[January 16, 2019] |
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First Patients in the Middle East Treated with Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System
Cardiovascular Systems, Inc. (CSI (News - Alert)®) (NASDAQ: CSII), a
medical device company developing and commercializing innovative
interventional treatment systems for patients with peripheral and
coronary artery disease, announced today that the first patients in the
United Arab Emirates (UAE) have been treated with its Diamondback 360®
Coronary Orbital Atherectomy System (OAS).
The first UAE patients were treated by Professor Aref Nooryani, Chief
Executive Officer and Head of the Al Qassimi Hospital Cardiac Center,
Sharjah, UAE.
Professor Nooryani said, "Patients with calcific coronary artery disease
have poor clinical outcomes. Until today, these patients presented a
difficult challenge due to the limitations of the other therapies
available to me. CSI's unique orbital atherectomy technology enables
effective modification of calcified lesions. The availability of the
Diamondback 360® OAS in the UAE provides
physicians, like me, with a minimally-invasive treatment option for a
complex patient population."
Scott Ward, Chairman, President and Chief Executive Officer of CSI,
said, "In six months since we announced our international distribution
partnership with OrbusNeich, we have successfully introduced OAS
technology in Asia, Europe and the Middle East. Together we are
demonstrating that the combination of OrbusNeich's large international
sales channel supported by CSI's physician training and education will
allow us to treat an increasing number of patients suffering from
peripheral and coronary artery disease."
In July 2018, CSI announced that it had signed an exclusive
international distribution agreement with OrbusNeich to sell its
coronary and peripheral OAS outside of the United States and Japan.
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 OAS 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. The Stealth 360® Peripheral
Orbital Atherectomy System (OAS) received CE Mark in October 2014. Over
400,000 of CSI's devices have been sold to leading institutions
worldwide.
About OrbusNeich OrbusNeich® is a global
pioneer in the provision f life-changing vascular solutions and offers
an extensive portfolio of products that set industry benchmarks in
vascular intervention. Current products include the world's first dual
therapy stents, the COMBO® Plus and COMBO® Dual
Therapy Stents, together with stents and balloons marketed under the
names of Azule®, Scoreflex®, Sapphire®
II, Sapphire® II PRO and Sapphire®
II NC, as well as products to treat peripheral artery disease: the Jade®
and Scoreflex® PTA balloons. OrbusNeich is
headquartered in Hong Kong and has operations in Shenzhen, China; Fort
Lauderdale, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan.
OrbusNeich supplies medical devices to physicians in more than 60
countries. For more information, visit www.OrbusNeich.com.
Safe Harbor Certain statements in this news release are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and are provided under the protection of
the safe harbor for forward-looking statements provided by that Act. For
example, statements in this press release regarding anticipated future
introduction of CSI devices outside of the United States and Japan; and
the opportunity relating to these international sales, are
forward-looking statements. These statements involve risks and
uncertainties that could cause results to differ materially from those
projected, including, but not limited to, regulatory developments,
clearances and approvals; approval of our products for distribution in
countries outside of the United States; approval of our products for
reimbursement in and the level of reimbursement; the ability of
OrbusNeich to successfully launch CSI products outside of the United
States and Japan; the experience of physicians regarding the
effectiveness and reliability of CSI's products; the reluctance of
physicians, hospitals and other organizations to accept new products;
the impact of competitive products and pricing; general economic
conditions; international trade developments; and other factors detailed
from time to time in CSI's SEC (News - Alert) reports, including its most recent annual
report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI
encourages you to consider all of these risks, uncertainties and other
factors carefully in evaluating the forward-looking statements contained
in this release. As a result of these matters, changes in facts,
assumptions not being realized or other circumstances, CSI's actual
results may differ materially from the expected results discussed in the
forward-looking statements contained in this release. The
forward-looking statements made in this release are made only as of the
date of this release, and CSI undertakes no obligation to update them to
reflect subsequent events or circumstances.
Diamondback 360® Coronary Orbital
Atherectomy Systems Indications: The Diamondback
360 Coronary Orbital Atherectomy Systems (OAS) are percutaneous orbital
atherectomy systems 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 are 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 are 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.
Caution: Federal law (USA) restricts this device to sale by
or on the order of a physician.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190116005779/en/
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