Cardiovascular Systems to Release Late-Breaking Coronary Data at C3 Conference
June 12 2013 - 11:26AM
Business Wire
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 Orlando, Fla.
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 Orlando,
Fla.
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 orbital technology.
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.
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