Cardiovascular Systems Announces First Peripheral Arterial Disease Case Treated with New, Low-Profile, 60cm Diamondback Peripheral System

Cardiovascular Systems, Inc. (NASDAQ: CSII) (CSI), today announced the first use of its Diamondback 360® 60cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial disease (PAD). Jihad A. Mustapha, M.D., FACC, FSCAI, Director of Heart and Vascular at Metro Health Hospital in Wyoming, Mich., performed the procedure through Tibiopedal access using the new, low-profile device.

Jihad A. Mustapha, M.D., FACC, FSCAI, Director of Heart and Vascular at Metro Health Hospital in Wyoming, Mich., is the first physician in the world to use Cardiovascular Systems' new 60cm Diamondback 360(R) Peripheral Orbital Atherectomy System to treat peripheral arterial disease (PAD). (Photo: Business Wire)

“CSI’s new 60cm, 4 French devices provide physicians with broader treatment options for challenging lesions in the lower leg,” said David L. Martin, CSI president and chief executive officer. “If left untreated, these cases may result in lower limb amputation. Our new 60cm Diamondback devices use smaller sheaths, which have been shown to reduce procedure times and decrease complications from bleeding, enabling quicker patient recovery.”

CSI’s Diamondback 360 Peripheral OAS allows physicians to gain access through the foot or ankle to treat PAD in the small vessels located below the knee due to its very small profile and short length. The recently approved Diamondback 360 60cm Peripheral OAS devices are available in two crown designs, the 1.25mm Micro Crown, and the 1.25mm Solid Crown. Each crown offers a shorter shaft length and a smaller more flexible shaft than their predecessors for improved ease of use.

Said Dr. Mustapha, “Many of the patients we treat have advanced PAD and suffer from Critical Limb Ischemia, or CLI. 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.”

The Diamondback 360 Peripheral OAS uses a patented combination of differential sanding and centrifugal force to reduce arterial plaque, including calcium, which can cause complications when treating PAD. Calcium is present in about 65 percent of the 2.5 million people diagnosed annually with PAD and leads to poor outcomes and higher treatment costs when traditional balloon and stent therapies are used—including dissection, vessel wall trauma and stent fracture.

For more information on the Diamondback 360 Peripheral OAS, contact Cardiovascular Systems, Inc.

About Jihad A. Mustapha, M.D., FACC, FSCAI
Dr. Mustapha is a board-certified interventional cardiologist. He specializes in minimally invasive, non-surgical therapy for heart and peripheral vascular disease. He has advanced training in coronary stent and complex peripheral vascular disease treatments including laser, atherectomy, and totally occluded arteries. Dr. Mustapha graduated from Wayne State University and St. George University School of Medicine. He completed Fellowships in both Cardiology and Interventional Cardiology at Louisiana State University School of Medicine.

Dr. Mustapha is currently in practice at Metro Health Hospital - Metro Heart and Vascular in Wyoming, Michigan, where he is the Director of Cardiovascular Catheterization Laboratories, Director of Endovascular Interventions and Director of Cardiovascular Research. He is a Clinical Assistant Professor at Michigan State University - COM (E. Lansing, MI). Dr. Mustapha is the Founder and Director of the Amputation Prevention Symposium (AMP). He has multiple publications, including those on critical limb ischemia and amputation prevention.

About Peripheral Arterial Disease
More than 12 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing the Stealth 360 and Diamondback 360, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue—a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.

Product Disclosure
The Diamondback 360® Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The peripheral systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.

About Metro Health
An award-winning leader in community healthcare, Metro Health serves more than 250,000 patients annually from across West Michigan – and beyond. In addition to its 208-bed hospital, which provides a comprehensive suite of inpatient and outpatient healthcare services, Metro Health has a growing number neighborhood outpatient centers and offices throughout West Michigan, as well as a community clinic for the underserved and student health clinics at Grand Valley State University and Aquinas College. With more than 500 physicians on staff, Metro Health provides a growing number of specialty health services, including cancer treatment, heart and vascular, neurology, pulmonology and others. Many are members of the Metro Health Medical Group. The hospital is committed to promoting health and wellness through the work of the Metro Health Hospital Foundation, Live Healthy community outreach classes and educational programs and more. Visit us www.metrohealth.net, follow us on Twitter @MetroHealthGr and like us on Facebook/MetroHealth.

About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in August 2007. To date, over 135,000 of CSI’s devices have been sold to leading institutions across the United States. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. For more information, visit the company’s website at www.csi360.com.

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