First Patients in Europe Treated with Cardiovascular Systems, Inc. Peripheral Orbital Atherectomy System
November 13 2018 - 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 patients in
Germany have been treated with its Stealth 360® Peripheral Orbital
Atherectomy System (OAS). The German cases represent the first
commercial use of Peripheral OAS in Europe.
Dr. Tobias Achenbach, head of the Radiology Department at the
St. Vincenz Hospital, K�ln, where the first patients in Germany
were treated by his colleagues Dr. Reza Asady and Dr. Ingo
Benz, said, “CSI’s minimally invasive orbital atherectomy
technology allows physicians to gently modify calcified plaque and
enables peripheral revascularization for patients with severely
calcified arteries. The introduction of orbital atherectomy in
Germany greatly improves the treatment options for my patients
suffering from peripheral artery disease, or PAD.”
Prof. Dierk Scheinert, Head of the Department of Medicine,
Angiology and Cardiology, Park-Krankenhaus Leipzig, and Head
Department of Angiology, University Hospital Leipzig Heart Center,
Leipzig, Germany said, “Of those suffering from PAD, many progress
to critical limb ischemia, or CLI, the most severe and potentially
deadly form of PAD. If left untreated, CLI can lead to amputation.
The unique ability of orbital atherectomy to safely treat calcified
peripheral lesions, both above and below the knee, will allow
physicians in Germany to help a very challenging patient
population.”
Scott Ward, Chairman, President and Chief Executive Officer of
CSI, said, “By leveraging our international distribution partner,
OrbusNeich, we are demonstrating our ability to rapidly introduce
our OAS technology to physicians worldwide. We look forward to
training many more physicians that share our passion for improving
the outcomes of patients suffering from peripheral and coronary
artery disease.”
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.
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; 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 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/20181113006079/en/
Cardiovascular Systems, Inc.Jack Nielsen(651)
202-4919j.nielsen@csi360.com
Padilla:Matt Sullivan(612)
455-1709matt.sullivan@padillaco.com
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