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hawkone directional atherectomy system
Covidien
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
510K
Number
K141801 ↗
Decision Date
October 16, 2014
Product Code
MCW
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.
Clinical Applications
Commonly used in the treatment of peripheral artery disease, the HawkOne system is applied in scenarios where plaque removal is necessary to restore adequate blood flow, such as in femoropopliteal artery lesions.
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.
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.