Cardio Flow has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its FreedomFlow Orbital Atherectomy Peripheral Platform.
The platform deploys a modern action mechanism for clearing plaque blockages in the arteries of the legs.
Leveraging angular momentum physics, the catheter-based design enables the formation of a spiral geometry that places five diamond-coated spheres in simultaneous contact with the vessel wall, whether advancing or retracting.
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A tip coated with a diamond makes it easier to navigate the driveshaft through narrow blockages.
This approach allows physicians to treat complex peripheral artery disease (PAD) flexibly across a broad spectrum of vessel sizes, ranging from 2mm in the ankle to 8mm in the hip.
It also enhances their ability to treat multiple arteries and blockages within the same vessel using a single device.
