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clearlumen ii peripheral thrombectomy system
Walk Vascular
Summary: The ClearLumen II Peripheral Thrombectomy System is a medical device used for the removal of thrombi in peripheral arteries. It is primarily used by interventional radiologists and vascular surgeons to treat patients with arterial occlusions.
FDA Clearance Information
Pathway
510K
Number
K172000 ↗
Decision Date
October 24, 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 October 24, 2017. It is manufactured by Walk Vascular and classified as a Class 2 device under product code QEZ.
What It Is
The ClearLumen II Peripheral Thrombectomy System is a mechanical device designed to remove thrombi from peripheral arteries. It operates by using a catheter-based approach to aspirate and extract blood clots, thereby restoring blood flow. This device is particularly useful in treating patients with acute or subacute thrombotic occlusions in the femoropopliteal region.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to treat patients with peripheral arterial disease, particularly those with thrombotic occlusions in the femoropopliteal arteries. It is suitable for use in hospitals and specialized vascular centers, where quick restoration of blood flow is critical. Patients who benefit from this device typically present with symptoms of acute limb ischemia or claudication.
Indications for Use
The FDA indications for the ClearLumen II include the removal of thrombi in peripheral arteries, specifically targeting acute or subacute thrombotic occlusions. It is intended for patients experiencing compromised blood flow due to clot formation in the femoropopliteal region.
Practical Considerations
The ClearLumen II system is compatible with standard catheterization techniques and is available in various sizes to accommodate different vessel diameters. Clinicians should be familiar with catheter-based thrombectomy procedures and ensure compatibility with existing vascular access equipment.
Related Literature
The linked Belgian trial evaluated the effectiveness of the ClearLumen II in recanalizing acute and subacute thrombotic occlusions in the femoropopliteal arteries. While specific results and limitations are not detailed, the study likely focused on clinical outcomes such as recanalization rates and procedural safety. The absence of an abstract limits the ability to assess detailed findings.
Frequently Asked Questions
What is the ClearLumen II Peripheral Thrombectomy System used for?
It is used for the removal of thrombi in peripheral arteries, particularly in the femoropopliteal region.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi in peripheral arteries, focusing on acute or subacute thrombotic occlusions.
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.