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freedomflow orbital circumferential atherectomy system h6004 5fr 3-sphere configuration
Cardio Flow Inc.,
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
510K
Number
K233483 ↗
Decision Date
February 15, 2024
Product Code
MCW
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.
Clinical Applications
This device is commonly used in clinical scenarios involving heavily calcified lesions in peripheral arteries. It is particularly useful in cases where traditional interventions are challenging due to the extent of calcification.
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.
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.