Cardiovascular Systems Presents Results from Pivotal Coronary Trial at ACC

Cardiovascular Systems Presents Results from Pivotal Coronary Trial at ACC

ORBIT II trial met its primary endpoints treating one of the most challenging patient populations:

• 100 percent of patients had severe coronary calcification—a patient subset never before studied

• At 30 days, patient outcomes exceeded the study's primary safety and efficacy endpoint targets by a significant margin

  • 30-day freedom from MACE rate of 89.8 percent

  • Procedural success of 89.1 percent (including in-hospital MACE)

ST. PAUL, Minn. & SAN FRANCISCO--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , presented pivotal 30-day data from its ORBIT II study of severely calcified coronary lesions at the 2013 American College of Cardiology (ACC) conference in San Francisco. The Featured Clinical Research session presentation by Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, demonstrated that CSI's technology produced clinical outcomes that exceeded the trial's two primary endpoints by a significant margin—within one of the most challenging patient populations to treat.

ORBIT II is evaluating the safety and effectiveness of the company's orbital atherectomy technology in treating a problematic subset of patients with severely calcified coronary lesions and is the first Investigational Device Exemption (IDE) study in history to seek approval for treating these lesions. According to estimates, moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012.

Dr. Chambers presented the following 30-day data:

Read the full abstract here.

"While treatment of severely calcified coronary arteries remains a challenge, 30-day ORBIT II results show that study endpoints were met by a significant margin, and demonstrate that CSI's orbital atherectomy system may be a viable treatment option," said Dr. Chambers. "ORBIT II represents the only study to-date of this hard-to-treat patient population. Past studies haven't attempted to treat severely calcified lesions, due to the challenge of meeting endpoints and overall treatment success."

Moderate-to-severe 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 coronary events (MACE). Coronary approval would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States. CSI is targeting the end of March to submit its Premarket Approval (PMA) application to the Food and Drug Administration (FDA).

David L. Martin, CSI president and chief executive officer, added: "CSI's mission is to conquer calcified arterial disease. Coronary arterial calcium is an extremely underserved problem. The ORBIT II study results for this sickest-of-the-sick patient population demonstrate the outstanding performance of our orbital atherectomy technology. We are very excited about the future of our coronary franchise and look forward to continuing down the path for FDA approval of this unique technology."

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 several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. CAD affects an estimated 16.8 million people in the United States and is the most common form of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year.

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 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 100,000 of CSI's devices have been sold to leading institutions across the United States. CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.

For more information, visit the company's website at www.csi360.com.

Cardiovascular Systems, Inc.
Investor Relations
651-259-2800
investorrelations@csi360.com
or
Sarah Wozniak, 651-259-1636
swozniak@csi360.com
or
Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
msullivan@padillaspeer.com
or
Dave Folkens, 612-455-1741
dfolkens@padillaspeer.com

KEYWORDS: United States North America California Minnesota

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