ST. PAUL, Minn.--(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 Hong Kong has been treated with its Diamondback 360® Coronary Orbital Atherectomy System (OAS). This procedure marks the first international coronary procedure taking place as a result of the company’s distribution agreement with OrbusNeich®.
Dr. Michael Kang-Yin Lee, MBBS, FACC, FRCP, Director of Cardiac Catheterization Laboratory at the Division of Cardiology, Department of Medicine, Queen Elizabeth Hospital, Hong Kong, said, “Orbital Atherectomy is simple to use. It is a very controllable and predictable atherectomy device and is especially useful for diffuse and severely calcified coronary arteries, ensuring the angioplasty procedures can be completed with ease and good results. OAS also helps to fill the gap of the conventional devices when treating calcified coronary arteries.”
Scott Ward, Chairman, President and Chief Executive Officer of CSI, said, “We are thrilled to begin introducing our proven coronary atherectomy technology to physicians worldwide. As our international distribution partner, OrbusNeich, identifies new markets, we are prepared to provide best-in-class training to physicians committed to improving patient outcomes within this underserved patient population.”
Teddy Chien, Chairman Emeritus and Founder of OrbusNeich, added, “I was very pleased to have witnessed the first ever Coronary Orbital Atherectomy procedure performed in Hong Kong. CSI’s device supports our key business focus of providing solutions for all complex vascular interventions. We look forward to continuing global distribution of this clinically proven technology to our customers.”
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 balloons include the Sapphire® II Pro, the first and only 1.0mm coronary balloon available in the United States.
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 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 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 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, 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.