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hawkone directional atherectomy system
Medtronic Vascular
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
510K
Number
K161361 ↗
Decision Date
October 14, 2016
Product Code
MCW
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.
Clinical Applications
Commonly used in the treatment of peripheral artery disease, the HawkOne system is applied in scenarios such as removing plaque from femoropopliteal arteries to restore adequate blood flow and alleviate symptoms of critical limb ischemia.
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.
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.