Cardiovascular Systems Files Special 510(k) for Stealth 360°™ Orbital Pad System
February 10 2011 - 4:40PM
Business Wire
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has filed a
Special 510(k) application with the U.S. Food and Drug
Administration (FDA). The application seeks marketing clearance for
the Stealth 360°™ Orbital PAD System, a third-generation electric
powered device for the treatment of peripheral arterial
disease.
“Development of our Stealth 360° device and this 510(k)
application are important milestones in CSI’s product development
roadmap,” said David L. Martin, president and CEO of Cardiovascular
Systems. “Greater ease of use and compelling data generated from
nearly 2,500 patients in our ongoing clinical trials are key to
establishing our unique technology for routine treatment of PAD
patients on a large scale, including the more than 250,000 PAD
patients who undergo surgery or amputations in the United States
each year.”
Martin continued, “CSI has an ongoing commitment to listening to
physicians’ feedback and responding with innovation. The Stealth
360° combines our Diamondback Predator 360° orbital mechanism of
action and crown design with new features to greatly reduce system
set-up times and put more control in the hands of physicians during
procedures. We believe these innovations will encourage more
physicians to adopt our technology to treat lesions from hip to
toe, including the most difficult occlusions below the knee to
restore outflow.”
The Stealth 360° system eliminates the large capital equipment
portion of the current product for a more compact system. With
simple, convenient speed adjustments on the handle, physicians can
use lower speeds and have greater control during the procedure to
achieve shorter spin times and a high percentage of plaque
reduction.
CSI expects to begin a limited market release of the Stealth
360° during the third quarter of fiscal 2011, pending FDA marketing
clearance.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a
medical device company focused on developing and commercializing
interventional treatment systems for vascular disease. The
company’s Diamondback 360® and Diamondback Predator 360°™ 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 can lead to tissue loss and
eventually 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.
For more information visit the company’s Web site at
www.csi360.com.
Product Disclosure
The Diamondback 360® PAD System and Diamondback Predator 360®
PAD System 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. The
Stealth 360° Orbital PAD System is currently under FDA review and
is not available for distribution in the United States.
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 release
of the Stealth 360° to the marketplace during the third quarter of
fiscal 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, FDA
clearances and approvals, 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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