📊 Evidence-Based Reference
Taxus Liberte Paclitaxel-Eluting Coronary Stent System
Summary: The Taxus Liberté Paclitaxel-Eluting Coronary Stent System is used to improve luminal diameter in coronary arteries. It is FDA-cleared for treating de novo lesions. Key evidence includes multiple studies assessing its efficacy and safety.
FDA Clearance Information
Pathway ?
PMA
Number ?
P060008 ↗
Decision Date ?
July 13, 2009
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The Taxus Liberté stent received FDA premarket approval (PMA) on July 13, 2009. Manufactured by Boston Scientific, it is classified as a Class III device.
What It Is
The Taxus Liberté Paclitaxel-Eluting Coronary Stent System is a drug-eluting stent designed to release paclitaxel to prevent restenosis. It is intended for use in native coronary arteries to treat de novo lesions.
FDA-Cleared Indications
- Treatment of de novo lesions in native coronary arteries measuring 2.75 to 4.00 mm in diameter.
- Treatment of lesions up to 34 mm in length.
- The FDA approval described here adds a 38 mm TAXUS Liberté stent size, marketed as the TAXUS Liberté Long system with Monorail and over-the-wire delivery systems.
Clinical Applications
- Percutaneous coronary intervention for selected new coronary artery lesions.
- Placement in a native coronary artery to improve luminal diameter.
- Drug-eluting stent treatment of lesions in coronary arteries measuring 2.75 to 4.00 mm.
- Treatment of coronary lesions up to 34 mm in length using the approved stent and delivery-system configuration.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials and prospective registries, conducted between 2011 and 2016. These studies evaluate the stent's efficacy and safety in various patient populations.
Reported Outcomes
Published studies report that the Taxus Liberté stent effectively reduces restenosis rates and improves luminal diameter in treated arteries. Long-term follow-up studies, such as the TAXUS ATLAS trials, demonstrate sustained efficacy over five years.
Safety Profile
Reported complications include stent thrombosis and restenosis, though these are relatively rare. Some studies highlight the need for careful patient selection to minimize adverse events.
Evidence Limitations
Evidence gaps include limited data on long-term outcomes beyond five years and specific subpopulations, such as diabetic patients. Further research is needed to explore these areas and optimize patient outcomes.
Practical Considerations
- The FDA indication specifies native coronary arteries 2.75 to 4.00 mm in diameter and lesions no longer than 34 mm; the 38 mm product refers to stent length and does not expand the labeled lesion-length limit.
- The system is available with Monorail and over-the-wire delivery systems. The treating cardiologist selects the delivery configuration and stent dimensions based on angiography and vessel measurements.
- Drug-eluting stents generally require antiplatelet therapy after implantation; the duration and regimen depend on the clinical situation and current cardiology guidance.
- Patients with a coronary stent need follow-up for recurrent symptoms, restenosis, thrombosis and medication-related issues. Device-specific contraindications, warnings and MRI conditions should be checked in the current labeling and implant documentation.
- This is a coronary interventional cardiology device, not a device for peripheral, dialysis-access, venous or neurovascular thrombectomy procedures.
Frequently Asked Questions
What are the clinical indications for Taxus Liberté stent?
The stent is indicated for improving luminal diameter in de novo lesions in native coronary arteries with diameters between 2.75 mm and 4.00 mm.
What outcomes have been reported in clinical studies?
Studies report reduced restenosis rates and improved luminal diameter, with sustained efficacy observed in long-term follow-ups.
What complications have been reported?
Reported complications include stent thrombosis and restenosis, though these events are relatively rare.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.