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lumend percutaneous catheter
Lumend
Summary: The Lumend percutaneous catheter is a medical device used for revascularization procedures, particularly in chronic total occlusions. It is primarily used by interventional cardiologists and vascular specialists.
FDA Clearance Information
Pathway
510K
Number
K011562 ↗
Decision Date
January 16, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Lumend percutaneous catheter was cleared via the FDA 510k pathway on January 16, 2002. Manufactured by Lumend, it is a Class 2 device under product code DQY.
What It Is
The Lumend percutaneous catheter is designed to assist in the revascularization of occluded vessels. It works by facilitating access to the true lumen of a vessel that is blocked by chronic total occlusions. This device is particularly useful in complex cases where traditional guidewires may fail to penetrate the occlusion.
Clinical Applications
This catheter is commonly used in interventional cardiology and vascular surgery settings, especially for patients with chronic total occlusions of coronary or peripheral arteries. It is typically employed in catheterization labs by specialists trained in percutaneous interventions. The device is suitable for patients with challenging occlusions that require advanced techniques for successful revascularization.
Indications for Use
The FDA indications suggest that the Lumend percutaneous catheter is intended for use in patients with blocked blood vessels, particularly those with chronic total occlusions. It is designed to help restore blood flow in these challenging cases.
Practical Considerations
The Lumend catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in percutaneous interventions. Clinicians should be familiar with microdissection techniques and prepared for potential complications such as vessel dissection.
Related Literature
The linked study describes a case of successful revascularization of a chronic total occlusion using the LuMend Frontrunner catheter. The procedure was complicated by a coronary artery dissection, but after 7 weeks, the true lumen became accessible, leading to procedural success. While the study highlights the catheter's effectiveness, it is limited by its single-case nature and the complexity of the procedure.
Frequently Asked Questions
What is the Lumend percutaneous catheter used for?
It is used for revascularizing occluded vessels, especially in chronic total occlusions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with blocked blood vessels, particularly for chronic total occlusions.
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.