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TAXUS® Express²® Atom™ Paclitaxel-Eluting Coronary Stent System
PRESCRIPTIVE INFORMATION
Indications
The TAXUS Express² Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries ≥ 2.25 to ≤ 4.0mm in diameter in lesions ≤ 28mm in length.
Contraindications
Use of the TAXUS Express² Paclitaxel-Eluting Coronary Stent System is contraindicated in patients with known hypersensitivity to 316L Stainless Steel, to paclitaxel or structurally related compounds, or known hypersensitivity to the polymer or its individual components. Coronary Artery Stenting is contraindicated for use in patients who can not receive recommended anti-platelet therapy and/or anticoagulant therapy or patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
Warnings
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 not likely to comply with recommended antiplatelet therapy.
Precautions
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. In the TAXUS clinical trials analyzed to date, the differences in the incidence of stent thrombosis observed with the TAXUS Stent compared to bare-metal stents have not been associated with an increased risk of cardiac death, myocardial infarction, or all-cause mortality. When drug-eluting stents are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the pivotal clinical trials.
Compared to use within the specified Indications for Use, the use of drugeluting stents 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, or death.
Potential Adverse Effects
Potential adverse events which may be associated with the use of a coronary stent in native coronary arteries include but are not limited to: Aneurysm, Arrhythmias, Bleeding complications, Death, Distal Emboli, Emergent CABG, Myocardial Infarction, Myocardial Ischemia, Occlusion, Stent Delivery Failures, Target Lesion Revascularization, Thrombosis, Vascular complications, Vessel Dissection.
Potential adverse events not captured above that may be unique to the paclitaxel drug coating: Alopecia, Allergic reaction to the drug or the polymer, Anemia, Blood product transfusion, Gastrointestinal symptoms, Hematologic dyscrasia, Hepatic enzyme changes, Histologic changes in vessel wall, including inflammation, cellular damage or necrosis, Myalgia/Arthralgia, Peripheral neuropathy.
Precautions - Lesion/Vessel Characteristic
The safety and effectiveness of the TAXUS Express² Paclitaxel-Eluting Coronary Stent System has not been established in the cerebral, carotid, or peripheral vasculature or patients with:
- Vessel thrombus at the lesion site; coronary artery reference vessel diameters < 2.25mm or > 4.0mm; coronary artery lesions longer than 28mm or requiring more than one TAXUS stent; diffuse disease or poor flow distal to the identified lesions; tortuous vessels (>60 degrees) in the region of the obstruction or proximal to the lesion; a recent acute myocardial infarction; moderate or severe calcification in the lesion or a chronic total occlusion; multi-vessel disease; lesions located in saphenous vein grafts, in an unprotected left main coronary artery, ostial lesions, or lesions located at a bifurcation; lesions where there is evidence of thrombus or poor flow; pediatric patients; lesions with in-stent restenosis (TAXUS Express 2.25mm diameter stents).
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
