Cardiovascular Systems Receives Unconditional FDA Approval For ORBIT II Coronary Clinical Trial
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Also Included In: Regulatory Affairs / Drug Approvals ; Heart Disease ; Clinical Trials / Drug Trials
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Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has standard Food and Drug Administration categoric Investigational Device Exemption (IDE) blessing, allowing the society to keep with ORBIT II, a polar test to judge the guard and potency of CSI’s Diamondback 360® System in the coronary arteries. CSI standard conditional IDE commendation for the ORBIT II survey in January 2010. The polar test volition initially enrol up to 100 patients at as many as 50 U.S. sites, with the possible to enter up to 429 patients. Dr. Jeffrey Chambers, an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, is the star tec.


