Cardiovascular Systems, Inc. Completes Enrollment of ECLIPSE Clinical Trial

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the company completed the enrollment of its 2,000 patient ECLIPSE coronary trial.

ECLIPSE is a prospective, multi-center, randomized clinical trial of approximately 2,000 subjects with severely calcified coronary lesions in the United States. Half of the participants received orbital atherectomy prior to drug-eluting stent implantation, while the other half received conventional angioplasty, including specialty balloons, followed by DES implantation. The trial is powered to demonstrate differences in the primary endpoints of post-procedural in-stent minimal cross-sectional area (assessed by Optical Coherence Tomography (OCT) imaging in a subset of approximately 400 patients), as well as in the clinical outcome of target vessel failure at one year. ECLIPSE will also evaluate key health economic outcomes.

Results from ECLIPSE are expected to be shared in the fall of 2024.

Jeffrey W. Chambers, M.D., CSI’s Chief Medical Officer, said, “ECLIPSE is important because it tests two treatment strategies for managing one of the most difficult challenges for interventional cardiologists. We believe the data from this study will be beneficial in defining an optimal treatment plan for patients with severely calcified coronary arteries.”

About Coronary Artery Disease (CAD)

CAD is a life-threatening condition and a leading cause of death in men and women globally. 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 Centers for Disease Control and Prevention, 18 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, arterial calcium is present in 38 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading 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).