Cardio Flow’s FreedomFlow Orbital Atherectomy Platform Used in Initial Commercial Cases

November 7, 2023—Cardio Flow, Inc. recently announced the completion of the first commercial cases for the company’s FreedomFlow orbital atherectomy platform, which received FDA clearance in late September. The initial cases were performed by Craig Walker, MD; Pradeep Nair, MD; and McCall Walker, MD, of the Cardiovascular Institute of the South (CIS) at the Terrebonne General Health System in Houma, Louisiana.

According to the company, FreedomFlow treats plaque blockages in the legs. The technology provides physicians with the versatility to treat multiple arteries and multiple blockages in the same vessel with a single device.

The first patient treated at Terrebonne had complex arterial anatomy and multiple blockages with extensive calcium, including a chronic total occlusion. FreedomFlow’s dynamic new mechanism of action demonstrated its effectiveness in these initial procedures, stated the company.

“Peripheral arterial blockages are extremely common, especially in our patients with heart disease,” commented Dr. Nair in Cardio Flow’s press release. “This new technology allows us to treat a wide range of blockages effectively from the ankle to the hip, with the goal of saving limbs—and ultimately our patients’ lives and the quality of those lives.”

The company stated that FreedomFlow’s catheter-based design uses diamond-coated spheres to sand the blockage, leveraging the physics of angular momentum to keep the spheres in constant contact with the vessel wall, whether the device is advancing or retracting. A diamond-coated tip likewise helps physicians ease the driveshaft through tight blockages.

Additionally, Cardio Flow’s CEO Michael Kallok, PhD, announced the appointment of Scott Kraus as Chief Operating Officer.

Kraus has been serving as Vice President of Sales & Marketing for Cardio Flow and was responsible for overseeing all commercial functions. Previously, he worked for Abiomed (now part of Johnson & Johnson MedTech) where he was a Zone General Manager. He has held executive leadership roles at a series of start-ups: Cardiovascular Systems, Inc. (acquired by Abbott), Intact Vascular (acquired by Philips), and Intersect ENT (acquired by Medtronic).

At CSI, Kraus was part of the commercial team at CSI that launched its orbital atherectomy systems; he subsequently became VP of Sales and led the commercial organization in generating $80 million in annual revenue, noted Cardio Flow.