The Diamondback 360°, an atherectomy device developed by Cardiovascular Systems Inc. of St Paul, Minnesota, received FDA clearance a couple weeks back, and managed somehow to get through our cracks without being reported on. The system is designed for clearing arteries of calcium and other buildup associated with peripheral arterial disease, using a proprietary diamond-coated “orbital” system. Considering its recent approval, the system is being quickly adopted by cardiologists, the company says:
The device differs from existing atherectomy technologies in its ability to remove hard, calcified plaque — in addition to other common kinds of plaque — using a unique “orbiting” action. A tiny, diamond-coated crown uses the principles of centrifugal force to rapidly spin or “orbit” at high speeds and sand away plaque, while preserving the healthy tissue of the arterial wall. According to Dr. P.K. Khanna of Eisenhower Hospital, “The resulting particles are about 75% smaller than red blood cells, which eliminates the need for a distal embolization protection device.” Existing devices have rarely been able to penetrate and effectively remove the “brick wall” of calcium, which has limited physicians’ ability to treat a vast subset of patients.
Within 48 hours of clearance, major medical centers across the country began adopting the new technology. The first doctors successfully completing procedures included Lou Lopez MD, St. Joseph Hospital, IN; Tom Davis MD, Detroit Medical Center, MI; Khusrow Niazi MD, Emory Crawford Long Hospital, GA; P.K. Khanna MD, Eisenhower Hospital, CA; and Daniel Dulas MD, Mercy Medical Center, MN. Dr. Tom Davis of Detroit Medical Center explains, “Up until now, we have not had an effective tool for treating heavily calcified vessels … this technology is a significant breakthrough for treating PAD. The Diamondback 360 allows me the ability to offer my patients almost instantaneous improvement in restoring mobility and/or healing wounds.” Dozens of patients were treated successfully within the first couple of weeks of release.