FDA Clears New and Modified CSI Diamondback OAS Devices

April 20, 2015—Cardiovascular Systems, Inc. (CSI) announced that it has received US Food and Drug Administration clearance for the new 4-F 1.25 Solid Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment of peripheral artery disease.

The clearance covers the company’s 4-F sheath compatible, new 1.25-mm Diamondback 360 Solid Crown and the 4-F sheath compatible, modified 1.25-mm Diamondback 360 Micro Crown. Both devices have 145-cm lengths.

In the company’s press release, Cezar Staniloae, MD, commented, “CSI’s new 4-F compatible Diamondback devices are redefining interventional vascular medicine. The use of smaller access sheaths has been shown to reduce procedure times, enable quicker patient recovery, and result in fewer procedural complications from bleeding, providing additional procedural benefits to patients and physicians—in addition to expanding physicians’ treatment options.”

The Diamondback 360, as well as CSI’s Stealth 360, are peripheral OAS devices 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, advised the company.