ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI’s Diamondback 360® System in the coronary arteries. CSI received conditional IDE approval for the ORBIT II study in January 2010. The pivotal trial will initially enroll up to 100 patients at as many as 50 U.S. sites, with the potential to enroll up to 429 patients. Dr. Jeffrey Chambers, an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, is the principal investigator.
