Cardiovascular Systems, Inc. (CSI) (Nasdaq:CSII) has received
510(k) marketing clearance from the U.S. Food and Drug
Administration (FDA), and has begun a limited market release for
the Stealth 360°™ Orbital PAD System. The Stealth 360° propels CSI
into the forefront of treating peripheral arterial disease (PAD)
with a simpler design that gives physicians complete control of
device operation. Additionally, the new system utilizes CSI’s
proven orbital mechanism of action that protects healthy tissue
while removing even the most difficult to treat plaque.
Cardiovascular Systems, Inc., has
received FDA 510(k) marketing clearance for the Stealth 360°(TM)
Orbital PAD System. This advanced, electric-powered device for
treating peripheral arterial disease (PAD) gives physicians greater
control during treatment and shorter procedure times. A compact,
portable saline infusion pump fits onto a standard IV pole for easy
transport, set-up and storage - reducing lab staff time. (Photo:
Business Wire)
“The new Stealth 360° is as fast and easy to set up as a balloon
or stent, but safer and more durable,” said Dr. J. Mustapha, an
interventional cardiologist at Metro Health Hospital in Grand
Rapids, Mich., who treated the first patient with the Stealth 360°.
“This device provides effective treatment for the entire leg,
including small calcified vessels below the knee that are critical
to achieving blood flow to the foot.”
Dr. Raymond Dattillo, an interventional cardiologist at St.
Francis Medical Center, Topeka, Kan., added, “The Stealth 360° puts
the controls at my fingertips, giving me better tactile feel and
allowing me to operate the device independently. The easier setup,
along with the demonstrated safety and effectiveness of CSI’s
orbital devices, positions this as an essential tool for treatment
of PAD.”
The Stealth 360°’s advanced, electric-powered handle features a
power on/off button and speed selection controls conveniently
positioned for ease of use and greater physician control. By
eliminating the compressed air tank and separate speed controller
of previous CSI systems, the Stealth 360° significantly reduces
device set-up and lab staff time.
The Stealth 360° incorporates the Diamondback Predator 360°
orbital mechanism of action, optimal shaft and crown
configurations. Preliminary results in nearly 800 lesions from
CSI’s Confirm II Predator study demonstrate that the crown is
designed for maximal plaque removal at lower speeds in the shortest
amount of time. The shaft is flexible and suited for compromised
run-off, vessel bends or tortuous anatomy.
“With the Stealth 360°, physicians have a clinically proven,
easy-to-use, front-line treatment for routine and complex cases,”
said David L. Martin, CSI president and chief executive officer.
“Continued innovation, with our growing wealth of clinical data,
will drive broad adoption and help physicians achieve a new and
fantastic standard of care for the PAD patient.”
CSI’s limited market release will generate valuable feedback
from physicians to establish best practices for device operation
and provide a smooth transition to the new platform. Given the
timing of FDA clearance and limited nature of the market release,
significant revenue from the new product is not expected until
CSI’s fourth quarter, ending June 30, 2011.
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 disease. The company’s
Diamondback 360®, Diamondback Predator 360°™ and Stealth 360°
Orbital PAD Systems treat calcified and fibrotic plaque in arterial
vessels throughout the leg in a few minutes of treatment time, and
address many of the limitations associated with existing surgical,
catheter and pharmacological treatment alternatives. As many as 12
million Americans suffer from peripheral arterial disease (PAD),
which is caused by the accumulation of plaque in peripheral
arteries (commonly the pelvis or leg) reducing blood flow. Symptoms
include leg pain when walking or at rest, and tissue loss that can
lead to limb amputation. In August 2007, the U.S. FDA granted
510(k) clearance for the use of the Diamondback 360° as a therapy
for PAD, and CSI commenced a U.S. product launch in September 2007.
Since then, over 37,000 procedures have been performed using the
Diamondback 360° in leading institutions across the United States.
CSI also has commenced its ORBIT II Investigational Device
Exemption clinical trial to evaluate the safety and effectiveness
of its Diamondback 360° System in treating coronary arteries.
For more information visit the company’s Web site at
www.csi360.com.
Product Disclosure
The Diamondback 360®, Diamondback Predator 360® and Stealth
360°™ Orbital PAD Systems are percutaneous orbital atherectomy
systems indicated for use as therapy in patients with occlusive
atherosclerotic disease in peripheral arteries and stenotic
material from artificial arteriovenous dialysis fistulae. The
systems are contraindicated for use in coronary arteries, bypass
grafts, stents or where thrombus or dissections are present.
Although the incidence of adverse events is rare, potential events
that can occur with atherectomy include: pain, hypotension,
CVA/TIA, death, dissection, perforation, distal embolization,
thrombus formation, hematuria, abrupt or acute vessel closure, or
arterial spasm.
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 our expectation that the innovations of the Stealth 360°,
with our growing wealth of clinical data, will drive broad adoption
of our technology by physicians and make it an integral part of
their approach to treating PAD; the effect of our limited market
release of the Stealth 360°; and our expectation that significant
revenue from the new product is not expected until our fourth
quarter, ending June 30, 2011, are forward-looking statements.
These statements involve risks and uncertainties which could cause
results to differ materially from those projected, including, but
not limited to, physician acceptance of the Stealth 360°, the
impact of competitive products and pricing, the effectiveness of
the Stealth 360°, 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.
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