[September 19, 2018] |
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Cardiovascular Systems, Inc. Announces First Commercial Launch of Peripheral Orbital Atherectomy System Outside the United States
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 patient in Hong
Kong has been treated with its Stealth 360® Peripheral
Orbital Atherectomy System (OAS). The Hong Kong case is the first
commercial use of Peripheral OAS outside of the United States.
Dr. Bryan Yan, Associate Professor, Chinese University of Hong Kong, who
treated the first patient in Hong Kong, said, "Patients with severely
calcified peripheral arteries can be difficult to treat due to the
limitations of traditional angioplasty or stenting. This can also place
patients at risk for subsequent complications including repeat
interventions and amputation. The commercialization of the Stealth 360®
OAS in Hong Kong provides physicians with a minimally invasive treatment
option for this complex patient population. I am very satisfied with the
procedural outcome for my patient because I was able to avoid implanting
a stent in the distal superficial femoral artery and I look forward to
continuing treatment of similar patients with this technology."
Said Scott Ward, Chairman, President and Chief Executive Officer of CSI,
"We are pleased that the first patient treated with OAS in conjunction
with our international distribution partner, OrbusNeich, was a success.
This positive outcome demonstrates our mutual mission to support
physicians in treating patients with peripheral artery disease."
Scott Addonizio, Senior Vice President and Chief Operating Officer of
OrbusNeich, concluded, "Our experienced sales force is thrilled to bring
CSI's orbital atherectomy technology to Hong Kong. This first procedure
occurred only two months after becoming CSI's international distribution
partner. We look forward to introducing CSI's atherectomy technology to
physicians in new markets in the months and years ahead."
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.
In January 2018, CSI announced that it was the exclusive U.S.
distributor for OrbusNeich® balloon products.
Ultimately, CSI will offer a full line of semi-compliant, non-compliant
and specialty balloons for both coronary and peripheral vascular
procedures. OrbusNeich® PCI (News - Alert) balloons include the
Sapphire® II Pro, the first and only 1.0mm coronary
balloon available in the United States.
In November 2016, CSI announced that Medikit, Co., Ltd. signed an
exclusive distribution agreementto sell its coronary and peripheral OAS
in 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 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. The Stealth 360® Peripheral
Orbital Atherectomy System (OAS) received CE Mark in October 2014. As of
June 30, 2018, over 392,000 of CSI's devices have been sold to leading
institutions across the United States and Japan.
About OrbusNeich OrbusNeich is a global pioneer in the
provision of 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; the
specific OrbusNeich products to be offered by CSI in the United States;
and the sale of CSI products in Japan, 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.
Product Disclosure The Diamondback 360® PAD
System is a percutaneous orbital atherectomy system indicated for use as
therapy in patients with occlusive atherosclerotic disease in peripheral
arteries and stenotic material from artificial arteriovenous dialysis
fistulae. The system is 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, distal embolization, thrombus formation,
hematuria, abrupt or acute vessel closure, or arterial spasm.
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/20180919005501/en/
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