Primary Treatment with Diamondback
360® Orbital Atherectomy System Improved Drug Uptake
in Cadaveric Peripheral Arteries;
ORBIT II Two-year Data Demonstrates Durable
Clinical and Economic Results
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII) today
announced that CBSET, a not-for-profit preclinical research
institute dedicated to biomedical research, education and
advancement of medical technologies, presented pre-clinical study
data at the 2015 European Association of Percutaneous
Cardiovascular Interventions (EuroPCR) conference taking place May
19-22, 2015, in Paris, France.
Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET,
presented data showing that primary treatment with CSI’s
Diamondback 360® Orbital Atherectomy System (OAS) improved
paclitaxel absorption by 50 percent in calcified cadaveric
peripheral arteries. Historically, calcified plaque barriers in
arteries have been reported to make drug diffusion and retention
more difficult.
David L. Martin, President and Chief Executive Officer of
Cardiovascular Systems, Inc., said, “We remain steadfast in our
pursuit of critical and actionable clinical data. We continue to be
encouraged by the ongoing study of CSI’s unique orbital atherectomy
mechanism of action and how it may help facilitate improved drug
absorption and peripheral patient outcomes when calcium is present.
With this, we will continue to study the use of OAS as the primary
treatment for arterial calcium with drug-coated-balloon
therapy.”
Martin also indicated that Dr. Jeffery Chambers presented a
Late-Breaking Clinical Trial Hot-line presentation on the two-year
results from its ORBIT II trial at EuroPCR 2015, as well as a new
two-year extrapolated economic analysis of the company’s
Diamondback 360 Coronary OAS in treating severely calcified
lesions. The Diamondback 360 Coronary OAS has been associated with
a short length of stay for patients when the device was used to
treat severely calcified lesions to facilitate stent placement. The
low incidence of readmission and short length of stay provide an
estimated cost savings of up to $4,946 per patient to the treating
institution at two years following the procedure.
About Peripheral Artery DiseaseAs many as 18 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 Coronary Artery DiseaseCAD is a life-threatening
condition and a 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 more of the following: high blood pressure,
abnormal cholesterol levels, diabetes, or family history of early
heart disease. According to the American Heart Association, 16.3
million people in the United States have been diagnosed with CAD,
the most common form of heart disease. Heart disease claims more
than 600,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in nearly 40
percent of patients undergoing a percutaneous coronary intervention
(PCI). Significant calcium contributes to poor outcomes and higher
treatment costs in coronary interventions when traditional
therapies are used, including a significantly higher occurrence of
death and major adverse cardiac events (MACE).
About CBSETCBSET — Concord Biomedical Sciences &
Emerging Technologies — is the preclinical research leader in
critically important therapeutic fields such as interventional
cardiology, renal disease and dialysis, chronic drug-resistant
hypertension, women’s health, minimally invasive surgery,
orthopedics, biological and synthetic tissue repair, drug delivery,
bioresorbable devices, and combination medical device and
drug-eluting products. CBSET occupies a 35,000-square-foot,
state-of-the-art facility near Boston that includes a vivarium,
catheterization/imaging labs, surgical suites, dedicated labs for
SEM, histopathology/pathology, and drug metabolism and
pharmacokinetics. CBSET offers the latest equipment for
fluoroscopy, echocardiography (TEE/TTE), electrophysiology, IVUS,
optical coherence tomography (OCT), endoscopy/laparoscopy, surgical
video recording, histology, microradiography, and SEM (Scanning
Electron Microscopy).
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 in peripheral arteries 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, nearly 200,000 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
DisclosuresStealth 360® PAD Systems and
Diamondback 360® PAD Systems Indications: The
Stealth 360® PAD System and Diamondback 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.
Important Safety Information: 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, death,
dissection, perforation, distal embolization, thrombus formation,
hematuria, abrupt or acute vessel closure, or arterial spasm.
The Diamondback 360º Coronary Orbital Atherectomy
System
Indications: The Diamondback 360® Coronary Orbital
Atherectomy System (OAS) is a percutaneous orbital atherectomy
system indicated to facilitate stent delivery in patients with
coronary artery disease (CAD) who are acceptable candidates for
PTCA or stenting due to de novo, severely calcified coronary artery
lesions.
Contraindications: The OAS is contraindicated when the
ViperWire guide wire cannot pass across the coronary lesion or the
target lesion is within a bypass graft or stent. The OAS is
contraindicated when the patient is not an appropriate candidate
for bypass surgery, angioplasty, or atherectomy therapy, or has
angiographic evidence of thrombus, or has only one open vessel, or
has angiographic evidence of significant dissection at the
treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively
tortuous vessels or bifurcations may result in vessel damage; The
OAS was only evaluated in severely calcified lesions, A temporary
pacing lead may be necessary when treating lesions in the right
coronary and circumflex arteries; On-site surgical back-up should
be included as a clinical consideration; Use in patients with an
ejection fraction (EF) of less than 25% has not been evaluated. See
the instructions for use before performing Diamondback 360 Coronary
OAS procedures for detailed information regarding the procedure,
indications, contraindications, warnings, precautions, and
potential adverse events. For further information call CSI at
1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Federal law (USA) restricts these devices to sale by or on the
order of a physician.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150519007076/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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