FDA Approves Center Expansion Of Cardiovascular Systems, Inc. Clinical Trial Of The Orbital Atherectomy System

ST. PAUL, Minn., Sept. 18 /PRNewswire/ -- Cardiovascular Systems, Inc. (CSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the expansion of the OASIS clinical trial from ten to 20 centers. The OASIS trial, sponsored by CSI, is being conducted to gather safety and effectiveness data on the Orbital Atherectomy System (OAS). OAS is a catheter-based system that uses a diamond coated crown to remove plaque from peripheral arteries. The novel design of the OAS allows the crown to create a final lumen about twice the size of the crown.

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