Cardio Flow, Inc., a privately owned medical device company that specializes in minimally invasive treatments for peripheral artery disease (PAD), has recently announced the receipt of FDA 510(k) clearance for its innovative FreedomFlow Orbital Atherectomy Peripheral Platform. This advanced platform is designed to address arterial plaque blockages in the legs using a modern mechanism of action.

The unique design of the FreedomFlow platform is catheter-based and employs the principles of angular momentum to create a spiral geometry. This innovative approach places five diamond-coated spheres in simultaneous contact with the vessel wall during both advancement and retraction. Additionally, a diamond-coated tip facilitates the passage of the driveshaft through narrow blockages.

This novel technique provides healthcare professionals with a highly efficient and flexible solution for treating complex cases of PAD across a wide range of vessel diameters, from 2 mm in the ankle to 8 mm in the hip. It also offers enhanced versatility for treating multiple arteries and addressing multiple blockages within the same vessel, all achieved with a single device. The simplicity of the FreedomFlow platform offers time and cost efficiencies, with a quick and straightforward device setup that eliminates the need for capital equipment, lubricants, and reduces inventory requirements. The platform also delivers faster run times, consistent treatment outcomes, and a relatively easy learning curve for physicians. This makes it a valuable choice for today's medical facilities, including hospitals, ambulatory surgical centers, and office-based labs.

Source: businesswire.com