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Introduction of Orbital Atherectomy expands treatment options for patients with peripheral artery disease.
November 19, 2019
By: Business Wire
Cardiovascular Systems Inc. announced that the first patient in the United Arab Emirates has been treated with its Stealth 360 Peripheral Orbital Atherectomy System (OAS). The first peripheral patient in the Middle East was treated by Dr. Faisal Hasan at the Cleveland Clinic Abu Dhabi, UAE. Dr. Hasan said, “CSI’s orbital atherectomy simultaneously removes calcified plaque within the vessel and modifies medial calcium. This dual mode of action helped restore blood flow and vessel motility in a very challenging peripheral patient. The ability of orbital atherectomy to safely treat calcified peripheral lesions, both above and below the knee, will allow me to serve an unmet need in the United Arab Emirates.” The Stealth 360 PAD System and Diamondback 360 PAD System are percutaneous orbital atherectomy systems (OAS) indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The Stealth 360 PAD System and Diamondback 360 PAD System received U.S. Food and Drug Administration 510(k) clearance. The Stealth 360 PAD System is CE Marked. Scott Ward, chairman, president, and CEO of CSI, said, “In the last year, we have successfully introduced our OAS technology in Asia, Europe and the Middle East. As our distribution partner, OrbusNeich, identifies new markets, we are providing best-in-class training to physicians committed to improving patient outcomes within this underserved patient population.” Cardiovascular Systems Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. OrbusNeich is a global pioneer in the provision of life-changing vascular solutions and offers an extensive portfolio of products that set industry benchmarks in vascular intervention. Current products include the world’s first dual therapy stents, the COMBO Plus and COMBO Dual Therapy Stents, together with stents and balloons marketed under the names of Azule, Scoreflex, Sapphire II, Sapphire II PRO, and Sapphire II NC, as well as products to treat peripheral artery disease: the Jade and Scoreflex PTA balloons. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries.
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