đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Removal of thrombi from peripheral arteries.
- Treatment of peripheral arterial thrombotic occlusions.
Clinical Applications
- Mechanical removal of thrombus from peripheral leg arteries.
- Endovascular treatment of acute or subacute peripheral arterial occlusions when clot removal is indicated.
- Use during catheter-based peripheral vascular interventions performed in an interventional radiology or vascular surgery setting.
Practical Considerations
- The system is intended for use by clinicians trained in endovascular and peripheral vascular techniques.
- The appropriate device size should be selected for the target vessel and clot burden; available sizes and compatible equipment should be confirmed in the current manufacturer instructions for use.
- The system is used with fluoroscopic or other appropriate intravascular imaging guidance through vascular access, commonly in the groin or another suitable peripheral artery.
- MRI safety depends on the specific device components and labeling. Confirm the current manufacturer MRI conditions before scanning a patient who has retained or implanted components.
- Contraindications, access-site risks, vessel injury, bleeding, distal embolization and incomplete clot removal should be reviewed in the current FDA-cleared labeling and instructions for use.
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.