Cardiovascular Systems Announces Orbit II Evaluating Atherectomy Technology, Met Primary Endpoint

Cardiovascular Systems, Inc. (CSI)

, presented 30-day results from its ORBIT II study of coronary artery disease in a late-breaking presentation at the 2013 European Association of Percutaneous Cardiovascular Interventions (EuroPCR) conference in Paris. 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 problematic 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. Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, highlighted new data showing that 92.8 percent of patients were free from severe angiographic complications at 30 days. Additionally, core lab assessed final procedure residual stenosis was 4.7 percent. “Patients who suffer from severely calcified coronary lesions are one of the toughest-to-treat populations, and 30-day ORBIT II results demonstrate that CSI's orbital atherectomy technology may be a practical treatment option,” said Dr. Chambers. “Patients with moderate-to-severe calcium are more likely to experience major adverse coronary events (MACE), or even death. To have a potential solution for this problem is exciting.” Dr. Chambers also presented the following 30-day data:                   Freedom From MACE (30 Day)   89.8%       Procedural Success   89.1% MI (CK-MB >3x ULN   9.7% Successful Stent   97.7% Delivery Non Q-wave 8.8% Q-wave   0.9%       Target Vessel/Lesion 1.4% Less than 50 % residual 98.6% Revascularization stenosis TVR 0.7% TLR   0.7%       Cardiac Death 0.2% In hospital MACE 9.5% MI (CK-MB >3x ULN 9.3% Non Q-wave 8.8% Q-wave 0.9% TVR 0.7%             Cardiac Death   0.2%   According to estimates, moderate-to-severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. Moderate-to-severe 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. David L. Martin, CSI president and chief executive officer, said: “Coronary arterial calcium is a significantly underestimated problem in medicine today. We are committed to providing physicians with viable treatment options for this devastating disease and we are encouraged by the ORBIT II results, which demonstrate that our orbital technology may provide a solution for these difficult to treat patients.”