📊 Evidence-Based Reference
Freedomflow Orbital Circumferential Atherectomy System H6004 5Fr 3-sphere Configuration
Summary: The FreedomFlow Orbital Circumferential Atherectomy System by Cardio Flow Inc. is designed for atherectomy procedures. It is primarily used to treat calcified lesions in peripheral arteries. Key evidence includes successful treatment of calcified nodules in saphenous vein grafts.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K233483 ↗
Decision Date ?
February 15, 2024
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The FreedomFlow Orbital Circumferential Atherectomy System was cleared by the FDA via the 510(k) pathway on February 15, 2024. It is manufactured by Cardio Flow Inc. and classified as a Class 2 device.
What It Is
The FreedomFlow Orbital Circumferential Atherectomy System is a medical device used for atherectomy, which involves the removal of plaque from blood vessels. It employs an orbital mechanism to treat calcified lesions, particularly in peripheral arteries.
FDA-Cleared Indications
- Used for atherectomy procedures in peripheral blood vessels.
- Designed to treat stenotic or occlusive lesions, including heavily calcified lesions, in peripheral arteries.
- The H6004 configuration uses a 5 French catheter with a three-sphere orbital treatment mechanism.
Clinical Applications
- Plaque modification before balloon angioplasty in calcified peripheral arterial lesions.
- Treatment of heavily calcified stenoses in lower-extremity peripheral arteries.
- Treatment of peripheral arterial lesions that may be difficult to cross or dilate with balloon angioplasty alone.
- Use during image-guided endovascular procedures to prepare a calcified lesion for subsequent therapy.
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 lesions.
Reported Outcomes
Published studies report successful treatment of calcified nodules in saphenous vein grafts using the FreedomFlow system. The case study highlights its effectiveness in managing severe calcification and critical stenosis.
Safety Profile
Reported complications include the general risks associated with atherectomy procedures, such as potential vascular injury. However, specific adverse events related to the FreedomFlow system are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited to a single case report and a registered clinical trial with no published results. Further research is needed to establish comprehensive safety and efficacy data across diverse patient populations.
Practical Considerations
- The H6004 is a 5 French catheter in a three-sphere configuration; vessel access, guidewire, sheath and compatibility requirements should be confirmed in the current instructions for use.
- Atherectomy is typically performed under fluoroscopic imaging, often through femoral or other peripheral arterial access, with anticoagulation and adjunctive balloon angioplasty or stenting when clinically appropriate.
- The device is intended for trained operators familiar with peripheral endovascular procedures and the management of complications such as dissection, perforation, distal embolization and thrombosis.
- MRI safety information is device-specific and should be verified in the current manufacturer labeling; do not assume the system is MR safe or MR conditional.
- Contraindications, vessel-size limits, lesion-location limits, guidewire requirements and operating parameters should be taken from the current FDA-cleared labeling rather than inferred from the product code.
Frequently Asked Questions
What are the clinical indications for FreedomFlow Orbital Circumferential Atherectomy System?
The device is indicated for the treatment of calcified lesions in peripheral arteries, particularly in cases where traditional interventions are challenging.
What outcomes have been reported in clinical studies?
The case report indicates successful treatment of calcified nodules in saphenous vein grafts, demonstrating the device's effectiveness in managing severe calcification.
What complications have been reported?
Reported complications include potential vascular injury, a general risk associated with atherectomy procedures, but specific adverse events related to this device are not detailed in the evidence provided.
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.