Cardiovascular Systems’ Orbital Atherectomy Technology Highlighted at ACC Innovations Forum

  Cardiovascular Systems’ Orbital Atherectomy Technology Highlighted at ACC
  Innovations Forum

Business Wire

ST. PAUL, Minn., & SAN FRANCISCO -- March 12, 2013

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), was featured as part of the
“Innovation and Technology Adoption” presentation during the Innovations
Educational Forum at the 2013 American College of Cardiology (ACC) conference
in San Francisco. Dr. Glen Nelson, CSI’s Chairman of the Board, moderated the
session.

Data presented by Dr. William Gray, Director of Endovascular Services,
Columbia University, New York, N.Y., illustrated that calcified lesions are
underestimated, challenging to treat and lead to increased complications. The
presentation demonstrated the effectiveness of CSI’s peripheral orbital
atherectomy system (OAS) in treating calcified lesions and its ability to
change vessel compliance—minimizing vascular injury that may lead to
restenosis.

Additionally, follow-up on prior CSI studies shared during the forum showed
that CSI’s OAS has consistent procedural outcomes, low complications and
long-term durability in treating calcified lesions.

Click here to see the full abstract.

Also presented at ACC were pivotal trial results from CSI’s ORBIT II study of
patients with severely calcified coronary arteries. ORBIT II is evaluating the
safety and effectiveness of the company’s OAS in treating one of the most
challenging patient populations. At 30 days, patient outcomes exceeded the
study’s primary safety and efficacy endpoint targets by a significant margin.
Moderate to severe arterial calcium is present in nearly 40 percent of
patients undergoing a percutaneous coronary intervention, according to
estimates.

Additionally, 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). A coronary approval 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 2013 to submit its
Premarket Approval application to the Food and Drug Administration.

Click here to see CSI’s ORBIT II Pivotal Trial results.

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 completed 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