Cardiovascular Systems to Release Late-Breaking Coronary Data at C3
CSI Also Provided Educational Grant for Conference Lunch Symposium
ST. PAUL, Minn. -- June 12, 2013
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), will present data from its
ORBIT II study of coronary artery disease in a late-breaking presentation at
the 2013 Complex Cardiovascular Catheter Therapeutics (C3) conference in
Dr. Jeffrey Chambers, Metropolitan Heart and Vascular Institute, Minneapolis,
will present “Treatment and Procedural Outcomes of the ORBIT II Trial Treating
De Novo Severely Calcified Coronary Lesions” on Thursday, June 20, from 2:10
to 2:25 p.m.
ORBIT II is evaluating the safety and effectiveness of the company’s orbital
atherectomy technology in treating patients with severely calcified coronary
lesions. This is the first Investigational Device Exemption study in history
to evaluate this difficult-to-treat subset of patients. CSI completed ORBIT II
enrollment of 443 patients at 49 U.S. medical centers in November 2012 and
submitted its Premarket Approval application to the FDA on March 15, 2013.
CSI also provided an educational grant for the upcoming C3 Orbital Atherectomy
System Lunch Symposium.
Lunch Symposium: June 19
WHAT: Leading peripheral arterial disease physicians will share their
expertise during a lunch symposium at C3. The symposium will cover peripheral
calcified lesions and the usage of orbital atherectomy for plaque
modification, as well as advanced techniques to maximize outcomes, and more.
WHEN: Wednesday, June 19, 12 – 2 p.m.
WHERE: Gatlin A3, A4
Rosen Shingle Creek
9939 Universal Boulevard
SCHEDULE: 12 – 12:15 p.m.: Impact of Calcified Lesions and Changing Vessel
Compliance with Orbital Atherectomy, Jihad Mustapha, MD, FSCAI
12:15 – 12:30 p.m.: Clinical Evidence Supporting Use of Orbital
Atherectomy for Plaque Modification: From Randomized Trials to
Registry Data, Raymond Dattilo, MD
12:30 – 12:45 p.m.: Orbital Atherectomy: Advanced Techniques to
Maximize Outcomes, Utpal Desai, MD
12:45 – 1:30 p.m.: Prerecorded Case Transmission
1:30 – 1:45 p.m.: Case Presentation
1:45 – 2 p.m.: Case Presentation
CSI Booth at C3: June 17 – 21
Visit CSI at booth #200 from 8 a.m. to 5 p.m. Monday, June 17, through Friday,
June 21, to meet the company’s calcium experts and learn more about its unique
About Peripheral Arterial Disease
As many as 8 million to 12 million Americans, most over age 65, suffer from
PAD, which is caused by the accumulation of plaque in peripheral arteries
(commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain
when walking or at rest. Left untreated, PAD can lead to severe pain,
immobility, non-healing wounds and eventually limb amputation. With risk
factors such as diabetes and obesity on the rise, the prevalence of PAD is
growing faster than the rest of the population.
Millions of patients with PAD may benefit from treatment with orbital
atherectomy utilizing the Stealth 360° and Diamondback 360°, minimally
invasive catheter systems developed and manufactured by CSI. These systems use
a diamond-coated crown, attached to an orbiting shaft, which sands away plaque
while preserving healthy vessel tissue — a critical factor in preventing
reoccurrences. Balloon angioplasty and stents have significant shortcomings in
treating hard, calcified lesions. Stents are prone to fractures and high
recurrence rates, and treatment of hard, calcified lesions often leads to
vessel damage and suboptimal 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, nearly 110,000
of CSI’s devices have been sold to leading institutions across the United
States. CSI has also 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.
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
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