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 full line of
OrbusNeich® JADE® percutaneous transluminal angioplasty (PTA)
over-the-wire (OTW) balloon catheters is now available in the
U.S.
CSI is the exclusive U.S. distributor of OrbusNeich balloon
products.
JADE is an OTW balloon catheter for PTA in the peripheral
vasculature, including obstructed native arteries and synthetic
arteriovenous dialysis fistulae, as well as for post-dilatation of
balloon expandable and self-expanding stents.
JADE is a non-compliant balloon designed for high pressure
tolerance and balloon dilatation with even pressure distribution
for the treatment of complex lesions. These balloons are compatible
with standard 0.014”, 0.018” and 0.035” guidewires, and with
catheter working lengths ranging from 135 cm to 200 cm and balloon
working lengths from 20 mm to 240 mm.
Dr. Kousta Issa Foteh, Vital Heart and Vein, Humble, Texas and
Dr. Siddhartha Rao, Vascular Solutions of North Carolina, Cary,
N.C., were two of the first physicians in the U.S. to adopt the
full line of JADE in their respective practices.
Said Dr. Foteh, “I was eager to add the full line of JADE PTA
balloons to my practice. The predictable, uniform inflation of
these non-compliant balloons allows for accuracy in balloon sizing
and reduces the potential for vessel recoil.”
Said Dr. Rao, “The deliverability of the JADE balloons, whether
it be on the 0.014”, 0.018” or 0.035” platform, is exceptional.
These balloons have consistently allowed me to cross and treat
challenging lesions successfully in situations where I would have
previously failed with other balloons.”
Scott R. Ward, CSI Chairman, President and Chief Executive
Officer, said, “We are excited to announce the full commercial
launch of the JADE balloons – an important addition to our
peripheral product offering. We believe we will drive meaningful
incremental revenue in our peripheral atherectomy cases by offering
a comprehensive portfolio of differentiated products designed to
save limbs and improve outcomes for patients undergoing complex
peripheral interventions.”
David Chien, OrbusNeich President and Chief Executive Officer,
said, “The launch of the JADE over-the-wire balloons in the U.S. is
a significant milestone for OrbusNeich that will allow us to
strengthen our presence in the U.S. alongside our existing
percutaneous transluminal coronary angioplasty and PTA portfolio.
We are confident that the OTW system will address many physicians’
needs and benefit patients.”
About Peripheral Artery Disease (PAD)
As many as 18 million Americans, most over age 65, suffer from
PAD, which is caused by the accumulation of plaque in peripheral
arteries reducing blood flow. Symptoms include leg pain when
walking or at rest. Left untreated, PAD can lead to severe pain,
immobility, non-healing wounds and eventually limb amputation. With
risk factors such as diabetes and obesity on the rise, the
prevalence of PAD is growing at double-digit rates.
Millions of patients with PAD may benefit from treatment with
orbital atherectomy utilizing the Stealth 360® and Diamondback 360®
Peripheral Orbital Atherectomy Systems, minimally invasive catheter
systems developed and manufactured by CSI. These systems use a
diamond-coated crown, attached to an orbiting shaft, which sands
away plaque while preserving healthy vessel tissue — a critical
factor in preventing reoccurrences. Balloon angioplasty and stents
have significant shortcomings in treating hard, calcified lesions.
Stents are prone to fractures and high recurrence rates, and
treatment of hard, calcified lesions often leads to vessel damage
and suboptimal results.
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 system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
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 are the COMBO® Plus Coronary Stent, together with stents
and balloons marketed under the names of AZULE®, SCOREFLEX®,
SCOREFLEX® NC, SAPPHIRE® II PRO, SAPPHIRE® 3, SAPPHIRE® II NC,
SAPPHIRE® NC Plus and SAPPHIRE® NC24 and the TELEPORT®
microcatheter, 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 the
benefits of JADE balloon catheters; the commercialization of JADE;
and CSI’s belief that it will drive meaningful incremental revenue
from a comprehensive portfolio of products, 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, the effectiveness of JADE balloon
catheters; 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.
Product Disclosure:
Indications: The JADE PTA Balloon Dilatation Catheter is
indicated for Percutaneous Transluminal Angioplasty in the
peripheral vasculature, including iliac, femoral, ilio-femoral,
popliteal, infra-popliteal, and renal arteries, and for the
treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. This device is also indicated for
post-dilation of balloon expandable and self-expanding stents in
the peripheral vasculature.
Contraindications: The use of the JADE PTA Balloon
Dilatation Catheter is contraindicated:
- for use in the coronary or neuro vasculature; and
- where there is the inability to cross the target lesion with a
guidewire.
Caution: Federal law (USA) restricts this device to sale
by, or on the order of, a physician.
The JADE PTA Balloon Dilation Catheters received FDA clearance
in 2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20210601005070/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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