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# Cardio Flow Orbital Atherectomy Device Cleared
- URL: https://www.fdaweb.com/cardio-flow-orbital-atherectomy-device-cleared/
- Published: 2023-10-19T12:00:00.000Z
- Updated: 2026-09-14T14:13:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155601

FDA has cleared a Cardio Flow510(k) for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform. The device is designed with a “modern mechanism of action” to clear plaque blockages in leg arteries, according to the company. “This proprietary, catheter-based design leverages the physics of angular momentum, creating a spiral geometry that puts five diamond-coated spheres in simultaneous contact with the vessel wall, whether advancing or retracting,” it says, adding that a diamond-coated tip also helps navigate the device through tight blockages. FreedomFlow is cleared for treating vessel diameters from 2 mm in the ankle to 8 mm in the hip.