Resolute Integrity Coronary Stent System

Indications, Safety, and Warnings

Intended 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 ≤ 27 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 endothelialized 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 27 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 too 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.

Last updated: 17 Feb 2012