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modification to lumend frontrunner cto catheter
Lumend
Summary: The Lumend Frontrunner CTO Catheter is a medical device used to facilitate the crossing of chronic total occlusions in coronary arteries. It is primarily used by interventional cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K023223 ↗
Decision Date
October 24, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 24, 2002, by Lumend. It is classified as a Class 2 device under product code DQY.
What It Is
The Lumend Frontrunner CTO Catheter is designed to assist in the treatment of chronic total occlusions (CTOs) in coronary arteries. It works by mechanically disrupting the occlusion, allowing for subsequent balloon angioplasty or stent placement. The device is typically used in percutaneous coronary intervention (PCI) procedures, providing a less invasive option compared to surgical intervention.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly in cases where patients have CTOs that are difficult to treat with standard guidewires. It is used in catheterization labs by cardiologists trained in PCI procedures. The device is suitable for adult patients with coronary artery disease, especially those who have not responded to medical therapy.
Indications for Use
The device is indicated for use in patients with chronic total occlusions in coronary arteries, where traditional guidewire techniques have failed. It is specifically designed to facilitate the crossing of these occlusions to enable further treatment.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters and lesion characteristics. It is compatible with standard PCI equipment and requires specific training for optimal use. Operators should be familiar with its mechanical operation and integration into existing procedural workflows.
Frequently Asked Questions
What is the modification to Lumend Frontrunner CTO Catheter used for?
It is used to facilitate the crossing of chronic total occlusions in coronary arteries during PCI procedures.
What specialties typically use this device?
Interventional cardiologists in catheterization labs primarily use this device.
What are the FDA-cleared indications?
It is indicated for patients with chronic total occlusions in coronary arteries where traditional guidewire techniques have failed.
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.