Cardio Flow’s FreedomFlow Orbital Atherectomy Peripheral Platform Earns FDA Nod

Cardio Flow has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its FreedomFlow orbital atherectomy peripheral platform.
 
Designed with a modern mechanism of action to clear leg artery blockages, FreedomFlow leverages the physics of angular momentum to create a spiral geometry that puts five diamond-coated spheres in simultaneous contact with the vessel wall, whether advancing or retracting. The diamond-coated tip also helps ease the driveshaft through tight blockages, according to the company.
 
The approach allows treating peripheral artery disease (PAD) in vessel diameters from 2 mm in the ankle to 8 mm in the hip. It also allows versatility to treat multiple arteries and multiple blockages in the same vessel, Cardio Flow said.
 
“Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development,” Cardo Flow’s CEO Michael J. Kallok told the press. “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.”
 
The FreedomFlow platform doesn’t need capital equipment or lubricant. The company said it offers faster run times, consistent outcomes, and a nearly flat learning curve.
 
“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,” said Dr. Thomas Davis, M.D., the Director of Cardiovascular Research at Ascension St. John’s Hospital in Detroit, Mich.