đź“Š Evidence-Based Reference
Microcatheter
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 ?
510(k)
Number ?
K232647 ↗
Decision Date ?
September 29, 2023
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For percutaneous catheter use in selected minimally invasive procedures, as described by the cleared device labeling.
- The FDA record lists the device under product code DQY, Catheter, Percutaneous, 21 CFR 870.1250.
Clinical Applications
- Percutaneous catheter-based access and navigation during selected vascular procedures.
- Use as an accessory catheter during procedures involving venous stent placement when compatible with the overall procedure and labeling.
- Navigation through small or difficult-to-reach vessels during minimally invasive interventions.
Reported off-label uses
- Selective delivery of embolic materials in vascular embolization procedures, when the specific device labeling does not include that use.
- Intracranial or spinal vascular navigation in neurointerventional procedures, when the specific device is not labeled for those vessels.
- Delivery of medications or other agents through small vessels when that application is not included in the device labeling.
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, 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.
Practical Considerations
- Confirm the catheter's usable length, outer diameter, inner diameter, and guidewire or sheath compatibility before the procedure.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for advancement, flushing, and contrast injection.
- Do not force the catheter if resistance is encountered; vessel injury, dissection, perforation, thrombosis, or catheter damage may occur.
- MRI safety depends on the exact model and labeling. Confirm MR Safe, MR Conditional, or MR Unsafe status before an MRI examination.
- Potential contraindications and precautions include unsuitable vascular anatomy, inability to obtain percutaneous access, active infection at the access site, contrast allergy, and bleeding or clotting disorders.
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 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.