Cardiovascular Systems to Present Three-Year Orbit I Coronary Data at 2013
Cardiovascular Research Technologies Conference
2013 Cardiovascular Research Technologies conference
ST. PAUL, Minn., & WASHINGTON -- February 19, 2013
Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII), will present three-year data
from its ORBIT I study of coronary artery disease (CAD) in a poster session at
the 2013 Cardiovascular Research Technologies (CRT) conference in Washington,
D.C., Feb. 23-26, 2013.
The ORBIT I study evaluated the safety and efficacy of CSI’s orbital
atherectomy system as a treatment for mild to severely calcified coronary
arteries. Results from the 50-patient feasibility trial show that using CSI’s
technology to treat calcified coronary arteries before stenting achieved
procedural success and compelling long-term outcomes.
It is estimated that moderate to severe arterial calcium is present in nearly
40 percent of patients treated with interventional therapies. Calcium can lead
to poor outcomes and higher treatment costs in coronary intervention when
traditional therapies are used, including a significantly higher occurrence of
death and major adverse coronary events.
The ORBIT I study was CSI’s first trial to collect clinical data on this
subset of patients – people with calcified coronary arteries who were excluded
from the majority of clinical trials previously conducted.
CSI completed enrollment in the ORBIT II trial in November of 2012. ORBIT II
is CSI’s pivotal coronary IDE trial studying this problematic subset of
patients. CSI is targeting the end of this quarter to submit its Premarket
Approval (PMA) package to the FDA.
Poster Session: Feb. 25
WHAT: Dr. Stevan Himmelstein, Baptist Memorial Hospital-Desoto, Memphis,
Tenn., will present “Orbital Atherectomy System in Treating Calcified Coronary
Lesions: First in Man Assessment—Three-Year Follow Up (ORBIT I Trial)” in a
WHEN: Monday, Feb. 25, 8 – 9 a.m.
WHERE: Omni Shoreham Hotel
2500 Calvert Street NW
Washington, DC 20008
CSI Booth at CRT: Feb. 24 – 26
Visit CSI at booth #112 11 a.m. – 7 p.m. Sunday, Feb. 24; 8 a.m. – 5 p.m.
Monday, Feb. 25; and 9 a.m. – 2 p.m. Tuesday, Feb. 26, to meet the company’s
calcium experts and learn more about its 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.
Cardiovascular Systems, Inc.
Sarah Wozniak, 651-259-1636
Investor Relations, 651-259-2800
Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
Dave Folkens, 612-455-1741
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