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Cardiovascular Systems to Feature Late-Breaking Coronary Data at SCAI 2014 Scientific Sessions

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), will feature one-year data and an economic analysis from its ORBIT II coronary study in a late-breaking presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2014 Scientific Sessions, taking place in Las Vegas, May 28-31. The ORBIT II study of the company’s Diamondback 360® Coronary Orbital Atherectomy System (OAS) is one of the first to investigate treating severely calcified lesions. CSI also is hosting a lunch symposium on treating coronary and peripheral arterial calcium using orbital atherectomy, and showcasing two poster presentations highlighting additional key coronary data.

The pivotal ORBIT II study evaluated the safety and effectiveness of the company’s orbital atherectomy technology in coronary arteries. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. On October 21, 2013, the company received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital Atherectomy System as a treatment for severely calcified coronary arteries.

Significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention, and contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used—including a substantially higher occurrence of death and major adverse cardiac events.


Late-Breaking Presentation: ORBIT II One-Year Data



“Diamondback 360 Coronary Orbital Atherectomy System for Treating De Novo, Severely Calcified Lesions: ORBIT II 1-Year Results and Cost Comparison to a Sample of Medicare Hospital Claims”—presented by Jeffrey Chambers, M.D., Metropolitan Heart and Vascular Institute, Minneapolis, Minn.



Friday, May 30, 2 p.m. – 3 p.m.


Caesar's Palace, Milano III-IV

Lunch Symposium


“Solutions for Treating Coronary and Peripheral Arterial Calcium Utilizing Orbital Atherectomy”—moderated by Michael R. Jaff, D.O., Institute for Heart, Vascular and Stroke Care, Massachusetts General Hospital, Boston, and George Dangas, M.D., Zena and Michael A. Weiner Cardiovascular Institute, Mount Sinai Medical Center, New York, N.Y.


Presentations include:

-- “Tackling Calcification: Present Options and Future Challenges”—William Gray, M.D., New York-Presbyterian Hospital/Columbia University Medical Center, New York, N.Y.

-- “Orbital Mechanism of Action: Provides Efficacious Coronary Clinical Outcomes”—George Dangas, M.D.

-- “Coronary Case Review”—Richard Shlofmitz, M.D., The Heart Center, St. Francis Hospital, Roslyn, N.Y.

-- “Peripheral Case and Clinical Outcomes Review”—Arthur Lee, M.D., The Cardiac and Vascular Institute, Gainesville, Fla.



Friday, May 30, noon – 1 p.m.


Caesar’s Palace, Pompeian III-IV


Poster Presentations


The following coronary poster presentations will be featured at SCAI:

-- “Outcomes of Elderly Patients Treated with Orbital Atherectomy for De Novo, Severely Calcified Coronary Lesions”—Arthur Lee, M.D., and Jeffrey Chambers, M.D.

-- “Orbital Atherectomy System in Treating Calcified Coronary Lesions: First in Man Assessment – 5-Year Follow Up”—Roosha Parikh, M.D., Cleveland Clinic Foundation, Cleveland, Parloop Bhatt, M.D. and Keyur Parikh, M.D., both with Care Institute of Medical Sciences (CIMS), Ahmedabad, India.



Wednesday, May 28 – Saturday, May 31


Exhibit Hall

CSI Booth at SCAI
Visit CSI at booth #207 Wednesday, May 28, through Saturday, May 31, to meet the company’s calcium experts and learn more about CSI’s unique orbital technology. Exhibit Hours are: Wednesday, May 28: 2:30 p.m. – 7:30 p.m.; Thursday, May 29: 7 a.m. – 6:30 p.m.; Friday, May 30: 7 a.m. – 1 p.m.

About Coronary Artery Disease
Coronary Artery Disease (CAD) is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).

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.

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 146,000 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.

Coronary Product Disclosure
Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Contraindications: The OAS is contraindicated when the VIPERWIRE guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25 percent has not been evaluated.

See the instructions for use before performing DIAMONDBACK 360 coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Peripheral 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.

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