FreedomFlow® Orbital Atherectomy Peripheral Platform Receives Regulatory Approval from Cardio Flow, Inc.

Cardio Flow, a private medical device firm focusing in minimally invasive peripheral artery disease (PAD) treatments, has received FDA 510(k) clearance for its FreedomFlow Orbital Atherectomy Peripheral Platform.

The innovative FreedomFlow platform employs an angular momentum-based mechanism to effectively remove arterial plaque blockages in the legs. Its catheter design, featuring diamond-coated spheres and a specialized tip, ensures consistent contact with vessel walls, facilitating smooth navigation through tight blockages.

This distinctive method offers physicians an efficient and flexible solution for treating complex peripheral artery disease across various vessel diameters, enabling versatile treatment of multiple arteries and blockages using a single device.

With no capital equipment or lubricant requirements, the streamlined FreedomFlow platform saves time and money. Its quick operation assures consistent results and an easy learning curve for physicians, making it an ideal choice for a variety of medical facilities.

The simplified FreedomFlow platform saves time and money by requiring no capital equipment or lubricant. It guarantees efficient operation, consistent results, and a short learning curve, making it an excellent choice for a variety of medical establishments.

Dr. Thomas Davis, M.D., Director of Cardiovascular Research at Ascension St. John’s Hospital in Detroit, MI, and a recognized leader in the treatment of PAD and critical limb-threatening ischemia, stated, “The incidence of patients presenting with multi-level 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.”

Further, Michael J. Kallok, Ph.D., CEO of Cardio Flow, commented, “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’re excited that FreedomFlow will now be available to physicians.”

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