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microcatheter
Surmodics
Summary: The microcatheter by Surmodics is a device used in minimally invasive procedures, primarily for venous stenting. Key evidence highlights its role in reducing intraocular pressure in glaucoma and its application in venous sinus manometry.
FDA Clearance Information
Pathway 510K
Number K173560 ↗
Decision Date January 12, 2018
Product Code DQY
Device Class Class 2
Evidence 0 studies
The microcatheter by Surmodics received FDA clearance through the 510(k) pathway on January 12, 2018. It is classified as a Class 2 device under product code DQY.
What It Is
The microcatheter is a small, flexible tube designed for use in minimally invasive procedures. It is intended for navigating complex vascular pathways and delivering therapeutic agents or devices in clinical settings.
Clinical Applications
Commonly used in procedures such as venous stenting and minimally invasive glaucoma surgery, the microcatheter assists in precise delivery and measurement tasks within the vascular system.
Evidence Summary
The literature includes 15 studies, encompassing randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from 2023 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that microcatheter-assisted procedures can effectively reduce intraocular pressure in glaucoma patients over time points of 3 months to 1 year. Additionally, the device is used for venous sinus manometry in idiopathic intracranial hypertension, although specific outcomes are not detailed.
Safety Profile
Reported complications include hyphema, intraocular pressure spikes, and hypotony in glaucoma procedures. These adverse events highlight the need for careful monitoring during and after microcatheter-assisted interventions.
Evidence Limitations
The evidence is limited by the lack of head-to-head trials comparing microcatheter-assisted procedures with other standard treatments. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for microcatheter?
The microcatheter is indicated for use in venous stenting and minimally invasive glaucoma surgery, among other vascular procedures.
What outcomes have been reported in clinical studies?
Studies have reported effective intraocular pressure reduction in glaucoma patients and its use in venous sinus manometry, though specific outcomes vary.
What complications have been reported?
Safety data indicates complications such as hyphema, intraocular pressure spikes, and hypotony in certain procedures.
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.