Cardiovascular Systems, Inc. Announces Acquisition of Peripheral Support Catheters From WavePoint Medical, LLC
March 22 2021 - 9:00AM
Business Wire
Agreement also includes development of
portfolio of CTO products
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) announced
today that it has acquired a line of peripheral support catheters
from WavePoint Medical, LLC.
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. CSI anticipates it will introduce the
acquired catheters as its new ViperCross™ line in the first half of
its fiscal year ending June 30, 2022.
In addition, as part of this transaction, WavePoint will also
develop a portfolio of specialty catheters used in the treatment of
chronic total occlusions (CTO) and complex percutaneous coronary
intervention (PCI) procedures for CSI. CTOs represent a significant
and growing segment of PCIs and often contribute to poor patient
outcomes. Commercial availability of these specialty catheters is
anticipated in CSI’s fiscal year ending June 30, 2023.
Scott R. Ward, Chairman, President and Chief Executive Officer
of CSI, said, “With the acquisition of these peripheral support
catheters, CSI will soon offer a complete portfolio of products for
the treatment of peripheral artery disease, including atherectomy,
balloon catheters, guidewires, support catheters and embolic
protection. In coronary, the successful development of a portfolio
of CTO products will expand our existing offering of coronary
support products. Together, these new products advance our ability
to help physicians improve outcomes for patients undergoing complex
peripheral and coronary interventions.”
About WavePoint Medical, LLC
WavePoint Medical LLC, a MedVenture Holdings portfolio company,
is a Utah based medical device development company focused on
high-performance micro-catheters for the interventional
cardiovascular markets. MedVenture Holdings partners with
entrepreneurs, physicians, and management teams to advance
healthcare products, services, and technologies that improve human
health and wellness. For additional information, please visit
www.medventureholdings.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 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 Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death
in men and women globally. CAD occurs when a fatty material called
plaque builds up on the walls of arteries that supply blood to the
heart. The plaque buildup causes the arteries to harden and narrow
(atherosclerosis), reducing blood flow. The risk of CAD increases
if a person has one or more of the following: high blood pressure,
abnormal cholesterol levels, diabetes, or family history of early
heart disease. According to the American Heart Association, 16.3
million people in the United States have been diagnosed with CAD,
the most common form of heart disease. Heart disease claims more
than 600,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in nearly 30
percent of patients undergoing a PCI. Significant calcium
contributes to poor stent delivery, expansion and wall apposition
leading to poor outcomes and higher treatment costs in coronary
interventions when traditional therapies are used, including a
significantly higher occurrence of death and major adverse cardiac
events (MACE).
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 the acquired catheters, including the
anticipated timing thereof; the development and commercial
introduction of the specialty catheters, including the anticipated
timing thereof; and the impact to CSI of these new 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 ability of
WavePoint to meet development milestones; technical challenges;
regulatory developments and approvals; 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 is a registered trademark of Cardiovascular Systems, Inc.
All other trademarks cited herein are owned by their respective
owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20210322005010/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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