thrombosis (0.1%).ix For the approval of the 34-mm and 38-mm version of the Resolute Integrity
DES, data on 222 patients from the RESOLUTE US and RESOLUTE Asia clinical studies who
had long lesions were reviewed by the FDA. At one year, these patients had a low rate of target

3. lesion failure (5.4%) and among the nearly 40% of these patients who had diabetes, their clinical
outcomes were similar to patients without diabetes.x
Indications, Safety & Warnings
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

4. (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

5. 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:
www.medtronic.com
www.medtronicstents.com
i
RESOLUTE matched cohort compared against prespecified performance goal based on DES meta-analysis. RESOLUTE matched cohort is a
pooled analysis of standard risk patients from the RESOLUTE global clinical program.
ii
Roger VL et al. Heart disease and stroke statistics—2011 update: A report from the American Heart Association.
Circulation. 2011;123:e18–e209. Epub 2010 Dec 15. http://circ.ahajournals.org/content/123/4/e18.full.pdf+html
iii 6
Tan MH. From research to practice/diabetes and coronary heart disease. Diabetes Spectrum. 1999;12(2):80–83.
http://journal.diabetes.org/diabetesspectrum/99v12n2/pg81.htm
iv
Standard risk was defined as excluding the following characteristics: bifurcation, saphenous vein graft (SVG), in-stent restenosis (ISR), acute
myocardial infarction (AMI) within 72 hours, left ventricular ejection fraction (LVEF) of less than 30%, unprotected left main disease,
atherosclerosis in three or more vessels, renal impairment, total lesion length per vessel of greater than 27 mm, two or more lesions per vessel,
lesion with thrombus, or lesion with total occlusion.
v
A repeat procedure to treat the same arterial segment
vi
A blood clot that forms in the stent
vii
Bench test data vs. Abbott Xience V, DES and Boston Scientific Promus Element Plus DES on file at Medtronic, Inc. These tests may not be
indicative of clinical performance.
viii
Montier P et al. Virtual bench testing of new generation coronary stents. EuroIntervention, 2011;7:369–376.
ix
RESOLUTE US was not powered for stent thrombosis.
x
Based on pooled data from RESOLUTE US and RESOLUTE Asia 38-mm subgroup. Subgroup included 84 patients, and was not prespecified
or powered.
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For distribution in the USA only. © 2013 Medtronic, Inc. All rights reserved. Printed in USA. UC201204993aEN 2/13