Cardio Flow announces US FDA 510(k) clearance for its FreedomFlow orbital atherectomy peripheral platform


Cardio Flow recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow orbital atherectomy peripheral platform.

The company details in a press release that the FreedomFlow platform is designed with a modern mechanism of action to clear plaque blockages in the arteries of the legs. 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. A diamond-coated tip also helps ease the driveshaft through tight blockages.

According to Cardio Flow, this unique approach gives physicians a highly efficient, effective, and flexible way to treat complex peripheral arterial disease (PAD) in a wide range of vessel diameters—from 2mm in the ankle to 8mm in the hip—and greater versatility in treating multiple arteries and multiple blockages in the same vessel, all with a single device.

The company adds that the simplicity of the FreedomFlow platform likewise offers time savings and cost efficiencies, with quick and simple device setup, no capital equipment, no lubricant, and reduced inventory needs. It also provides faster run times, consistent treatment outcomes, and a nearly flat learning curve for physicians, making it an ideal choice for today’s hospitals, ambulatory surgical centres, and office-based labs.

Thomas Davis, director of cardiovascular research at Ascension St John’s Hospital in Detroit, USA, commented: “The incidence of patients presenting with multilevel PAD has increased dramatically in my practice, so having a flexible, efficient, and easy-to-use device that can treat PAD in a broad range of vessel sizes is a key advantage for physicians and patients as we seek to reduce the number of PAD-related amputations.”

Michael J Kallok, CEO of Cardio Flow, stated: “Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development. Many of the existing atherectomy devices on the market have various design constraints and capital equipment costs. With FreedomFlow, we strove to provide physicians with the freedom to treat complex PAD hip to heel with a simple yet sophisticated device that would answer the call for flexible treatment options and cost savings for healthcare systems. We are excited that FreedomFlow will now be available to physicians.”


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