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freedomflow orbital circumferential atherectomy system h6005 4fr 3-sphere configuration
Cardio Flow Inc.,
Summary: The FreedomFlow Orbital Circumferential Atherectomy System is a medical device used for atherectomy procedures, primarily in treating calcified lesions. Key evidence includes its use in challenging cases such as heavily calcified saphenous vein grafts.
FDA Clearance Information
Pathway
510K
Number
K250723 ↗
Decision Date
April 25, 2025
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The FreedomFlow Orbital Circumferential Atherectomy System was cleared via the FDA 510(k) pathway on April 25, 2025. It is manufactured by Cardio Flow Inc. and classified as a Class 2 medical device.
What It Is
The FreedomFlow Orbital Circumferential Atherectomy System is designed to remove plaque from blood vessels, particularly in cases of severe calcification. It operates using an orbital mechanism to facilitate plaque debulking in peripheral and coronary arteries.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery to treat patients with peripheral artery disease and coronary artery disease, especially in cases involving heavily calcified lesions.
Evidence Summary
The available literature includes two studies: a case report and a clinical trial. These studies explore the device's application in treating calcified lesions, with data collected up to 2025.
Reported Outcomes
Published studies report successful use of the FreedomFlow system in treating calcified lesions, including a case of severe calcification in a saphenous vein graft. The device facilitated effective plaque removal, improving patient outcomes in complex scenarios.
Safety Profile
Reported complications include potential vascular injury, particularly in saphenous vein graft interventions. However, specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety and efficacy data. Further research is needed to establish comprehensive safety profiles and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for FreedomFlow Orbital Circumferential Atherectomy System?
The device is indicated for use in atherectomy procedures to treat calcified lesions in peripheral and coronary arteries.
What outcomes have been reported in clinical studies?
Studies report successful plaque removal in calcified lesions, particularly in challenging cases like saphenous vein grafts.
What complications have been reported?
Reported complications include potential vascular injury, especially in saphenous vein graft interventions.
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.