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Reverse Medical Microcatheter
Summary: The reverse medical microcatheter is a device used primarily in venous stenting procedures. It is FDA 510k cleared and supported by 11 studies, focusing on its application in chronic total occlusion interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K130858 ↗
Decision Date ?
October 11, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The reverse medical microcatheter received FDA 510k clearance on October 11, 2013. It is manufactured by Reverse Medical and classified as a Class 2 device under product code DQY.
What It Is
The reverse medical microcatheter is a specialized catheter designed for use in venous stenting procedures. It facilitates the navigation and delivery of therapeutic agents or devices within the vascular system, particularly in challenging anatomical scenarios.
FDA-Cleared Indications
- Percutaneous use within the vascular system during image-guided procedures.
- Catheter-based access, navigation, or delivery in peripheral blood vessels, consistent with the FDA product code for percutaneous catheters.
Clinical Applications
- Image-guided catheter access during peripheral vascular interventions.
- Navigation through selected vascular anatomy to support delivery or exchange of interventional materials or devices.
Reported off-label uses
- Use as a support or access catheter during complex chronic total occlusion interventions, including selected retrograde approaches, when performed according to institutional practice and clinician judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as case reports and retrospective analyses, conducted between 2022 and 2024. These studies explore the device's application in complex vascular interventions.
Reported Outcomes
Published studies report that the reverse medical microcatheter significantly enhances the success rate of chronic total occlusion interventions, particularly when used in retrograde approaches. The device's design allows for improved navigation and delivery of therapeutic agents in complex vascular scenarios.
Safety Profile
Reported complications include challenges in wire externalization and crossing chronic total occlusions. However, specific adverse events directly attributed to the device were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and a focus on case reports and retrospective analyses. Further research is needed to establish comprehensive safety profiles and long-term outcomes.
Practical Considerations
- The available FDA summary does not specify catheter lengths, outer diameters, inner diameters, guidewire compatibility, or maximum injection pressure; these details should be confirmed in the current manufacturer instructions for use.
- Compatibility with guidewires, introducer sheaths, delivery systems, and contrast agents must be checked before the procedure.
- Use requires fluoroscopic or other appropriate image guidance and trained vascular-intervention personnel.
- MRI safety status is not established in the supplied record. Confirm whether the specific catheter is MR Safe, MR Conditional, or not evaluated before MRI.
- Potential catheter-procedure risks include vessel injury, bleeding, thrombosis, embolization, infection, contrast reaction, and vascular spasm; patient-specific contraindications should be assessed.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for reverse medical microcatheter?
The device is indicated for use in venous stenting procedures, particularly in chronic total occlusion interventions.
What outcomes have been reported in clinical studies?
Studies report improved success rates in chronic total occlusion procedures, especially with retrograde approaches.
What complications have been reported?
Reported complications include difficulties in wire externalization and crossing occlusions, though specific adverse events were not detailed.
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.