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multicross catheter
Roxwood Medical
Summary: The multicross catheter by Roxwood Medical is a multi-lumen device primarily used for chronic total occlusions. Key evidence includes initial animal and human studies demonstrating its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K152957 ↗
Decision Date
March 4, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The multicross catheter was cleared through the FDA 510(k) pathway on March 4, 2016. It is manufactured by Roxwood Medical and classified as a Class 2 device under product code DQY.
What It Is
The multicross catheter is a multi-lumen device designed for use in chronic total occlusions. It facilitates the crossing of occluded vessels, aiding in the delivery of therapeutic agents or devices.
Clinical Applications
Commonly used in interventional cardiology, the multicross catheter is employed in scenarios involving chronic total occlusions, particularly in coronary and peripheral arteries.
Evidence Summary
The available literature includes a preclinical and first-in-man study published in 2016, and an ongoing registry study. These studies explore the device's performance and safety in occluded vessels.
Reported Outcomes
Published studies report that the multicross catheter is effective in facilitating the crossing of chronic total occlusions. Initial results from animal and human trials indicate promising efficacy in both preclinical and clinical settings.
Safety Profile
Reported complications include typical procedural risks associated with catheter use, but specific adverse events were not detailed in the provided studies. Further safety data is anticipated from ongoing research.
Evidence Limitations
Current evidence is limited to initial studies with small sample sizes. There is a need for larger, randomized controlled trials to better understand long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for multicross catheter?
The multicross catheter is indicated for use in chronic total occlusions, particularly in coronary and peripheral arteries.
What outcomes have been reported in clinical studies?
Studies have reported that the multicross catheter is effective in crossing occluded vessels, with initial trials showing promising results.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events were not detailed in the available studies.
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.