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June 11, 2014
08:02 EDTCSIICardiovascular Systems enrolls first patient in COAST study
Cardiovascular Systems announced that the first patient has been enrolled in its Coronary Orbital Atherectomy System Trial, or COAST, trial. Taking place in the United States and Japan, the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI’s new micro crown Orbital Atherectomy System in treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease. Dr. Arthur Lee, North Florida Regional Medical Center, Gainesville, Fla., performed the first procedure. Building on CSI’s ORBIT II study, the first study designed to enroll severely calcified lesions that are typically excluded from all major trials but commonly seen in the real world cases, COAST is a prospective, single-arm, multi-center, global, investigational study designed to evaluate the safety and efficacy of CSI’s new micro crown OAS in these difficult to treat lesions.
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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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