First Patient in Hong Kong Treated with Cardiovascular Systems, Inc. Coronary Orbital Atherectomy System
November 08 2018 - 7:00AM
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 OrbusNeichOrbusNeich 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 HarborCertain 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 DisclosureThe 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181108005088/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaMatt Sullivan,
612-455-1709matt.sullivan@padillaco.com
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