đź“Š Evidence-Based Reference
freedomflow orbital circumferential atherectomy system
Cardio Flow Inc.,
Summary: The FreedomFlow Orbital Circumferential Atherectomy System is a device used for atherectomy procedures, primarily in treating calcified lesions. Key evidence includes its use in challenging saphenous vein graft interventions.
FDA Clearance Information
Pathway
510K
Number
K242947 ↗
Decision Date
November 5, 2024
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 November 5, 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 designed to remove plaque from arteries, particularly in cases of severe calcification. It operates by orbiting a diamond-coated crown to sand away plaque, facilitating improved blood flow.
Clinical Applications
This device is commonly used in peripheral artery disease interventions, especially where calcified lesions are present. It is also applied in complex cases such as saphenous vein grafts where traditional methods may pose higher risks.
Evidence Summary
The available literature includes two studies: one case report and one clinical trial. The studies explore the device's application in complex vascular scenarios, with publication dates ranging from 2025 to ongoing.
Reported Outcomes
Published studies report successful treatment of calcified lesions in saphenous vein grafts using the FreedomFlow system. The device has shown efficacy in reducing stenosis and improving blood flow in heavily calcified arteries.
Safety Profile
Reported complications include the potential for vascular injury, particularly in delicate or heavily calcified vessels. 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 outcomes. Further research is needed to establish long-term efficacy and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for FreedomFlow Orbital Circumferential Atherectomy System?
The device is indicated for use in atherectomy procedures, particularly in treating calcified lesions in peripheral arteries and saphenous vein grafts.
What outcomes have been reported in clinical studies?
Studies have reported successful reduction of stenosis and improved blood flow in calcified lesions.
What complications have been reported?
Safety data indicate potential for vascular injury, though specific adverse events were 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.