Products

Stentplus™ Patient Success Program

TAXUS® Liberté® Atom™
Paclitaxel-eluting Coronary Stent System

Designed for Drug Delivery in Small Vessels

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 Liberté 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 Liberté 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 cannot receive recommended antiplatelet 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 allcause 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 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 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 Characteristics

The safety and effectiveness of the TAXUS Liberté Paclitaxel-Eluting Coronary Stent System have 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 with in-stent restenosis; lesions where there is evidence of thrombus or poor flow; pediatric patients.