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Home » FDA clears Cardio Flow’s FreedomFlow orbital atherectomy peripheral platform

FDA clears Cardio Flow’s FreedomFlow orbital atherectomy peripheral platform

October 19, 2023 By Danielle Kirsh

[Image courtesy of Cardio Flow]
Cardio Flow this week received FDA 510(k) clearance for its FreedomFlow orbital atherectomy peripheral platform.

The St. Paul, Minnesota-based company designed FreedomFlow with a modern mechanism of action to clear plaque blockages in the arteries of the legs. The catheter-based design uses the physics of angular momentum, creating a spiral geometry that puts five diamond-coated spheres in simultaneous contact with the vessel wall. The diamond-coated tip also helps ease the driveshaft through tight blockages.

“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,” CEO Michael Kallok said in a new release. “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.”

FreedomFlow’s approach gives physicians an efficient, effective and flexible way to treat complex peripheral artery disease (PAD) in a wide range of vessel diameters, including from 2mm in the ankle to 8mm in the hip. It has greater versatility in treating multiple arteries and multiple blockages in the same vessel.

“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, the Director of Cardiovascular Research at Ascension St. John’s Hospital in Detroit, Michigan.

Filed Under: Business/Financial News, Cardiovascular, Catheters Tagged With: Cardio Flow

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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