📋 FDA Reference
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 ?
510(k)
Number ?
K023223 ↗
Decision Date ?
October 24, 2002
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitation of crossing chronic total occlusions in coronary arteries during percutaneous coronary intervention.
- Use when conventional guidewire techniques have not successfully crossed the coronary occlusion.
Clinical Applications
- Crossing selected chronic total occlusions in coronary arteries.
- Facilitating subsequent balloon angioplasty after crossing the occlusion.
- Facilitating subsequent coronary stent placement after crossing the occlusion.
- Use in a cardiac catheterization laboratory by trained interventional cardiology clinicians.
Practical Considerations
- The device is intended for coronary use and should be selected according to the target vessel, occlusion characteristics and compatible PCI equipment.
- Use requires operators trained in chronic total occlusion crossing techniques and familiarity with the catheter's mechanical operation.
- The catheter is used with fluoroscopic imaging and standard percutaneous coronary intervention equipment.
- The record provided does not establish MRI safety or conditional labeling; MRI compatibility should be confirmed in the current FDA labeling and manufacturer instructions before scanning.
- As with other coronary crossing catheters, use requires assessment of risks such as vessel injury, perforation, dissection, bleeding and other complications of PCI.
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.