Introduction of Orbital Atherectomy in
Canada Expands Treatment Options for Patients with Complex Coronary
Artery Disease
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 patients in
Canada have been treated with its Diamondback 360® Coronary Orbital
Atherectomy System (OAS).
The first patients in Canada were treated by Sanjog Kalra, MD,
Interventional Cardiologist and Cardiac Critical Care Physician at
the Peter Munk Cardiac Centre, Toronto General Hospital, part of
the University Health Network.
Dr. Kalra said, “Patients with calcific coronary artery disease
can have poor clinical outcomes unless optimally treated.
Revascularization for these patients requires interventionalists to
fully prepare vessels for stenting so that full stent expansion is
achieved. We know that perfect stent results lead to the best
outcomes.
“Achieving optimal vessel preparation in heavily calcified
coronary arteries is amongst my most challenging procedures. CSI’s
orbital atherectomy technology enables effective calcium
modification to facilitate full stent expansion. In addition, OAS
is optimized for efficiency as it allows bi-directional atherectomy
in multiple vessel sizes with one device.”
Diamondback combines sanding and pulsatile force to treat a
broad range of calcium morphology and lesion types. Orbital
atherectomy has demonstrated clinical advantages compared to
alternative treatments, including low- rates of procedural
complications and target lesion revascularization through 3-years.
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
and high procedural success.
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 Canada. The introduction of
this device gives physicians in Canada an effective treatment
option for this difficult-to-treat patient population.”
About Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death
in men and women globally. 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 Centers for Disease Control and
Prevention, 18.2 million people in the United States have CAD, the
most common form of heart disease. Heart disease claims more than
650,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in about 30
percent of patients undergoing a PCI. Significant calcium
contributes to poor stent delivery, expansion and wall apposition
leading 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 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 Canada
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 Canada, 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.
Diamondback 360® Coronary Orbital Atherectomy Systems
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 and CE
Marked.
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version on businesswire.com: https://www.businesswire.com/news/home/20210830005508/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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