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Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013 American College of Cardiology Conference



  Cardiovascular Systems to Present Pivotal Orbit II Coronary Data at the 2013
  American College of Cardiology Conference

Business Wire

ST. PAUL, Minn., & SAN FRANCISCO -- March 4, 2013

Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), will present data from its
ORBIT II study of coronary artery disease at the 2013 American College of
Cardiology (ACC) conference in San Francisco, Mar. 9–11, 2013. This marks the
first time CSI will share results from this landmark pivotal trial, which is
the first Investigational Device Exemption (IDE) study in history to seek
approval for treating severely calcified coronary lesions.

ORBIT II is evaluating the safety and effectiveness of the company’s orbital
atherectomy technology in treating this problematic subset of patients.
Moderate to severe arterial calcium is present in nearly 40 percent of
patients undergoing a percutaneous coronary intervention, according to
estimates. 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. A coronary application would open up a large, underserved
market opportunity for CSI, estimated to exceed $1.5 billion annually in the
United States.

CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers
in November 2012. CSI is targeting the end of March to submit its Premarket
Approval application to the Food and Drug Administration (FDA).

 
Oral Presentation at ACC: Mar. 9
 
WHAT: Dr. Jeffrey W. Chambers, Mercy Hospital, Coon Rapids, Minn., will
present “Pivotal Trial to Evaluate the Safety and Efficacy of Diamondback 360°
Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary
Lesions (ORBIT II).”
 
                    WHEN:                        Saturday, Mar. 9, 2:15 – 2:30
                                                 p.m.
 
                    WHERE:                       Moscone Center West
                                                 Room 3001
                                                 800 Howard Street
                                                 San Francisco, CA 94103
 
 
Poster Sessions at ACC: Mar. 9 – 10
 
WHAT: Dr. Philippe Genereux, Columbia University Medical Center, New York,
will share data as a contributor to the poster presentation “Impact of
Coronary Calcification on 1-Year Outcomes after PCI in STEMI and NSTEMI:
Pooled Analysis from HORIZONS and ACUITY trials.”
 
                    WHEN:                        Saturday, Mar. 9, 3:45 – 4:30
                                                 p.m.
 
                    WHERE:                       Moscone Center
                                                 Expo North
                                                 800 Howard Street
                                                 San Francisco, CA 94103
 
WHAT: Dr. Genereux will also contribute to the poster presentation
“Association between Coronary Calcification and Bleeding after PCI in Acute
Coronary Syndromes: Pooled Analysis from HORIZONS-AMI and ACUITY Trials.”
 
                    WHEN:                        Sunday, Mar. 10, 9:45 – 10:30
                                                 a.m.
 
                    WHERE:                       Moscone Center
                                                 Expo North
                                                 800 Howard Street
                                                 San Francisco, CA 94103
 
ACC Educational Forum: Mar. 11
 
WHAT: Dr. Glen Nelson, CSI chairman, is moderating the “Innovation and
Technology Adoption” presentation during ACC’s Innovations Educational Forum.
 
                    WHEN:                        Monday, Mar. 11, 11:40 a.m. –
                                                 12:30 p.m.
 
                    WHERE:                       Moscone Center
                                                 Expo North, CV Forum #N5206
                                                 800 Howard Street
                                                 San Francisco, CA 94103
 
This presentation is not part of ACC.13, as planned by its Program Committee,
and does not qualify for continuing medical education (CME), continuing
nursing education (CNE) or continuing education (CE) credit.
 

CSI Booth at ACC: Mar. 9 – 11

Visit CSI at booth #N6257 9:30 a.m. – 4:45 p.m. Saturday, Mar. 9, and Sunday,
Mar. 10; and 9:30 a.m. – 2 p.m. Monday, Mar. 11, to meet the company’s calcium
experts and learn more about CSI’s unique orbital 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.

Contact:

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
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