CSI Receives FDA Clearance for Low-Profile, 60-cm Diamondback OAS Device

March 10, 2014—Cardiovascular Systems, Inc. (CSI, St. Paul, MN), announced that it has received US Food and Drug Administration (FDA) clearance of its new Diamondback 360 60-cm peripheral orbital atherectomy systems (OASs) for the treatment of peripheral arterial disease.

According to the company, CSI’s new Diamondback peripheral 60-cm systems are available in two crown designs, the 1.25-mm Micro Crown and the 1.25-mm Solid Crown. Each device offers a shorter shaft length, a smaller profile, and a more flexible shaft than its predecessor for improved ease of use. The device is compatible with 4-F introducer sheaths. The use of smaller sheaths has been shown to reduce procedure times, enable quicker patient recovery, and have less procedural complications from bleeding, noted CSI.

CSI’s low-profile Diamondback 360 peripheral OAS product family builds on the company’s recently released, 4-F–compatible Diamondback 360 1.25 Micro Crown device, which has a 145-cm shaft. The device uses a combination of differential sanding and centrifugal force to reduce arterial plaque, including calcium, which is present in approximately 65% of PAD cases and can cause complications when treating PAD, noted the company.

CSI advised that the Diamondback 360 OASs are 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.

On March 12, CSI announced the first use of the new Diamondback 360 device performed by Jihad A. Mustapha, MD, through tibiopedal access. Dr. Mustapha is the Director of Cardiovascular Catheterization Laboratories, Director of Endovascular Interventions, and Director of Cardiovascular Research at Metro Health Hospital–Metro Heart and Vascular in Wyoming, Michigan.

Dr. Mustapha, who is also the Founder and Director of the AMP: Amputation Prevention Symposium, commented in the company’s press release, “Many of the patients we treat have advanced PAD and suffer from critical limb ischemia. These patients often have complex, calcified lesions in their lower leg, which are challenging to access and treat using the traditional femoral artery access site. CSI’s new orbital atherectomy system now allows us more options to treat those lesions by providing a low-profile system that is fully compatible with alternative access sites in the foot or ankle. Having a variety of treatment options allows us to treat a broader range of patients who may otherwise be facing amputation.”