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freedomflow orbital circumferential atherectomy system
Cardio Flow Inc.,
Summary: The FreedomFlow Orbital Circumferential Atherectomy System by Cardio Flow Inc. is designed for atherectomy procedures. It is FDA 510k cleared and primarily used for treating calcified lesions in peripheral arteries. Key evidence includes successful treatment of calcified nodules in a saphenous vein graft.
FDA Clearance Information
Pathway
510K
Number
K231538 ↗
Decision Date
September 27, 2023
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The FreedomFlow Orbital Circumferential Atherectomy System received FDA clearance through the 510k pathway on September 27, 2023. 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 a medical device used to perform atherectomy, a procedure that removes plaque from blood vessels. It is specifically designed to treat calcified lesions in peripheral arteries by using an orbital mechanism to sand away plaque.
Clinical Applications
This device is commonly used in clinical settings to treat patients with peripheral artery disease, particularly those with heavily calcified lesions that are difficult to manage with standard interventions. It provides an option for debulking plaque in challenging vascular scenarios.
Evidence Summary
The available literature includes two studies: one case report published in 2025 and a clinical trial registered on ClinicalTrials.gov. These studies provide insights into the device's application in treating calcified vascular lesions.
Reported Outcomes
Published studies report successful outcomes in treating calcified nodules in saphenous vein grafts using the FreedomFlow system. The case report highlights the device's ability to manage severe calcification and critical stenosis effectively. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include the general risks associated with atherectomy procedures, such as potential vascular injury. The evidence provided does not specify additional adverse events, indicating a need for further safety data.
Evidence Limitations
The evidence is limited to a single case report and an uncompleted clinical trial, highlighting the need for more comprehensive studies to establish broader efficacy and safety profiles. Further research is required to confirm long-term outcomes and potential complications.
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 arteries.
What outcomes have been reported in clinical studies?
Clinical studies report successful treatment of calcified nodules in saphenous vein grafts, although detailed efficacy metrics are not provided.
What complications have been reported?
Reported complications include potential vascular injury, but specific adverse events are not detailed in the available evidence.
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.