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)

ACC 2013

Business Wire

ST. PAUL, Minn. & SAN FRANCISCO -- March 11, 2013

Cardiovascular Systems, Inc. (CSI) (Nasdaq: 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:

Freedom From MACE                     89.8%  Procedural Success       89.1%
MI (CK-MB >3x ULN                     9.7%    Successful Stent         97.7%
Non Q-wave                             8.8%
Q-wave                                0.9%                            
Target Vessel/Lesion                   1.4%    Less than 50 % residual   98.6%
Revascularization                              stenosis
TVR                                    0.7%
TLR                                   0.7%                            
Cardiac Death                          0.2%    In hospital MACE          9.5%
                                               MI (CK-MB >3x ULN         9.3%
                                               Non Q-wave                8.6%
                                               Q-wave                    0.7%
                                               TVR                       0.7%
                                            Cardiac Death            0.2%

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


Cardiovascular Systems, Inc.
Investor Relations
Sarah Wozniak, 651-259-1636
Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
Dave Folkens, 612-455-1741
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