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February 25, 2014
07:12 EDTCSIICardiovascular Systems releases one-year ORBIT II coronary data
Cardiovascular Systems released one-year data from its ORBIT II study of the company’s Diamondback 360 Coronary Orbital Atherectomy System in treating severely calcified lesions at the 2014 Cardiovascular Research Technologies conference in Washington, D.C. Results were presented as part of CRT’s iMPACT Trials, which are innovative reports that provide the latest breakthroughs in clinical science. The studies selected for the iMPACT Trials session at CRT highlight new improvements for quality of patient care, and significantly impact the field of interventional cardiology. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. The pivotal study evaluated the safety and effectiveness of the company’s orbital atherectomy technology in treating patients with severely calcified coronary lesions. ORBIT II is the first study in history to evaluate this problematic subset of patients. In October 2013, CSI received PMA approval from the U.S. Food and Drug Administration to market its Diamondback 360 Coronary Orbital Atherectomy System as a treatment for severely calcified coronary arteries. “Patients with severe coronary calcium are more likely to experience major adverse events, or even death, and treatment of severely calcified coronary arteries remains a challenge,” said Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis. “However, one-year results from the ORBIT II study reaffirm what we learned from the 30-day data: CSI's orbital atherectomy technology is a practical treatment that continues to demonstrate durable outcomes. Physicians have a new option to treat severe coronary calcium.”
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