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Cardiovascular Systems to Present ORBIT II Two-Year Coronary Data at 2015 Cardiovascular Research Technologies ConferenceCardiovascular Systems, Inc. (CSI (News - Alert)) (NASDAQ:CSII), will release two-year data from its ORBIT II study of the company's Diamondback 360® Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions at the 2015 Cardiovascular Research Technologies (CRT) conference in Washington, D.C., Feb. 21-24, 2015. The pivotal ORBIT II study evaluated the safety and effectiveness of the company's orbital atherectomy technology, and CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. In October 2013, the company received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital Atherectomy System as a treatment for severely calcified coronary arteries. It is estimated that significant arterial calcium is present in nearly 40 percent of patients treated with interventional therapies. Calcium can cause complications, including difficult stent deployment, dissections and, when stents are under expanded, it can result in the need for a coronary bypass. Since receiving approval, CSI has continued the controlled commercial launch of its Diamondback Coronary Orbital Atherectomy System (OAS) in the United States and more than 4000 patients have been treated using CSI's unique technology.
Late Breaking Presentation: ORBIT II Two-Year
Data WHEN: Monday, Feb. 23, 2 p.m.
WHERE: Omni Shoreham Hotel
Podium Presentation: Advanced Trans-Radial
Intervention Masters Course WHEN: Monday, Feb. 23, 7:05 a.m.
WHERE: Omni Shoreham Hotel
Poster Presentations TITLE: Louis P. Garrison, PhD, University of Washington School of Pharmacy, Seattle, Wash., will present "The Clinical and Cost Burden of Coronary Calcification in a Medicare Cohort: An Economic Model to Address Under-Reporting and Misclassification." TITLE: Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute, Minneapolis, Minn., and Arthur Lee, M.D., Interventional Cardiologist, The Cardiac & Vascular Institute, Gainesville, Fla., will present "Orbital Atherectomy Treatment of Severely Calcified Coronary Lesions in Patients with History of Coronary Artery Bypass Grafting: One-Year Safety Outcomes from ORBIT II Trial." WHEN: Monday, Feb. 23, 8 a.m.
WHERE: Omni Shoreham Hotel
Live Demonstration WHEN: Monday, Feb. 23, 2:20 p.m.
WHERE: Omni Shoreham Hotel
CRT CME Dinner Symposium Presentations WHEN: Sunday, Feb. 22, 7:30 p.m.
WHERE: Omni Shoreham Hotel
CSI Booth at CRT
About Peripheral Artery Disease (PAD) Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy Systems, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue - a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.
About Coronary Artery Disease
About Cardiovascular Systems, Inc. Product Disclosures: Peripheral Products The Stealth 360® PAD System and Diamondback 360® PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA (News - Alert), death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
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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