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microcatheter
Surmodics
Summary: The microcatheter by Surmodics is a device used primarily in venous stent procedures. Key evidence highlights its role in minimally invasive glaucoma surgery and fractional flow reserve measurements.
FDA Clearance Information
Pathway 510K
Number K232647 ↗
Decision Date September 29, 2023
Product Code DQY
Device Class Class 2
Evidence 0 studies
The microcatheter received FDA clearance through the 510(k) pathway on September 29, 2023. It is manufactured by Surmodics and classified as a Class 2 device.
What It Is
The microcatheter is a small, flexible catheter designed for use in minimally invasive procedures. It is intended for applications such as venous stenting and measuring fractional flow reserve in coronary interventions.
Clinical Applications
Commonly used in procedures requiring precise navigation through small vessels, the microcatheter is utilized in coronary interventions and glaucoma surgeries to improve procedural outcomes.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2023 and 2025.
Reported Outcomes
Published studies report that microcatheter-assisted procedures can effectively reduce intraocular pressure in glaucoma patients and aid in fractional flow reserve measurements during coronary interventions. However, specific quantitative outcomes were not detailed in the provided evidence.
Safety Profile
Reported complications include hyphema, intraocular pressure spikes, and hypotony in glaucoma surgeries. The safety profile in coronary applications remains under discussion.
Evidence Limitations
The evidence lacks head-to-head trials comparing microcatheter-assisted procedures with traditional methods. Further research is needed to establish long-term efficacy and safety across different clinical settings.
Frequently Asked Questions
What are the clinical indications for microcatheter?
The microcatheter is indicated for use in venous stenting and minimally invasive glaucoma surgeries.
What outcomes have been reported in clinical studies?
Studies report effective intraocular pressure reduction in glaucoma and utility in fractional flow reserve measurements.
What complications have been reported?
Safety data indicate potential complications such as hyphema, IOP spikes, and hypotony in glaucoma 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.