FDAnews
www.fdanews.com/articles/81361-csi-announces-ide-approval-to-begin-clinical-trial-of-its-orbital-atherectomy-system-for-peripheral-artery-disease

CSI ANNOUNCES IDE APPROVAL TO BEGIN CLINICAL TRIAL OF ITS ORBITAL ATHERECTOMY SYSTEM FOR PERIPHERAL ARTERY DISEASE

October 3, 2005

Cardiovascular Systems (CSI) recently announced that it has received Conditional Investigational Device Exemption approval from the U.S. Food & Drug Administration. The conditional approval allows CSI to begin its clinical trial of its Orbital Atherectomy System for treatment of peripheral artery disease at two sites.

PRNewswire (http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/09-29-2005/0004135316&EDATE=)