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Cardiovascular Systems Releases Two-Year ORBIT II Coronary Data in Late-Breaking Presentation at 2015 Cardiovascular Research Technologies ConferenceCardiovascular Systems, Inc. (CSI (News - Alert)) (NASDAQ: CSII), released two-year data from its ORBIT II study of the company's Diamondback 360® Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions in a late-breaking presentation at the at the 2015 Cardiovascular Research Technologies (CRT) conference in Washington, D.C. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. The pivotal study evaluated the safety and efficacy of the company's orbital atherectomy technology in treating patients with de novo severely calcified coronary lesions. ORBIT II was the first IDE 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 (FDA) to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries. Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, Minn. highlighted new data that demonstrated low major adverse cardiac events (MACE) rates, including target lesion revascularization (TLR) and target vessel revascularization (TVR), at two years for this difficult-to-treat patient population. "ORBIT II two-year data reaffirms that CSI's orbital atherectomy technology is a safe and effective treatment option for severely calcified arteries," said Dr. Chambers. "Results continue to show the clinical and economic benefits of this device. Furthermore, we now know that using the coronary OAS device prior to stent placement in severely calcified arteries has shown positive long-term results in a complex and problematic patient population." Dr. Chambers presented the following two-year data:
*Based on reported CK-MB > 3X ULN
Long-term Cost Effectiveness "The two-year results of the ORBIT II study continue to demonstrate positive results following treatment with the Diamondback 360 device in treating severely calcified arteries and CSI's commitment to delivering innovative, durable and cost-effective solutions," said David L. Martin, CSI president and Chief Executive Officer. "Coronary arterial calcium often results in poor clinical outcomes and higher treatment costs, but our two-year results demonstrate significant improvements in both of these areas when our orbital atherectomy technology is employed."
About Coronary Artery Disease
About Cardiovascular Systems, Inc. Product Disclosure
Coronary Product Contraindications: The OAS is contraindicated when the ViperWire guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children. Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the instructions for use before performing Diamondback 360 Coronary OAS procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI's website at www.csi360.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician
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