Indications for Use 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 catheterbased treatments ( including balloon dilatation ) of the arterial segment containing the stent . The long-term outcome following repeat catheterbased 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 .
For further information , please call and / or consult Medtronic at the toll-free numbers or websites listed .
www . medtronic . com www . medtronicstents . com
Medtronic , Inc . 3576 Unocal Place Santa Rosa , CA 95403 USA Tel : 707.525.0111
LifeLine Customer Support Tel : 877.526.7890 Tel : 763.526.7890
Product Services
Tel : 888.283.7868 Fax : 800.838.3103
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© 2016 Medtronic . All rights reserved . Medtronic , Medtronic logo and Further , Together are trademarks of Medtronic . TM * Third-party brands are trademarks of their respective owners . All other brands are trademarks of a Medtronic company . For distribution in the USA only . Printed in USA . UC201604672aEN-02 2 / 16
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