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m-cath microcatheter
Acrostak (Schweiz) Ag
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
510K
Number
K171176 ↗
Decision Date
September 15, 2017
Product Code
DQY
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.
Clinical Applications
Commonly used in procedures involving venous stents, the m-cath microcatheter is employed in scenarios requiring high precision and control, such as in the treatment of paraclinoid aneurysms and chronic total occlusions.
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.
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.