Cardiovascular Systems Releasing Late-Breaking Confirm Series Data at ISET Conference

  Cardiovascular Systems Releasing Late-Breaking Confirm Series Data at ISET

 Dr. Tony Das Presenting Effectiveness of Orbital Technology in Treating More
                  than 3,100 Patients with Calcified Lesions

ISET Conference 2013

Business Wire

ST. PAUL, Minn. & MIAMI -- January 16, 2013

Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), will present late-breaking
data from its CONFIRM study series, an oral abstract from its CALCIUM study,
and conduct other educational and poster sessions at the 25^th annual
International Symposium on Endovascular Therapy (ISET) conference in Miami,
Jan. 19–23, 2013.

The CONFIRM study series evaluated the safety and procedural effectiveness of
CSI’s orbital atherectomy system as a treatment for peripheral arterial
disease (PAD) —above- and below-the-knee lesions— in a real world population
of patients (no exclusions). Eighty-one percent of the lesions had severe or
moderate calcification—historically considered a difficult patient population
to treat. CONFIRM, like other studies in CSI’s growing body of clinical
research, is aimed at providing physicians with scientific data to make sound
treatment decisions.

Arterial calcification is a common, underdiagnosed condition with complicating
factors—including a higher frequency of dissections and perforations—that pose
a challenge for physicians treating PAD. Calcified lesions are estimated to be
present in approximately 65 percent of the people treated annually for PAD and
are more prevalent in distal vessels below the knee.

ISET Late-Breaking Trial Results Presentation: Jan. 21

WHAT: Dr.  Tony Das, Cardiology and Interventional Vascular Associates,
Dallas, Texas, a significant contributor to the execution and analysis of the
CONFIRM series, will present the late-breaking results.

The CONFIRM series consisted of three real-world studies, using a common
protocol, from 2009 to 2011 that used CSI’s orbital atherectomy systems to
treat more than 3,100 patients (4,700 lesions), 82 percent with moderate to
severe calcium. CSI’s orbital atherectomy system is minimally invasive and
indicated for use as therapy in patients with PAD.

    WHEN:   Monday, Jan. 21, 6:06 p.m.
        WHERE:   The Fontainebleau Miami Beach Hotel
                 4441 Collins Ave.
                 Miami Beach, FL

Additional CSI Presentations and Sessions:
Concurrent Session I: Abstracts and Late-Breaking Trials: Jan. 21

WHAT: Dr. Jonathan Ellichman, Southern Cardiovascular, Memphis, Tenn., will
share Orbital Atherectomy and Balloon Angioplasty vs. Angioplasty Alone in
Critical Limb Ischemia: Results of the CALCIUM 360° Trial in an oral

    WHEN:   Monday, Jan. 21, 5:18 p.m.
        WHERE:   The Fontainebleau Miami Beach Hotel
                 4441 Collins Ave.
                 Miami Beach, FL

CSIQ Educational Session: Jan. 21

WHAT: As part of its medical education program, CSIQ, CSI will host a hands-on
cadaver lab for physicians who want to learn antegrade and retrograde tibial

    WHEN:   Monday, Jan. 21, 6:15 – 8 p.m.
        WHERE:   Splash 21
                 The Fontainebleau Miami Beach Hotel
                 4441 Collins Ave.
                 Miami Beach, FL

Poster Sessions: Jan. 22

WHAT: Dr. Barry Weinstock, Mid-Florida Cardiology Specialists, Orlando, Fla.,
and Dr. Raymond Dattilo (presenter), St. Francis Health Center, Topeka, Kan.,
will present Cost Consequences of Orbital Atherectomy Plus Angioplasty vs.
Angioplasty Alone for Treatment of Calcified Femoropopliteal Lesions in a
poster session.

    WHEN:   Tuesday, Jan. 22, 6 – 7 p.m.
        WHERE:   Fleur de Lis Ballroom
                 The Fontainebleau Miami Beach Hotel
                 4441 Collins Ave.
                 Miami Beach, FL

CSI Booth at ISET: Jan 21 – 23

Visit CSI at booth #406 7:30 a.m. – 4:30 p.m. Monday, Jan. 21, through
Wednesday, Jan. 23, to meet the company’s calcium experts and learn more about
its unique orbital technology.

About Peripheral Arterial Disease

PAD is a life-threatening condition where a fatty material called plaque
builds up on the inside walls of the blood vessels that carry blood from the
heart to legs and arms. The plaque buildup causes the arteries to harden and
narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD
increases if a person has one or several of the following: high blood
pressure, abnormal cholesterol levels, diabetes, or personal history of heart
disease, heart attack or stroke. PAD affects an estimated 8-12 million people
in the United States. The disease prevalence increases with age and 12-20
percent of Americans age 65 and older suffer from PAD symptoms. As the U.S.
population ages, the prevalence range could reach 16 million in those age 65
and older and 19 million overall by 2050.

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, nearly 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, 651-259-2800
Sarah Wozniak, 651-259-1636
Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
Dave Folkens, 612-455-1741
Press spacebar to pause and continue. Press esc to stop.