đź“Š Evidence-Based Reference
Microcatheter
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 ?
510(k)
Number ?
K173560 ↗
Decision Date ?
January 12, 2018
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For percutaneous introduction into the vascular system during diagnostic or interventional procedures.
- For accessing selected blood vessels to facilitate the delivery of compatible diagnostic or therapeutic devices or agents.
- For use with compatible guidewires, catheters, and other accessories according to the device labeling.
Clinical Applications
- Percutaneous catheter-based access to peripheral or central veins.
- Navigation through complex vascular anatomy during venous interventions.
- Assistance with delivery of compatible devices or agents during an indicated vascular procedure.
- Catheter-based vascular pressure or flow measurements when included in the labeled procedure and system.
Reported off-label uses
- Selective catheterization of small intracranial vessels for neurointerventional procedures, when the specific device labeling does not include that use.
- Selective coronary or peripheral arterial catheterization, depending on catheter dimensions, pressure limits, compatibility, and institutional practice.
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 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.
Practical Considerations
- The microcatheter must be matched to the guidewire, introducer sheath, parent catheter, contrast agent, and other accessories used in the procedure.
- Available sizes, inner diameter, outer diameter, working length, and tip configuration vary by model; confirm the current product labeling before use.
- Use fluoroscopic or other appropriate imaging guidance, and follow the manufacturer's instructions for flushing, advancement, and removal.
- MRI safety depends on the exact model and whether the catheter is present, retained, or used with other implants; check the device-specific labeling rather than assuming it is MRI safe.
- Potential complications include vascular injury, bleeding, thrombosis, embolization, infection, vasospasm, perforation, and contrast-related reactions. Contraindications and warnings are model- and procedure-specific.
Procedures that use this device
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.