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May 12, 2014
08:38 EDTCSIICardiovascular Systems discloses Civil Investigative Demand
Cardiovascular Systems disclosed late Friday that it received a letter from the U.S. Attorney's Office for the Western District of North Carolina stating that it is investigating the company to determine whether it has violated the False Claims Act, resulting in the submission of false claims to federal and state health care programs, including Medicare and Medicaid. The letter enclosed a Civil Investigative Demand for written interrogatories and document requests. Cardiovascular said, "The Company maintains rigorous policies and procedures to promote compliance with the False Claims Act and other regulatory requirements, and is working with the U.S. Attorney’s Office to promptly respond to the CID. However, the Company cannot predict when the investigation will be resolved, the outcome of this investigation or its potential impact on the Company."
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February 23, 2015
07:07 EDTCSIICardiovascular Systems reports results from preclinical study on Diamondback 360
Cardiovascular Systems announced that CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, disclosed that modification of atherosclerotic plaque with CSI’s Diamondback 360 orbital atherectomy device improved paclitaxel absorption by 50% in calcified cadavaric peripheral arteries. Historically, plaque barriers in arteries have been reported to make drug diffusion and retention more difficult. Results from this ongoing preclinical study were presented by Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, on Sunday, February 22, in a dedicated session on New Strategies for the Treatment of Calcified Lesions at the 2015 Cardiovascular Research Technologies conference in Washington, D.C. Said Dr. Edelman, “The results of our study demonstrated that benign lesion modification with CSI’s orbital atherectomy device improved paclitaxel delivery in human cadaver peripheral arteries with substantial calcified plaque burdens.”
February 18, 2015
07:03 EDTCSIICardiovascular Systems to present Diamondback 360 data at February conference
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