Taking place in the United States and Japan, the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI’s new micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease (CAD). Arthur Lee, M.D., of the North Florida Regional Medical Center in Gainesville, Fla., performed the first procedure.
The micro crown is CSI’s second-generation system designed to facilitate stent delivery in subjects with CAD who are acceptable candidates for percutaneous transluminal coronary angioplasty or stenting. The micro crown OAS is designed to improve the tracking and piloting of the OAS driveshaft and the ability of the crown to reach the lesion while operating at low rotational speeds.
“During my first procedure using CSI’s new micro crown OAS, I modified a calcified lesion allowing stent delivery and expansion,” Lee said.
Building on CSI’s ORBIT II study, the first designed to enroll severely calcified lesions that typically are excluded from all major trials but commonly seen in real world cases, COAST is a prospective, single-arm, multi-center, global, investigational study designed to evaluate the safety and efficacy of CSI’s new micro crown OAS in these difficult to treat lesions.
Up to 100 subjects may be enrolled at up to 15 U.S. sites and five sites in Japan. Minimum enrollment is 50 patients in the United States and 25 in Japan. Gregg Stone, M.D., director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, N.Y., and Shigeru Saito, M.D., director of Cardiology and Catheterization Laboratories at Shonan Kamakura General Hospital in Kamakura, Japan, are the study’s principal co-investigators.
“We’re excited for the potential of CSI’s new micro crown OAS device to provide additional treatment options for heavily calcified lesions seen in the ORBIT II study,” Stone said.
“We’re eager to launch our first international coronary study which will support the approval of our system in the United States and Japan,” said David L. Martin, CSI president/CEO. “COAST aligns with our ORBIT II data protocol and study details—giving CSI a further opportunity to build on the results we delivered in ORBIT II.”
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, the most common form of heart disease. Heart disease claims more than 600,000 lives 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. 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 major adverse cardiac events (MACE).
Based in St. Paul, Minn., Cardiovascular Systems develops and commercializes vascular and coronary disease treatments. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart. The U.S. Food and Drug Administration (FDA) granted the company 510(k) clearance for its Diamondback Orbital Atherectomy System for the treatment of peripheral artery disease in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, over 146,000 of CSI’s devices have been sold across the United States.