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Medical Devices / Regulatory Affairs / Submissions and Approvals

Cardiovascular Systems Gets FDA Nod for Diamondback Device

March 11, 2014

St. Paul, Minn.-based Cardiovascular Systems said Monday its suite of minimally invasive Diamondback 360 60cm Peripheral Orbital Atherectomy Systems has received FDA clearance for use in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.

President and CEO David Martin commented that the Diamondback 360 60cm “provides physicians with  broader treatment options for challenging lesions in the lower leg, often associated with Critical Limb Ischemia, … which if left untreated may result in lower limb amputation.”

The newly cleared system is contraindicated in coronary arteries, bypass grafts, stent or anywhere in which thrombus or dissections exists. Cardiovascular Systems already makes a Diamondback product for use in coronary atherectomy.

The company plans to make the newly cleared system available in the U.S. by mid-April. — Lena Freund

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