Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.
March 01 2018 - 2:31PM
Business Wire
Device is the smallest, 510(k) cleared
coronary balloon in the U.S. market
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, today announced that the U.S. Food and
Drug Administration (FDA) has granted 510(k) clearance for the
OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.
OrbusNeich’s 1.0mm Sapphire II PRO, the first and only 1.0mm
coronary balloon available in the U.S., offers industry-leading
entry and crossing profiles and is precision engineered for
crossing and treating extremely tight and complex lesions.
In January, CSI announced it is the exclusive U.S. distributor
of OrbusNeich balloon products. OrbusNeich is a globally recognized
corporation with established balloon technologies in both
percutaneous coronary intervention (PCI) and percutaneous
transluminal angioplasty (PTA).
“As physicians, we have continued to advance techniques and
expand access to interventional cardiology procedures. As a
result, the patients we are treating today have become increasingly
complex, with more challenging lesions and anatomy, and with more
difficult clinical indications,” according to David E. Kandzari,
M.D., Director of Interventional Cardiology and Chief Scientific
Officer, Piedmont Heart Institute, Atlanta, GA, and principal
investigator for the Sapphire II PRO U.S. Clinical Study. “With its
exceptionally low profile and deliverability, the Sapphire II PRO
is an important new tool to enable us to better treat the patients
we serve.”
Scott Ward, CSI’s Chairman, President and Chief Executive
Officer, said, “Offering the Sapphire II PRO 1.0mm coronary
balloon—the smallest, FDA-cleared coronary balloon on the market—is
critical for physicians treating highly complex coronary lesions.
As the market leader in coronary atherectomy, the 1.0mm balloon
complements our orbital atherectomy system as we continue providing
advanced solutions for treating the complex and high-risk indicated
patient.”
At launch, CSI will offer both the 1.0-4.0mm Sapphire II PRO and
the 2.0-4.0mm Sapphire® NC Plus non-compliant coronary balloons on
a limited basis. The company anticipates that OrbusNeich’s full
balloon product portfolio will become available in the U.S.
throughout 2018 and 2019.
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.
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 the
first 510(k) clearance for the use of the Orbital Atherectomy
System in peripheral arteries in August 2007. In October 2013, the
company received FDA approval for the Coronary Orbital Atherectomy
System. To date, over 356,000 of CSI’s devices have been sold to
leading institutions across the United States. For more
information, visit the company’s website at www.csi360.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 the
benefits of the 1.0mm balloon and the commercial launch of
OrbusNeich’s balloon portfolio in the U.S., including the
anticipated timing thereof, 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, agreements with third parties to sell their products;
the experience of physicians regarding the effectiveness and
reliability of products sold by CSI; the reluctance of physicians,
hospitals and other organizations to accept new products; the
impact of competitive products and pricing; 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.
US Indications for Use
The Sapphire® II PRO Coronary Dilatation Catheter (1.0-1.25mm
configurations) is indicated for:
- Balloon pre-dilatation of a stenotic
portion of a coronary artery or bypass graft stenosis (≥70%
stenosis) for the purposes of improving myocardial perfusion
The Sapphire® II PRO Coronary Dilatation Catheter (1.5-4.0mm
configurations) is indicated for:
- Balloon dilatation of the stenotic
portion of a coronary artery or bypass graft stenosis in patients
evidencing coronary ischemia for the purpose of improving
myocardial perfusion
- Balloon dilatation of a coronary artery
occlusion for the treatment of acute myocardial infarction
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version on businesswire.com: http://www.businesswire.com/news/home/20180301006392/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaMatt Sullivan,
612-455-1709matt.sullivan@padillaco.com
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