Taxus EXPRESS2 Monorail and Over-The-Wire Coronary Stent Systems

FDA-Cleared Indications

• FDA approval under PMA P030025 included manufacturing-process changes for the TAXUS Express2 coronary stent systems.
• The approved changes added an in-process inspection, modified an existing in-process inspection, and modified manufacturing processes.
• These changes addressed complaints involving failure of the delivery-system balloon to properly deflate after stent deployment.

Clinical Applications

• Deployment of a drug-eluting stent in a coronary artery during percutaneous coronary intervention, when use is consistent with the device labeling.
• Treatment of appropriately selected coronary artery stenoses using the TAXUS Express2 Monorail or Over-the-Wire delivery configuration.
• Coronary stent placement in a hospital cardiac catheterization laboratory by trained interventional cardiology personnel.

Reported off-label uses

• Use of coronary drug-eluting stents in selected noncoronary peripheral vessels has been reported in clinical practice, but this is outside the device's coronary labeling and should not be assumed to be safe or effective.
• Use in other vascular beds or lesion types outside the approved labeling may occur in specialized circumstances, but requires independent clinical judgment and review of current evidence.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The system is available in Monorail and Over-the-Wire configurations; the appropriate platform depends on guidewire access, lesion anatomy, and operator preference.
• Available stent diameters and lengths vary by model and must match the target coronary vessel and lesion dimensions according to the current product labeling.
• The system is advanced and deployed over a guidewire under fluoroscopic imaging, typically through radial or femoral arterial access.
• Careful balloon inflation and deflation technique is required. The FDA record specifically describes manufacturing changes intended to address balloon-deflation complaints.
• MRI eligibility depends on the exact implanted stent, its configuration, and the conditions in the applicable labeling. The device should not be considered automatically MRI safe; confirm the current MR conditions before scanning.