Device offers a streamlined approach for lower
extremity embolic protection
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
the U.S. have been treated with the WIRION® Embolic Protection
WIRION is a distal embolic protection filter used to capture
thrombus and debris that can be associated with all types of
peripheral vascular intervention procedures, including atherectomy.
Physicians typically use embolic protection devices in vessels
located above the knee with long lesions, high plaque burden and
poor run off.
Dr. Lawrence Garcia, St. Elizabeth’s Medical Center, Boston,
Mass. and Dr. Nicolas Shammas, Unity Point Health-Trinity
Bettendorf, Davenport, Iowa participated in the WISE LE study where
WIRION demonstrated a major adverse event (MAE) rate of 1.9%, which
is lower than previously reported rates for other lower extremity
embolic protection filters. Importantly, no clinically significant
distal embolization was observed when WIRION was used.
Said Dr. Garcia, “WIRION represents a critical advancement for
distal embolic protection devices. With WIRION, I can use my
preferred 0.014” guidewire to cross the lesion and then place the
filter anywhere on the wire. As a result, I am able to provide
extensive support, individualized to each patient and
Said Dr. Shammas, “Delivery and retrieval of WIRION are easy
with a minimal learning curve. Debris capture is very efficient
making WIRION exceptionally suited for use with any atherectomy
Scott R. Ward, CSI Chairman, President and Chief Executive
Officer, said, “We are excited to announce the commercialization of
WIRION. This product will be an important part of our comprehensive
portfolio of differentiated products designed to save limbs and
improve outcomes for patients undergoing complex peripheral
About WISE LE
WISE LE (WIRION EPS in Lower Extremities Arteries) was a
multicenter study, performed in the United States and Germany and
included all commercially-available atherectomy systems. The
primary endpoint was freedom from major adverse events (MAEs)
occurring within 30 days post-procedure and was compared with an
objective performance goal derived from historical atherectomy
trials. MAE was defined as a serious adverse event that resulted in
death, acute myocardial infarction, thrombosis, pseudoaneurysm,
dissection (grade C or greater), or clinical perforation at the
filter location, clinically relevant distal embolism, unplanned
amputation, or clinically driven target vessel
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
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 WIRION system; the commercialization of the WIRION
system; and CSI’s 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 the WIRION system; 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.
Indications: WIRION is indicated for use as an embolic
protection system to contain and remove embolic material
(thrombus/debris) while performing atherectomy in calcified lesions
of the lower extremities. The diameter of the vessel at the site of
filter basket placement should be between 3.5mm to 6.0mm. WIRION
may be used with commercially available 0.014" guide wires.
Contraindications: The system is contraindicated for
patients with severe allergy to Heparin, patients with uncorrected
bleeding disorder, and patients in whom anticoagulant and
antiplatelet therapy is contraindicated.
Caution: Federal law (USA) restricts this device to sale
by, or on the order of, a physician.
The WIRION® Embolic Protection System received FDA clearance and
CE Mark approval in March 2021.
version on businesswire.com: https://www.businesswire.com/news/home/20210317005169/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919