CSI Launches Diamondback 360 Coronary Orbital Atherectomy Systems

December 3, 2013—Cardiovascular Systems, Inc. (CSI, St. Paul, MN) announced the initial market introduction of its Diamondback 360 coronary orbital atherectomy system (OAS) for the treatment of coronary artery disease. In October 2013, CSI received approval from the US Food and Drug Administration (FDA) to market the device as a treatment for severely calcified coronary arteries.

According to the company, the Diamondback 360 coronary OAS uses a patented combination of differential sanding and centrifugal force to reduce arterial calcium that can cause complications when treating coronary artery disease. It is an eccentrically mounted, 1.25-mm, diamond-coated crown that sands away calcium in coronary arteries, enabling optimal stent deployment. As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion, reducing arterial calcium.

The initial cases in the launch were performed by Manuel Reyes, MD, at Houston Cardiovascular Associates in Houston, Texas; Arthur Lee, MD, at North Florida Regional Medical Center in Gainesville, Florida; and Richard Shlofmitz, MD, at St. Francis Hospital in Roslyn, New York.

“Patients with calcified coronary artery disease are one of the toughest populations to treat. CSI's study results demonstrate that the Diamondback coronary OAS is an effective and safe option for physicians to use when treating severely calcified coronary lesions,” commented Dr. Reyes.

Dr. Lee commented, “Calcification in the coronary arteries is a sign of advanced disease and translates into higher-risk stent procedures; in some circumstances, it even necessitates open heart surgery. The Diamondback 360 coronary OAS gives us the ability to safely and effectively treat these high-risk patients. I fully expect the system will allow widespread uptake of this technology across the country so that all patients will eventually have access to this long-awaited technology.”

Dr. Shlofmitz remarked, “There is a pressing need for treatment of calcified coronary lesions, and the Diamondback 360 coronary OAS addresses that need. CSI's system is safe and effective in treating severely calcified coronary arteries, and, on top of that, it is user-friendly for physicians.”