Products

Stentplus™ Patient Success Program

TAXUS® Express²® Coronary Stent System

The ability to reduce restenosis, treat a variety of lesions and achieve safe, predictable outcomes for patients.

PRESCRIPTIVE INFORMATION

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

Indications

The TAXUS Express² Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions ≤ 28mm in length in native coronary arteries ≥ 2.5 to ≤ 3.75mm in diameter.

Contradictions

Use of the TAXUS Express² Paclitaxel-Eluting Coronary Stent System is contraindicated in patients with:

Known hypersensitivity to paclitaxel or structurally related compounds.
Known hypersensitivity to the polymer or its individual components.

Coronary Artery Stenting is contraindicated for use in:

Patients who cannot receive recommended anti-platelet therapy and/or anticoagulant therapy.
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.

Warnings

To maintain sterility, the inner package should not be opened or damaged prior to use.
The use of this product carries the risks associated with coronary artery stenting, including subacute thrombosis, vascular complications, and/or bleeding events.
Patients with known hypersensitivity to 316L stainless steel may suffer an allergic reaction to this implant.
This product should not be used in patients who are 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. Data from TAXUS Stent 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 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. Additional data from longer-term follow-up in the randomized clinical trials on the TAXUS Stent and analyses of DES-related stent thrombosis are expected and should be considered in making treatment decisions as data become available.

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 drug-eluting 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 (in alphabetical order) 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.

The safety and effectiveness of the TAXUS Express² Paclitaxel-Eluting Coronary Stent System have not been established in the cerebral, carotid, or peripheral vasculature or the following patient populations:

Patients with vessel thrombus at the lesion site.
Patients with coronary artery reference vessel diameters < 2.5mm or > 3.75mm.
Patients with coronary artery lesions longer than 28mm or requiring more than one TAXUS Stent.
Patients with lesions located in the saphenous vein grafts, in the unprotected left main coronary artery, ostial lesions, or lesions located at a bifurcation.
Patients with diffuse disease or poor flow distal to the identified lesions.
Patients with tortuous vessels (>60 degrees) in the region of the obstruction or proximal to the lesion.
Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
Patients with in-stent restenosis.
Patients with moderate or severe calcification in the lesion or a chronic total occlusion.
Patients with multi-vessel disease.