The Diamondback 360® Coronary Orbital Atherectomy System (OAS) received approval from the U.S. Food and Drug Administration (FDA) this past Tuesday. The device, marketed by Cardiovascular Systems Inc. (CSI), is designed to treat the buildup of calcium in coronary arteries, a contributing factor to heart disease.
According to the American Heart Association, atherosclerosis is the buildup of calcium, cholesterol, or other fatty substances in the inner lining of arteries. When this buildup, known as plaque, starts to cover the entire artery, a heart attack or stroke can occur. While there is no official cause for plaque buildup, certain lifestyle choices have been known to speed up the process, including smoking, poor diet, and physical inactivity.
“Severe coronary arterial calcium is an underestimated problem in medicine, with limited options for treatment,” David L. Martin, president and chief executive officer of Cardiovascular Systems, told Benzinga. “The ORBIT II trial proved our Diamondback technology is safe and effective in treating this complex disease. Securing coronary approval is another key milestone in our mission to provide primary tools for vascular intervention.”
During CSI’s ORBIT II clinical trials, the device showed an 89.1 percent success rate for treating patients with major adverse cardiac events (MACE). Stents were successfully delivered 97.7 percent of the time, and 92.8 percent of patients showed no sign of angiographic complications after 30 days.
The Diamondback 360® Pad System is fitted with a differential sanding mechanism that removes plaque and minimizes damage to the heart’s medial layer. It is electronically driven by a 1.25-mm diamond-coated crown that safely eliminates calcium deposits from coronary blood vessels, CSI’s website states.
“Today is a landmark moment for: patients suffering from calcified coronary artery disease, their families, our physician operators and everyone at CSI,” Martin told Benzinga. “FDA approval of our Diamondback 360 Coronary OAS allows us to bring to market the first new coronary atherectomy system in more than two decades.”