[September 15, 2014] |
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Cardiovascular Systems Releases New Peripheral Data at 2014 TCT Conference
ST. PAUL, Minn. --(Business Wire)--
Cardiovascular Systems, Inc. (CSI (News - Alert)) (NASDAQ:CSII), unveiled new data
about the treatment of arterial calcification at the 2014 Transcatheter
Cardiovascular Therapeutics (TCT) conference in Washington D.C. Arterial
calcium is a common occurrence for the millions of patients suffering
from peripheral artery disease (PAD) and it can lead to significant
complications. Calcified plaque is estimated to be present in
approximately 65 percent of the population treated annually for PAD.
Results from the company's Tissue Removal Assessment with Ultrasound of
the SFA and Popliteal (TRUTH) study, a prospective, single-arm,
non-randomized feasibility study of 25 patients were featured. TRUTH
evaluated the removal of plaque with CSI's Peripheral Orbital
Atherectomy System (OAS) by analyzing changes in plaque volume and
composition via an independent virtual histology (VH) - intravascular
ultrasound (IVUS) core laboratory.
In a poster presentation on Saturday, Sept. 13, 2014, at the Walter E.
Washington Convention Center, physicians Anvar Babaev, M.D., PhD (NYU
Medical Center, New York City), Susanna Zavlunova, M.D. (NYU Langone
Medical Center, New York City), Michael J. Attubato, M.D. (New York
University School of Medicine, New York City) and Akiko Maehara, M.D.
(Cardiovascular Research Foundation and Columbia University
Medical Center, New York City) highlighted TRUTH study results
demonstrating that OAS treatment is effective at reducing and modifying
calcium from lesions, resulting in low acute complications and improved
Rutherford Classification - the scale which measures arterial blockage
severity.
Key TRUTH results included:
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All patients were asymptomatic two weeks after OAS treatment
(Rutherford Classification (RC) of 0 (100% asymptomatic) compared to a
baseline RC of 3 (96.0%);
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100% freedom from recoil, slow flow/no reflow, flow-limiting
dissections or perforations after OAS treatment;
At the treated lesion site, the minimum lumen area increased
significantly from 4.0 mm² to 9.1 mm² post-treatment (p
<0.0001), accompanied by a decrease in area stenosis;
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At the site of maximum calcium removal, calcium reduction was
responsible for 86% of the lumen area increase; and
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Calcium modification was directly related to OAS usage.
David L. Martin, CSI's President and Chief Executive Officer, said,
"TRUTH demonstrates that by using CSI's peripheral atherectomy systems,
physicians can improve procedural success in calcified lesions. The
study also highlights the unique capabilities of our orbital technology
and CSI's commitment to providing physicians new options for treating
the most difficult patients."
About Peripheral Artery Disease (PAD) As many as 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 at double-digit rates. Millions of patients with PAD may benefit
from treatment with orbital atherectomy utilizing the Stealth 360 and
Diamondback 360 Peripheral Orbital Atherectomy Systems, 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 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 and heart 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 for
the treatment of PAD in August 2007. In October 2013, the company
received FDA approval for the use of the Diamondback Orbital Atherectomy
System in coronary arteries. To date, over 157,000 of CSI's devices have
been sold to leading institutions across the United States. For more
information, visit the company's website at www.csi360.com.
Product Disclosure: The Stealth 360® PAD System,
Diamondback 360® PAD System and Predator 360® PAD
System are percutaneous orbital atherectomy systems indicated for use as
therapy in patients with occlusive atherosclerotic disease in peripheral
arteries and stenotic material from artificial arteriovenous dialysis
fistulae. The systems are contraindicated for use in coronary arteries,
bypass grafts, stents or where thrombus or dissections are present.
Although the incidence of adverse events is rare, potential events that
can occur with atherectomy include: pain, hypotension, CVA/TIA (News - Alert), death,
dissection, perforation and distal.
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