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microcross catheter
Roxwood Medical
Summary: The microcross catheter is a medical device used primarily in interventional cardiology for navigating through stenotic lesions or chronic total occlusions in arteries. It is typically used by interventional cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K151082 ↗
Decision Date
June 7, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The microcross catheter was cleared through the FDA 510(k) pathway on June 7, 2015. Manufactured by Roxwood Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The microcross catheter is a specialized catheter designed to facilitate the crossing of stenotic lesions or chronic total occlusions in blood vessels. It is equipped with features that enhance its ability to navigate through complex vascular anatomy, making it a valuable tool in interventional cardiology. Its design allows for precise delivery and support of guidewires or other interventional devices.
Clinical Applications
The microcross catheter is commonly used in procedures involving the treatment of coronary artery disease, particularly in cases with challenging stenotic lesions or chronic total occlusions. It is utilized in catheterization labs by interventional cardiologists to improve access and facilitate the delivery of therapeutic devices such as stents. The device is particularly beneficial in patients with complex coronary anatomy or those undergoing percutaneous coronary interventions.
Indications for Use
The FDA indications for the microcross catheter involve its use in patients with narrowed or blocked arteries, specifically for navigating through difficult-to-treat lesions. This includes patients with chronic total occlusions, where the catheter assists in crossing the blockage to enable further treatment.
Practical Considerations
The microcross catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and interventional tools. Clinicians should be familiar with its handling characteristics and ensure proper technique to maximize its effectiveness and minimize complications.
Related Literature
The linked study is a registry evaluating the performance and safety of Roxwood Medical catheters, including the microcross, in patients with stenotic lesions or chronic total occlusions. Although specific results and limitations are not available, such studies typically assess procedural success rates, safety profiles, and long-term outcomes. This study likely provides insights into the catheter's effectiveness in real-world clinical settings.
Frequently Asked Questions
What is the microcross catheter used for?
The microcross catheter is used to navigate through stenotic lesions or chronic total occlusions in arteries, aiding in interventional procedures.
What specialties typically use this device?
Interventional cardiologists primarily use the microcross catheter in catheterization labs during coronary interventions.
What are the FDA-cleared indications?
The microcross catheter is indicated for use in patients with narrowed or blocked arteries, specifically for crossing difficult lesions or 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.