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taxus express2 monorail and over-the-wire coronary stent systems
Boston Scientific
Summary: The Taxus Express2 is a coronary stent system used to treat coronary artery disease. It is primarily used by interventional cardiologists during percutaneous coronary interventions.
FDA Clearance Information
Pathway
PMA
Number
P030025 ↗
Decision Date
May 5, 2004
Product Code
NIQ
Device Class
Class 3
Evidence
0 studies
The Taxus Express2 stent systems, manufactured by Boston Scientific, received FDA clearance under PMA P030025 on May 5, 2004. It is a Class III medical device.
What It Is
The Taxus Express2 is a drug-eluting coronary stent system designed to open narrowed or blocked coronary arteries. It releases a drug to prevent restenosis, or re-narrowing, of the artery. The system is available in both monorail and over-the-wire configurations, allowing flexibility in different procedural settings.
Clinical Applications
This device is commonly used in interventional cardiology for patients with coronary artery disease, particularly those at risk of restenosis. It is deployed during percutaneous coronary interventions in catheterization labs, primarily in hospital settings. The stent is suitable for patients with complex lesions and those undergoing repeat interventions.
Indications for Use
The FDA indications include improvements in the manufacturing process to ensure the delivery system balloon deflates properly after stent deployment. This is critical for patients requiring precise stent placement and reliable device performance.
Practical Considerations
The Taxus Express2 stent systems come in various sizes to accommodate different vessel diameters and lesion lengths. They are compatible with standard catheterization lab equipment. Proper technique in balloon inflation and deflation is essential to ensure optimal stent deployment.
Frequently Asked Questions
What is the Taxus Express2 used for?
It is used to treat coronary artery disease by keeping arteries open and reducing the risk of restenosis.
What specialties typically use this device?
Interventional cardiologists typically use this device during percutaneous coronary interventions.
What are the FDA-cleared indications?
The indications include enhancements in manufacturing processes to improve balloon deflation reliability post-deployment.
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.