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wedge microcatheter
Microvention
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 510K
Number K172014 ↗
Decision Date April 5, 2018
Product Code DQY
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.
Clinical Applications
This device is commonly used in neurointerventional procedures, especially in the context of acute ischemic stroke where rapid and effective thrombus removal is essential. Interventional radiologists and neurointerventionalists employ the wedge microcatheter to navigate difficult vascular pathways, improving the success rate of aspiration thrombectomy. It is used in hospital settings, particularly in stroke centers and specialized vascular intervention units.
Indications for Use
The wedge microcatheter is indicated for use in patients requiring endovascular access to remove thrombi, particularly in cases of acute ischemic stroke. It is designed to assist in navigating challenging vascular anatomy to reach the target site more effectively.
Practical Considerations
The wedge microcatheter is typically compatible with larger aspiration catheters like the SofiaPlus 6F. Clinicians should consider the specific vascular anatomy of the patient when selecting catheter size and approach. Familiarity with catheter navigation techniques is essential for optimal 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.
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.