Advertisement
Advertisement
October 18, 2023
Cardio Flow’s FreedomFlow Peripheral Orbital Atherectomy Platform Receives FDA Clearance
October 18, 2023—Cardio Flow, Inc. announced FDA 510(k) clearance for the company’s FreedomFlow orbital atherectomy peripheral platform for the treatment of peripheral artery disease (PAD).
According to the company, the FreedomFlow device treats complex PAD in a wide range of vessel diameters—from 2 mm in the ankle to 8 mm in the hip—and allows for the treatment of multiple arteries and multiple blockages in the same vessel. “The device’s 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,” stated Cardio Flow.
“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,” commented Thomas Davis, MD, in the company’s press release. Dr. Davis is the Director of Cardiovascular Research at Ascension St. John’s Hospital in Detroit, Michigan.
Advertisement
Advertisement
