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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 ?
510(k)
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.
FDA-Cleared Indications
- Removal of thrombi from peripheral arteries.
- Treatment of acute or subacute thrombotic occlusions in peripheral arteries.
- Use in the femoropopliteal arterial region when clot removal is clinically indicated.
Clinical Applications
- Catheter-based thrombectomy for clot removal in peripheral arteries.
- Treatment of acute limb ischemia caused by a peripheral arterial thrombotic occlusion.
- Treatment of subacute thrombotic occlusions in the femoropopliteal arteries.
- Restoration of blood flow after thrombus removal from an occluded peripheral artery.
Practical Considerations
- The system is used through vascular access with fluoroscopic or other intravascular imaging guidance, according to the operator's technique and the device labeling.
- Available catheter sizes and vessel compatibility should be checked against the target artery diameter and the specific device configuration.
- Patients may require anticoagulation, thrombolytic medication, angioplasty, stenting, or open surgical treatment in addition to or instead of thrombectomy, depending on the cause and severity of the occlusion.
- The FDA record provided does not establish MRI safety or MR-conditional status; consult the current manufacturer labeling before MRI.
- Contraindications, warnings, and access-site requirements should be reviewed in the current instructions for use before treatment.
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.