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.
Indications, Safety & Warnings Indications The Endeavor® Sprint Zotarolimus-Eluting Coronary Stent Delivery System is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length ≤27 mm in native coronary arteries with reference vessel diameters of ≥2.5 mm to ≤3.5 mm. 1 RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM The Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity System) is a device/drug combination product comprised of the following device components: the Integrity Coronary Stent and MicroTrac delivery systems and a drug component (a formulation of.
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). Potential Adverse Events Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. 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. Contraindications The Endeavor Zotarolimus-Eluting Coronary Stent System is contraindicated for use in:. Patients with a known hypersensitivity to zotarolimus or structurally-related compounds. Patients with a known hypersensitivity to the cobalt-based alloy (cobalt, nickel, chromium, and molybdenum). Patients with a known hypersensitivity to Phosphorylcholine polymer or its individual components. Coronary artery stenting is contraindicated for use in:.
Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy. 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 indicates the sterile barrier has been breached.
The use of this product carries the risks associated with coronary artery stenting, including subacute 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. During guidewire exchange, the wire should be manipulated while under high-quality fluoroscopic observation.
Failure to do so may result in the wire moving into the vessel resulting in damage to the vessel wall. 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 blockage may require repeat dilatation of the arterial segment containing the stent.
The long-term outcome following repeat dilatation of endothelialized stents is not well characterized. Risks and benefits of the stent should be assessed for patients with history of severe reaction to contrast agents. Do not expose or wipe the product with organic solvents such as alcohol or detergents. Stent thrombosis is a low-frequency event that current drug-eluting stent (DES) clinical trials are not adequately powered to fully characterize. Stent thrombosis is frequently associated with myocardial infarction (MI) or death. Data from the ENDEAVOR randomized clinical trials have been prospectively evaluated and adjudicated using both the protocol definition of stent thrombosis and the definition developed by the Academic Research Consortium (ARC), and demonstrate specific patterns of stent thrombosis that vary depending on the definition used. In the ENDEAVOR clinical trials analyzed to date, the differences in the incidence of stent thrombosis observed with the Endeavor stent compared to bare metal stents have not been associated with an increased risk of cardiac death, MI, or all-cause mortality.
Potential Adverse Events Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. 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. Anemia. Application site reaction. 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. Warnings/Precautions. Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis, vascular complications and/or bleeding events. Administration of appropriate anticoagulant, antiplatelet and coronary vasodilator therapy is critical to successful stent implantation and follow-up. Patients allergic to F-562 cobalt-chromium alloy may suffer an allergic reaction to this implant. Only physicians who have received appropriate 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 restenosis may require repeat dilatation of the arterial segment containing the stent.
The long-term outcome following repeat dilatation of endothelialized coronary stents is unknown at present. When multiple stents are required, stent materials should be of similar composition. Placing multiple stents of different materials in contact with each other may increase the potential for corrosion. Data obtained from in vitro corrosion tests using a F562 CoCr alloy stent (Medtronic Driver Coronary Stent) in combination with a 316L stainless steel alloy stent (Medtronic S7 Coronary Stent) do not suggest an increased risk of in vivo corrosion. If the physician encounters difficulty while trying to cross the lesion by direct stenting and determines the lesion to be uncrossable, this patient should be treated per predilatation practice.
The stent (the same stent if undamaged) or a new stent of the same kind should then be advanced and deployed with predilatation. Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stented portion and may cause acute closure of the vessel requiring additional intervention (e.g., CABG, further dilatation, placement of additional stents or other).
Outcomes (beyond 270 days) for this permanent implant are unknown at present.