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Freedomflow Orbital Circumferential Atherectomy System
Product: FreedomFlow Orbital Circumferential Atherectomy System — all models and sizes
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 ?
510(k)
Number ?
K231538 ↗
Decision Date ?
September 27, 2023
Product Code ?
MCW Catheter, Peripheral, Atherectomy
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.
FDA-Cleared Indications
- Use in peripheral arteries to perform atherectomy, or plaque removal and modification.
- Intended for treatment of calcified lesions that may limit blood flow or interfere with endovascular therapy.
- The device is classified under FDA product code MCW for peripheral atherectomy catheters.
Clinical Applications
- Debulking or modifying calcified plaque in peripheral artery disease.
- Treatment of heavily calcified lesions during peripheral endovascular intervention.
- Lesion preparation before balloon angioplasty or other catheter-based therapy when plaque limits vessel expansion.
- Treatment of calcified peripheral arterial lesions in anatomically appropriate vessels selected by the treating physician.
Reported off-label uses
- Atherectomy of calcified lesions in saphenous vein grafts has been reported in clinical practice, but this use should be confirmed against the device's current labeling and institutional protocols.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The appropriate catheter size, guidewire, sheath, and other compatible equipment depend on the treated vessel, lesion location, and the device's current instructions for use.
- The system is used under fluoroscopic imaging, typically through percutaneous vascular access such as the common femoral or radial artery when anatomically appropriate.
- Patients may receive local anesthesia with monitored sedation; treatment time varies with lesion length, calcification, and additional interventions.
- MRI safety and conditional-use details should be checked in the current labeling. Do not assume the assembled system or retained components are MRI safe without confirmation.
- Potential complications include vessel dissection or perforation, distal embolization, thrombosis, bleeding at the access site, contrast reactions, kidney injury, and the need for additional treatment.
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.