Data From Clinical Trial Evaluating Cardiovascular Systems’ Diamondback 360° to Treat Above-the-Knee Peripheral Arterial D...

EMBARGOED UNTIL 9:30 A.M. CT, April 5, 2011

ACC i2 Poster Contributions Session No. 2516 (Poster #507)

WHAT: Principal Investigator Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan., will present preliminary acute results of the COMPLIANCE 360° study.

The COMPLIANCE 360° is a prospective, randomized multicenter feasibility study that examines whether the Diamondback 360º PAD System, by improving lesion compliance through differential sanding, can achieve satisfactory acute and durable results without the need for stent placement. In the COMPLIANCE 360° study, 50 patients were enrolled at nine U.S. sites. The Diamondback 360º PAD System is a minimally invasive orbital atherectomy system indicated for use as therapy in patients with peripheral arterial disease (PAD) – blockages in leg arteries.

WHEN: Tuesday, April 5, 9:30 a.m. – 10:45 a.m.

WHERE: Hall F, Ernest N. Morial Convention Center, 900 Convention Center Blvd., New Orleans

THE CV Innovations Educational Forum

WHAT: Drs. Stevan Himmelstein, Baptist Memorial Hospital-Desoto, Memphis, Tenn., and Jeffrey Chambers, Mercy Hospital, Minneapolis will provide an overview of their use of the Diamondback 360° at the ACC CV Innovations Forum, which features cutting-edge research and product development. They will discuss their clinical experience with CSI’s orbital technology for peripheral and coronary applications, along with highlights of CSI’s clinical data with an emphasis on small, calcified vessels.

WHEN: Monday, April 4:

9:45 a.m.: Advancing the Standard of Care for Treating PAD, Dr. Himmelstein
10 a.m.: The Future of Coronary Interventions, Dr. Chambers

WHERE: Exhibit Hall Stage, Ernest N. Morial Convention Center

ABOUT CSI AND PAD: PAD is a life-threatening condition where a fatty material called plaque builds up on the inside walls of the blood vessels that carry blood from the heart to legs and arms. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD increases if a person has one or several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or personal history of heart disease, heart attack or stroke. More than 12 million people in the United States suffer from PAD. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.

In April 2010, CSI also received FDA unconditional IDE approval for ORBIT II, a pivotal trial to evaluate the safety and efficacy of the Diamondback 360° in coronary arteries. A coronary indication for calcified lesions represents a large, underserved market opportunity. CSI completed enrollment of 50 patients for Phase I of the ORBIT II trial. ORBIT II is expected to enroll 429 patients, subject to FDA review of data from the first 50 cases.

Visit CSI at booth #4458, i2 Summit Interventional Pavilion, 9:30 a.m.-4:45 p.m. Sunday, April 3 or Monday, April 4, or 9:30 a.m.-1:30 p.m. Tuesday, April 5.

INTERVIEW OPPORTUNITIES: Interviews can be requested by contacting Nancy Johnson, (612) 455-1745 (o), (612) 812-7568 (c) njohnson@psbpr.com, or Nick Banovetz (612) 455-1705 (o) or (651) 815-5999 (c), Padilla Speer Beardsley.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing interventional treatment systems for vascular disease. For more information visit the company’s Web site at www.csi360.com.

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