[May 23, 2013] Cardiovascular Systems Unveils Late-Breaking ORBIT II Coronary Data at EuroPCR Conference Tweet May 23, 2013 (Close-Up Media via COMTEX) -- Cardiovascular Systems, Inc. (CSI), 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, through May 24. In a release, the company noted that 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. 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 WHAT: Dr. Jeffrey W. Chambers, Metropolitan Heart and Vascular Institute, Minneapolis, will present: Pivotal trial to evaluate the safety and efficacy of the Diamondback 360 degrees Orbital Atherectomy System in treating de novo, severely calcified coronary lesions (ORBIT II) WHEN: Thursday, May 23, 10:45 a.m. WHERE: Palais des Congres de Paris Room 351 2 Place Porte Maillot 75017 Paris, France Coronary Artery Disease (CAD) is a life-threatening condition and cause of death in men and women in the United States. Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company. More Information: http://www.csi360.com ((Comments on this story may be sent to [email protected])) [ Back To TMCnet.com's Homepage ]