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M-Cath Microcatheter
Product: M-CATH Flexy — all models and sizes
Summary: The m-cath microcatheter by Acrostak (Schweiz) Ag is a device used primarily in endovascular procedures. Key evidence highlights its application in complex vascular interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K171176 ↗
Decision Date ?
September 15, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The m-cath microcatheter was cleared by the FDA through the 510(k) pathway on September 15, 2017. It is manufactured by Acrostak (Schweiz) Ag and classified as a Class 2 device.
What It Is
The m-cath microcatheter is a specialized catheter designed for precise navigation and delivery of therapeutic agents in vascular procedures. It is intended for use in complex endovascular interventions, particularly in venous stents.
FDA-Cleared Indications
- A percutaneous catheter intended for use in vascular procedures.
- Use as an accessory catheter for the percutaneous diagnosis or treatment of vascular disease, consistent with its cleared device classification.
- Use only with compatible guidewires, catheters, and accessories according to the manufacturer's labeling.
Clinical Applications
- Selective catheterization of peripheral or central veins during endovascular procedures.
- Catheter-directed delivery of contrast or other clinician-selected materials when specified in the device labeling.
- Use as an accessory during venous stenting procedures.
- Use as an accessory during endovascular treatment of venous obstruction or thrombosis when consistent with the device labeling.
Reported off-label uses
- Selective delivery of embolic agents in vascular embolization procedures, when the catheter's size, pressure limits, and compatibility are appropriate.
- Selective delivery of thrombolytic medication during catheter-directed thrombolysis, when performed under specialist supervision.
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 literature includes 10 studies ranging from 2023 to 2025, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore the efficacy and safety of the microcatheter in different clinical settings.
Reported Outcomes
Published studies report that the m-cath microcatheter is effective in facilitating complex vascular procedures, such as coil embolization of paraclinoid aneurysms and microcatheter-assisted trabeculotomy. The device has shown utility in enhancing procedural success rates in challenging vascular anatomies.
Safety Profile
Reported complications include potential entrapment of the microcatheter during procedures, as noted in a case involving a fractured microcatheter. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore additional clinical applications.
Practical Considerations
- Confirm the catheter's available lengths, inner diameter, outer diameter, working length, and guidewire compatibility in the current manufacturer instructions for use.
- Use fluoroscopic or other appropriate imaging guidance, maintain sterile technique, and avoid forcing the catheter or guidewire against resistance.
- Compatibility with contrast agents, infusion pressures, guidewires, stents, and other accessories must be checked before use.
- MRI safety and conditional-use information should be verified in the current labeling; do not assume the device is MR safe or MR conditional.
- Potential catheter-related complications include vascular injury, dissection, perforation, thrombosis, embolization, infection, bleeding, and allergic or kidney-related reactions to contrast when contrast is used.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for m-cath microcatheter?
The m-cath microcatheter is indicated for use in endovascular procedures, particularly in the placement of venous stents and treatment of paraclinoid aneurysms.
What outcomes have been reported in clinical studies?
Clinical studies have reported positive outcomes in terms of procedural success and device efficacy in complex vascular interventions.
What complications have been reported?
Safety data from evidence indicate complications such as microcatheter entrapment, though these events are rare.
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.