Cardiovascular Systems Receives FDA Approval To Complete Patient Enrollment In ORBIT II Coronary Clinical Trial
Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII) has received FDA approval to complete enrollment of 429 patients in its ORBIT II Investigational Device Exemption (IDE) clinical trial for a coronary application for its Diamondback 360 System. The approval came following FDA review of data from the first 50 cases, as called for in the trial protocol. The ORBIT II trial is evaluating the safety ...