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Hawkone Directional Atherectomy System
Product: HawkOne — all models and sizes
Summary: The HawkOne Directional Atherectomy System, manufactured by Covidien, is used for atherectomy procedures. Key evidence shows successful lysis of venous valves with significant flow improvement and no major complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K141801 ↗
Decision Date ?
October 16, 2014
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The HawkOne Directional Atherectomy System received FDA clearance via the 510(k) pathway on October 16, 2014. It is manufactured by Covidien and classified as a Class 2 device under product code MCW.
What It Is
The HawkOne Directional Atherectomy System is a medical device designed for the removal of atherosclerotic plaque from blood vessels. It is primarily used in peripheral artery disease to improve blood flow by excising plaque from the vessel walls.
FDA-Cleared Indications
- Atherectomy in peripheral arteries affected by atherosclerotic disease.
- Removal of plaque from peripheral vascular lesions to improve blood flow.
- Use in peripheral vessels within the device's labeled size and anatomical ranges.
Clinical Applications
- Directional atherectomy of femoropopliteal artery lesions.
- Plaque removal during endovascular treatment of peripheral artery disease.
- Lesion preparation before or during balloon angioplasty or other peripheral interventions.
- Treatment of symptomatic peripheral arterial stenosis when plaque removal is clinically appropriate.
Evidence Summary
The available literature includes a case series study and two clinical trials, with the case series published in 2024. The studies focus on the device's efficacy in treating vascular lesions, though detailed outcomes from the trials are not provided.
Reported Outcomes
Published studies report successful lysis of retained venous valves using the HawkOne system, with significant improvement in blood flow. The case series highlights the device's effectiveness in addressing high-grade bypass graft stenosis.
Safety Profile
Reported complications include no major adverse events in the case series study. The safety profile appears favorable, with no significant complications noted in the available evidence.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes from the clinical trials. Further research is needed to establish long-term efficacy and safety across diverse patient populations.
Practical Considerations
- The system is available in catheter configurations and sizes intended for specific peripheral vessel diameters; the operator must select the size specified in the current instructions for use.
- It is delivered through a vascular access sheath or guide catheter under fluoroscopic imaging, usually through femoral or other peripheral arterial access.
- The device is intended to remove excised plaque into its collection system; repeated passes may be required, and excessive manipulation can increase the risk of dissection, perforation or distal embolization.
- MRI safety depends on the specific system components and whether the device remains in the patient. The current manufacturer labeling should be checked before MRI; an atherectomy catheter is generally removed after the procedure.
- Important risks include bleeding at the access site, arterial dissection or perforation, thrombosis, distal embolization, infection, contrast reaction and kidney injury. Antiplatelet or anticoagulant treatment may be used according to the overall procedure and patient factors.
Frequently Asked Questions
What are the clinical indications for HawkOne Directional Atherectomy System?
The device is indicated for the removal of atherosclerotic plaque in peripheral artery disease, particularly in femoropopliteal artery lesions.
What outcomes have been reported in clinical studies?
Studies report successful plaque removal with significant improvement in blood flow and no major complications.
What complications have been reported?
Safety data from the case series indicates no major complications associated with the use of the HawkOne system.
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.