[Jacksonville, FL, July 15, 2015] – Dr. Omer Zuberi, of First Coast Cardiovascular Institute in Jacksonville, FL, is one of the first in the country to use the Diamondback 360® Coronary Orbital Atherectomy System (OAS) from Cardiovascular Systems, Inc. (CSI). This technology is the first evidence-based, safe treatment approved by FDA for severely calcified coronary lesions. 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 (CAD), a life-threatening condition. Arterial calcium is a common occurrence and can lead to significant complications, with moderate to severe arterial calcium present in nearly 40 percent of patients undergoing a percutaneous coronary intervention in the U.S.
Dr. Zuberi began using the Diamondback 360® Coronary OAS technology earlier this month, in conjunction with Orange Park Medical Center. The Diamondback 360® Coronary OAS is an eccentrically mounted 1.25-millimeter diamond-coated crown that sands away calcium in severely calcified coronary arteries, enabling stent deployment. As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion, reducing arterial calcium, while healthy tissue flexes away. At 30-days, the results from CSI’s ORBIT II clinical study showed that using the Diamondback 360® Coronary OAS technology exceeded the trial’s primary safety and effectiveness endpoints within one of the most challenging patient populations. The primary safety endpoint of 30-day freedom from major adverse cardiac events (MACE) rate was 89.6 percent and the primary effectiveness endpoint of procedural success was 88.9 percent.
This large study of 443 patients at 49 U.S. medical centers supported CSI’s Premarket Approval (PMA) submission, and it was the first Investigational Device Exemption (IDE) study in history to support approval for treating severely calcified coronary lesions.
About Coronary Arterial Disease
Coronary Artery Disease (CAD) is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD. CAD is the most common form of heart disease and claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and MACE.