đź“‹ FDA Reference
Wedge Microcatheter
Product: Wedge — all models and sizes
Summary: The wedge microcatheter is a specialized device used in endovascular procedures to improve access to target vessels, particularly in challenging anatomical scenarios. It is primarily used by interventional radiologists and neurointerventionalists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172014 ↗
Decision Date ?
April 5, 2018
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The wedge microcatheter by Microvention was cleared via the FDA 510k pathway on April 5, 2018. It is a Class 2 medical device under product code DQY.
What It Is
The wedge microcatheter is a medical device designed to facilitate endovascular access in procedures such as thrombectomy. It works by reducing the gap between the microcatheter and larger catheters, like the SofiaPlus 6F, allowing for smoother navigation through complex vascular anatomy. This is particularly useful in neurovascular interventions where precise catheter positioning is critical.
FDA-Cleared Indications
- For percutaneous intravascular use to facilitate access to and navigation within blood vessels.
- For use with compatible catheter systems during endovascular procedures.
- Use is limited to the indications, anatomy, catheter combinations, and instructions described in the manufacturer’s labeling.
Clinical Applications
- Obtaining or improving percutaneous endovascular access in difficult vascular anatomy.
- Navigating to a selected target vessel during catheter-based intervention.
- Use as an accessory catheter with a compatible larger catheter system when specified by the manufacturer.
Reported off-label uses
- Use as an adjunct during aspiration thrombectomy for acute ischemic stroke has been described in clinical practice, but this application should not be assumed to be FDA-cleared without confirming the current device labeling.
- Use in other complex neurovascular or peripheral vascular access techniques may occur at specialist discretion, but these applications may be off-label.
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.
Practical Considerations
- Confirm the catheter’s inner diameter, outer diameter, working length, guidewire requirements, and compatibility with the planned guide or aspiration catheter before use.
- The device is intended for use by trained clinicians under fluoroscopic or other appropriate intravascular imaging guidance.
- Advance and withdraw the catheter gently; resistance, excessive force, or vessel tortuosity can increase the risk of spasm, dissection, perforation, or device damage.
- MRI safety depends on the exact model and whether the device remains in the patient. Review the manufacturer’s current labeling before MRI.
- Do not use if the device package is damaged, expired, or otherwise compromised. Contraindications, warnings, and anticoagulation requirements should be checked in the instructions for use.
Related Literature
The linked study explored the use of the wedge microcatheter in improving endovascular access for thrombus aspiration in acute stroke patients. It found that the device helped overcome anatomical challenges, facilitating better catheter positioning. However, the study was limited by its initial experience scope and did not include a large patient population, suggesting the need for further research to validate these findings.
Procedures that use this device
Frequently Asked Questions
What is the wedge microcatheter used for?
The wedge microcatheter is used to improve access to target vessels in endovascular procedures, particularly for thrombus aspiration in acute ischemic stroke.
What specialties typically use this device?
Interventional radiologists and neurointerventionalists typically use the wedge microcatheter in procedures requiring precise vascular access.
What are the FDA-cleared indications?
The device is indicated for use in facilitating endovascular access for thrombus removal in patients with challenging vascular anatomy, such as those with acute ischemic stroke.
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.