Cardiovascular Systems Releasing Late-Breaking ORBIT II Coronary Data at EuroPCR Conference

ST. PAUL, Minn.--(BUSINESS WIRE)--

Cardiovascular Systems, Inc. (CSI) (CSII), will present late-breaking data from its ORBIT II study of coronary artery disease at the 2013 European Association of Percutaneous Cardiovascular Interventions (EuroPCR) conference in Paris, May 21–24, 2013.

ORBIT II is evaluating the safety and effectiveness of the company’s orbital atherectomy technology in treating patients with severely calcified coronary lesions. This is the first Investigational Device Exemption study in history to evaluate this difficult-to-treat subset of patients. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012 and submitted its Premarket Approval application to the FDA on March 15, 2013.

According to estimates, moderate-to-severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. 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.

EuroPCR Late-Breaking Trial Results Presentation: May 23

About Coronary Artery 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 several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. CAD affects an estimated 16.8 million people in the United States and is the most common form of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in August 2007. To date, nearly 110,000 of CSI’s devices have been sold to leading institutions across the United States. CSI has also completed its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.

For more information, visit the company’s website at www.csi360.com.