FreedomFlow, a device designed to treat peripheral artery disease (PAD), received FDA clearance earlier this month. Dr. Craig Walker, Dr. Pradeep Naier and Dr. McCall Walker performed the initial U.S. cases with the device. The procedures took place at the Cardiovascular Institute of the South (CIS) at the Terrebonne General Health System in Houma, Louisiana.
Cardio Flow designed FreedomFlow with a modern mechanism of action to clear plaque blockages in the arteries of the legs. The design uses the physics of angular momentum to create a spiral geometry. It puts five diamond-coated spheres in simultaneous contact with the vessel wall. The diamond-coated tip also helps ease the driveshaft through tight blockages.
The first patient treated at Terrebonne had complex arterial anatomy and multiple blockages with extensive calcium. That included a chronic total occlusion. FreedomFlow’s mechanism of action demonstrated its effectiveness in these procedures, Cardio Flow said.
“Peripheral arterial blockages are extremely common, especially in our patients with heart disease,” Nair said. “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.”
Cardio Flow also has a personnel announcement.
CEO Michael Kallok announced that the company promoted Scott Kraus to the role of COO. Kraus most recently served as VP of sales and marketing for Cardio Flow, responsible for overseeing all commercial functions.
Before Cardio Flow, Kraus worked for Abiomed (acquired by Johnson & Johnson) as a zone general manager. Other roles included stints at Cardiovascular Systems, Intact Vascular and Intersect ENT. Those three companies were acquired by Abbott, Philips and Medtronic, respectively.
“We are at a pivotal point at Cardio Flow, and expanding our leadership team in preparation for significant growth is paramount as we launch and scale the organization,” Kallok said. “We believe Scott has the operational and commercial expertise to improve organizational efficiencies and operational strategy to achieve our ambitious goals of delivering a portfolio of innovative endovascular solutions for PAD patients.”
