November 2, 2014

CSI's Stealth 360º Peripheral Orbital Atherectomy System Gains CE Mark Approval

November 3, 2014—Cardiovascular Systems, Inc. (CSI) announced that it has received CE Mark approval for its Stealth 360º orbital atherectomy system. Stealth 360º is a percutaneous orbital atherectomy system for the treatment of peripheral arterial disease. It is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulas. The system is contraindicated for use in coronary arteries, bypass grafts, stents, or areas where thrombus or dissections are present.

CSI advised that the Stealth 360º device will be available in Europe with a 0.014-inch guidewire platform and crown sizes of 1.25, 1.5, 1.75, and 2 mm. The system consists of the following main components: orbital atherectomy device, saline pump, atherectomy guide wire, and atherectomy lubricant—all of which received CE Mark approval.

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November 2, 2014

CSI's Stealth 360º Peripheral Orbital Atherectomy System Gains CE Mark Approval

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