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clearlumen ii peripheral thrombectomy system
Walk Vascular
Summary: The ClearLumen II Peripheral Thrombectomy System is a medical device used to remove thrombi from peripheral arteries. It is primarily used by interventional radiologists and vascular surgeons to treat patients with arterial occlusions.
FDA Clearance Information
Pathway
510K
Number
K163051 ↗
Decision Date
February 21, 2017
Product Code
QEZ
Device Class
Class 2
Evidence
0 studies
The ClearLumen II Peripheral Thrombectomy System was cleared through the FDA 510(k) pathway on February 21, 2017. It is manufactured by Walk Vascular and is classified as a Class 2 medical device.
What It Is
The ClearLumen II Peripheral Thrombectomy System is a mechanical thrombectomy device designed to remove blood clots from peripheral arteries. It operates by using a catheter-based system that can navigate through the vascular system to reach and extract thrombotic material. This device is particularly useful in restoring blood flow in cases of acute or subacute thrombotic occlusions.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to treat patients with peripheral arterial occlusions, particularly in the femoropopliteal region. It is suitable for patients with acute or subacute thrombotic events where rapid restoration of blood flow is critical. The system is used in hospital settings, often in catheterization labs or operating rooms.
Indications for Use
The ClearLumen II is indicated for use in patients with peripheral arterial thrombotic occlusions. It is designed to remove blood clots from arteries in the legs, particularly in cases where other treatments have been ineffective or are not suitable.
Practical Considerations
The device is typically available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in peripheral interventions. Clinicians should be trained in endovascular techniques to ensure effective and safe use of the system.
Related Literature
The linked study, conducted in Belgium, evaluated the efficacy of the ClearLumen II system in recanalizing acute and subacute thrombotic occlusions in the femoropopliteal arteries. Although the abstract is not available, the study likely focused on the device's ability to restore blood flow and its safety profile. Limitations may include a small sample size or lack of long-term follow-up data.
Frequently Asked Questions
What is the ClearLumen II Peripheral Thrombectomy System used for?
It is used to remove thrombi from peripheral arteries, particularly in cases of acute or subacute occlusions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for removing thrombi from peripheral arteries, especially in the femoropopliteal region.
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.