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Cardiovascular Systems to Present ORBIT II Two-Year Coronary Data at 2015 Cardiovascular Research Technologies Conference

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Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII) , will release two-year data from its ORBIT II study of the company’s Diamondback 360(R) Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions at the 2015 Cardiovascular Research Technologies (CRT) conference in Washington, D.C., Feb. 21-24, 2015.

The pivotal ORBIT II study evaluated the safety and effectiveness of the company’s orbital atherectomy technology, and CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. In October 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.

It is estimated that significant arterial calcium is present in nearly 40 percent of patients treated with interventional therapies. Calcium can cause complications, including difficult stent deployment, dissections and, when stents are under expanded, it can result in the need for a coronary bypass. Since receiving approval, CSI has continued the controlled commercial launch of its Diamondback Coronary Orbital Atherectomy System (OAS) in the United States and more than 4000 patients have been treated using CSI’s unique technology.

Late Breaking Presentation: ORBIT II Two-Year Data
TITLE: Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute, Minneapolis, Minn., will present “Diamondback 360o Coronary Orbital Atherectomy System for Treating De Novo, Severely Calcified Lesions: 2-Year Results of the Pivotal ORBIT II Trial.”

WHEN: Monday, Feb. 23, 2 p.m.

WHERE: Omni Shoreham Hotel
Ballroom
2500 Calvert Street NW
Washington, DC 20008

Podium Presentation: Advanced Trans-Radial Intervention Masters Course
TITLE: Mitchell W. Krucoff, MD, The Duke Heart Center, Durham, N.C., will present “Calcific Lesions with Left Ventricular Assist: Radial Orbital Atherectomy” as a Masters Course.

WHEN: Monday, Feb. 23, 7:05 a.m.

WHERE: Omni Shoreham Hotel
Blue Room
2500 Calvert Street NW
Washington, DC 20008

Poster Presentations
TITLE: Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute, Minneapolis, Minn., and Arthur Lee, M.D., Interventional Cardiologist, The Cardiac & Vascular Institute, Gainesville, Fla., will present “One-Year Safety Outcomes in Diabetic Patients Treated with Orbital Atherectomy for De Novo, Severely Calcified Coronary Lesions: A Sub-Analysis of the ORBIT II Clinical Trial.”

TITLE: Louis P. Garrison, PhD, University of Washington School of Pharmacy, Seattle, Wash., will present “The Clinical and Cost Burden of Coronary Calcification in a Medicare Cohort: An Economic Model to Address Under-Reporting and Misclassification.”

TITLE: Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute, Minneapolis, Minn., and Arthur Lee, M.D., Interventional Cardiologist, The Cardiac & Vascular Institute, Gainesville, Fla., will present “Orbital Atherectomy Treatment of Severely Calcified Coronary Lesions in Patients with History of Coronary Artery Bypass Grafting: One-Year Safety Outcomes from ORBIT II Trial.”

WHEN: Monday, Feb. 23, 8 a.m.

WHERE: Omni Shoreham Hotel
Exhibit Hall
2500 Calvert Street NW
Washington, DC 20008

Live Demonstration
TITLE: Samin Sharma, MD, The Mount Sinai Hospital Cardiac Cath Lab, New York City, will present a live orbital atherectomy coronary case demonstration.

WHEN: Monday, Feb. 23, 2:20 p.m.

WHERE: Omni Shoreham Hotel
Regency Ballroom
2500 Calvert Street NW
Washington, DC 20008

CRT CME Dinner Symposium Presentations
TITLE: Renu Virmani, MD, CVPath Institute, Inc. Gaithersburg, Md., will present “Calcium in the Peripheral Arteries: The Pathologist View.”
TITLE: Elazer Edelman, MD, CBSET, Inc., Lexington, Mass. and MIT, Cambridge, Mass., will present “Effects of Orbital Atherectomy Treatment on Drug Absorption in Calcified Peripheral Arteries.”
TITLE: Philppe G’en’ereux, MD, Cardiovascular Research Foundation, New York, N.Y., will present “Impact of Coronary Calcified Lesions on Outcome Across Devices.”
TITLE: Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute, Minneapolis, Minn., will present “ORBIT II Clinical and Economic Data Update.”
TITLE: David Cohen, MD, Saint Luke’s Mid America Heart Institute, Kansas City, Mo., will present “MACE Clinical Study Design and Preliminary Data.”
TITLE: Gus Pichard, MD, MedStar Washington Hospital Center, MedStar Heart Institute, Washington, DC, and Azeem Latib, MD, San Raffaele Scientific Institute, Milan, Italy, will present “Vessel Preparation of Calcified Lesions Case Reviews.”

WHEN: Sunday, Feb. 22, 7:30 p.m.

WHERE: Omni Shoreham Hotel
Diplomat Room
2500 Calvert Street NW
Washington, DC 20008

CSI Booth at CRT
Visit CSI at booth #104 11 a.m. – 7:30 p.m. Sunday, Feb. 22; 8 a.m. – 5 p.m. Monday, Feb. 23; and 9 a.m. – 2 p.m. Tuesday, Feb. 24, to meet the company’s calcium experts and learn more about its unique orbital technology.

About Peripheral Artery Disease (PAD)
As many as 18 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 Peripheral Orbital Atherectomy Systems, 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 Coronary Artery Disease
CAD is a life-threatening condition and a 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 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 peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 182,000 of CSI’s devices have been sold to leading institutions across the United States. For more information, visit the company’s website at www.csi360.com.

Product Disclosures:

Peripheral Products

The Stealth 360(R) PAD System and Diamondback 360(R) PAD System 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 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.

Coronary Product
Indications: The Diamondback 360(R) 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% has not been evaluated. See the instructions for use before performing Diamondback 360 Coronary OAS 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.

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