Cardiovascular Systems, Inc. Announces First Patient Treated with ViperCross™ Peripheral Support Catheter
September 29 2021 - 4:40PM
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 has
been successfully treated with its ViperCross peripheral support
catheter.
Dr. Billy J. Kim, MD, The Surgical Clinic, Nashville, Tenn.,
treated the first patient with ViperCross.
Said Dr. Kim, “ViperCross offers the right balance of support
and flexibility to successfully navigate tortuous anatomy and cross
challenging lesions. In addition, ViperCross provides excellent
guidewire support and facilitates easy guidewire exchange.”
Peripheral support catheters are used during peripheral vascular
intervention (PVI) procedures for guidewire support to enable
lesion crossing, as well as for guidewire exchanges. Physicians use
support catheters in approximately 50% of PVIs, primarily in
below-the-knee and complex interventions. When calcium is present,
lesions can be challenging to cross with an interventional
guidewire and often require advanced tools prior to vessel
preparation and treatment.
Scott R. Ward, Chairman, President and Chief Executive Officer
of CSI, said, “With the commercial launch of ViperCross, CSI now
offers a complete portfolio of products for the treatment of
peripheral artery disease, including atherectomy, balloon
catheters, guidewires, support catheters and embolic protection.
Combined, these products advance our ability to help physicians
improve outcomes for patients undergoing complex peripheral
interventions.”
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 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.
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
commercial introduction of ViperCross and the impact of this new
product 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
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; general economic
conditions; 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.
CSI®, Diamondback 360®, Stealth 360® and ViperCross™ are
trademarks of Cardiovascular Systems, Inc.
Product Disclosure:
Indications: The 018/035 ViperCross support catheters are
intended to be used in conjunction with steerable guidewires to
access discrete regions of the peripheral vasculature. The 014
ViperCross support catheters are intended to be used to access
discrete regions of the peripheral and/or coronary vasculature.
ViperCross catheters may be used to facilitate placement and
exchange of guidewires and other interventional devices and to
sub-selectively infuse/deliver diagnostic and therapeutic
agents.
See the instructions for use for detailed information regarding
the procedure, indications, contraindications, warnings,
precautions, and potential adverse events. For further information
call CSI at 1-877-274-0901 and/or consult CSI’s website at
www.csi360.com.
Caution: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
The ViperCross received FDA 510(k) clearance.
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version on businesswire.com: https://www.businesswire.com/news/home/20210929005954/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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