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Hawkone Directional Atherectomy System
Medtronic Vascular
Product: HawkOne — all models and sizes
Summary: The HawkOne Directional Atherectomy System by Medtronic is used for atherectomy procedures, primarily in peripheral artery disease. Key evidence includes successful lysis of venous valves with significant flow improvement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K161361 ↗
Decision Date ?
October 14, 2016
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The HawkOne Directional Atherectomy System received FDA clearance through the 510(k) pathway on October 14, 2016. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The HawkOne Directional Atherectomy System is a medical device designed for the removal of atherosclerotic plaque from peripheral arteries. It is intended for use in atherectomy procedures to improve blood flow in patients with peripheral artery disease.
FDA-Cleared Indications
- For directional atherectomy of peripheral arteries in patients with peripheral arterial disease.
- For removal of atherosclerotic plaque to help restore or improve blood flow in treated peripheral vessels.
- Intended for use in peripheral vessels within the device's labeled size and anatomical limits.
Clinical Applications
- Removing plaque from diseased peripheral arteries during an endovascular atherectomy procedure.
- Treating atherosclerotic disease in the femoropopliteal circulation when plaque removal is clinically appropriate.
- Reducing plaque burden before or instead of adjunctive balloon angioplasty, stenting, or other treatment, when consistent with the device labeling.
- Improving blood flow in patients with symptomatic peripheral arterial disease caused by removable plaque.
Evidence Summary
The available literature includes a case series and two clinical trials, focusing on the use of directional atherectomy in peripheral artery disease. The studies span from 2016 to 2024, providing insights into both efficacy and safety.
Reported Outcomes
Published studies report successful lysis of retained venous valves with significant improvement in blood flow. The case series demonstrated effective plaque removal in a femoropopliteal bypass graft, achieving the desired clinical outcomes without major complications.
Safety Profile
Reported complications include no major adverse events in the case series. The safety profile appears favorable, with no significant issues noted in the available evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and compare efficacy with other atherectomy devices.
Practical Considerations
- The system is used over an appropriately sized guidewire through vascular access, commonly from the common femoral artery, with fluoroscopic guidance.
- Device size, vessel diameter, lesion length, and access requirements must match the manufacturer's instructions for use; the specific HawkOne catheter configuration should be confirmed before treatment.
- Atherectomy may be followed by balloon angioplasty, drug-coated balloon treatment, stenting, or other therapy when clinically indicated.
- Potential complications include bleeding or hematoma at the access site, vessel injury, dissection, perforation, distal embolization, thrombosis, restenosis, infection, and contrast-related complications.
- MRI safety depends on the specific device components and whether the system remains implanted; the catheter is generally removed after the procedure. Follow the current manufacturer's MRI labeling and instructions for use.
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 arteries, particularly in patients with peripheral artery disease.
What outcomes have been reported in clinical studies?
Studies have reported successful plaque removal and significant improvement in blood flow, with no major complications.
What complications have been reported?
The available evidence indicates no major complications were reported in the case series involving 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.