Cardiovascular Systems to Feature ORBIT II Two-Year and Long-Term Economic Data in Late-Breaking Presentation at the SCAI 2015 Scientific Sessions

ST. PAUL, Minn. & SAN DIEGO--()--Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), will feature two-year results from its ORBIT II trial as well as a long-term economic analysis of the company’s Diamondback 360® Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions in a late-breaking podium presentation at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions in San Diego, Calif., May 6-9.

“Orbital Atherectomy Treatment of Severely Calcified Coronary Lesions: Two-Year Results of the ORBIT II Trial and Long-Term Economic Analysis.”

The pivotal ORBIT II study evaluated the safety and efficacy 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 OAS 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 OAS in the United States and over 6,000 patients have been treated using CSI’s unique technology.

Podium Presentation: ORBIT II Two-Year Data and Long-Term Economic Analysis
TITLE: Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute, Minneapolis, Minn., will present “Orbital Atherectomy Treatment of Severely Calcified Coronary Lesions: Two-Year Results of the ORBIT II Trial and Long-Term Economic Analysis.”

WHEN:
Thursday, May 7, 11:45 a.m.

WHERE:
Hilton San Diego Bay Front Hotel
Indigo ABEF
San Diego, CA

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 200,000 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 Disclosure:

Coronary Product
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% 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.

Contacts

Cardiovascular Systems, Inc.
Jack Nielsen, 651-202-4919
j.nielsen@csi360.com
or
PadillaCRT
Matt Sullivan, 612-455-1709
matt.sullivan@padillacrt.com

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