First Patient in Europe Treated With Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System
February 08 2021 - 4:05PM
Business Wire
Cardiovascular Systems, Inc. (CSI®) (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 patient in
Europe has been treated with its Diamondback 360® Coronary Orbital
Atherectomy System (OAS).
Professor Nicolas Van Mieghem, Director of Interventional
Cardiology, Thoraxcenter, Erasmus University Medical Center,
Rotterdam, The Netherlands, who successfully treated the first
European patient, said, “Patients with calcific coronary artery
disease have poor clinical results. Diamondback 360® Coronary OAS
streamlines treatment with a unique mechanism to successfully
modify severe calcium and optimize stent performance. I’m confident
European physicians will like this fascinating technology to help
treat their patients with calcific coronary artery disease.”
Orbital atherectomy has demonstrated clinical advantages
compared to historical rotational atherectomy data, including lower
rates of target lesion revascularization and persistent slow
flow/no reflow. CSI’s ORBIT II and COAST clinical studies
demonstrated that OAS is safe and effective in treating patients
with de novo severely calcified coronary lesions. Two real-world
studies with approximately 1000 patients have reinforced
Diamondback’s safety, high procedural success and long term
clinical success.
CSI received CE Mark for the Diamondback 360® Coronary OAS in
January 2021. Diamondback is FDA approved and has been sold in the
United States since 2013.
Scott Ward, Chairman, President and Chief Executive Officer of
CSI, said, “We are excited to announce the first commercial use of
the Diamondback 360® Coronary OAS in Europe. The introduction of
this device gives physicians in Europe an effective treatment
option for this difficult-to-treat patient population. We are
prepared to launch the product leveraging streaming platforms to
train and support physicians and their cath lab teams remotely
until travel may resume.”
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 system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
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 the
commercial launch of the Diamondback 360® Coronary OAS in Europe
(including the timing, scope and methods thereof), and the benefits
of this product, 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, the
reluctance of physicians, hospitals and other organizations to
accept new products; the effectiveness of these products; the
efforts of us and our distribution partners in launching this
product; the impact of competitive products and pricing; approval
of products for reimbursement and the level of reimbursement;
general economic conditions; international trade developments; the
ongoing COVID-19 pandemic and the impact and scope thereof on CSI,
our distribution partners, the supply chain, and physicians and
facilities in Europe, including government actions related to the
COVID-19 outbreak, material delays and cancellations of procedures,
delayed spending by healthcare providers, and distributor and
supply chain disruptions; and other factors detailed from time to
time in CSI’s SEC 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.
U.S. Diamondback 360® 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 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 these devices to
sale by or on the order of a physician.
The Diamondback 360® Coronary OAS is FDA PMA approved.
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version on businesswire.com: https://www.businesswire.com/news/home/20210208005535/en/
Cardiovascular Systems, Inc. Jack Nielsen (651) 202-4919
j.nielsen@csi360.com
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