Cardio Flow secures FDA 510(k) approval for FreedomFlow atherectomy platform
19 Oct 2023
FreedomFlow orbital atherectomy peripheral platform is designed to clear the plaque blockages formed in the arteries of the legs, using an advanced mechanism of action, and supports a broad range of vessel diameters, from 2mm in the ankle to 8mm in the hip
FreedomFlow Orbital Atherectomy Platform. (Credit: Business Wire)
US-based medical devices firm Cardio Flow has received the US Food and Drug Administration (FDA) 510(k) approval for its FreedomFlow orbital atherectomy peripheral platform.
The FreedomFlow platform is designed to incorporate an advanced mechanism of action to clear the blockages formed in the arteries of the legs, due to the accumulation of plaque.
Its unique catheter-based design uses angular momentum to create a spiral geometry that enables the five diamond-coated spheres to be in contact with the vessel wall.
The FreedomFlow platform also features a diamond-coated tip that enables the driveshaft to easily navigate through tight blockages, said the medical device maker.
Cardio Flow CEO Michael Kallok said: “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.”
Cardio Flow said that the unique approach of the FreedomFlow platform provides physicians with an effective and flexible way to treat complex peripheral arterial disease (PAD).
It supports a broad range of vessel diameters, from 2mm in the ankle to 8mm in the hip and is flexible in treating multiple arteries and blockages in the same vessel, with a single device.
The FreedomFlow platform enables time savings and cost efficiencies, with rapid and simple device setup, requires no capital equipment, or lubricant, and reduced inventory needs.
It also provides quicker run times, consistent treatment outcomes, and a nearly flat learning curve for physicians, and is suitable for hospitals, ambulatory surgical centres, and office labs.
Ascension St. John’s Hospital cardiovascular research director Thomas Davis said: “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.”
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