Cardiovascular Systems Launches Diamondback Predator 360°™ PAD System
August 03 2010 - 8:00AM
Business Wire
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has launched
its second-generation product, the Diamondback Predator 360°™ PAD
System, for the treatment of peripheral arterial disease (PAD). The
new device uses the same mechanism of action as the clinically
proven Diamondback 360® PAD System with improvements in the crowns
and shaft for enhanced clinical performance and shorter procedure
times. CSI received Food and Drug Administration special 510(k)
marketing clearance for the Diamondback Predator 360°, and the
company has completed an extensive limited market release with
approximately 1,500 patients treated. The product is now available
for broad commercialization.
The Diamondback Predator 360°, a minimally invasive catheter
system, offers physicians a first-line therapy to quickly change
lesion compliance, facilitate low-pressure balloon inflation, if
desired, and achieve a smooth vessel lumen without placing a stent.
With the Diamondback Predator 360°, physicians can now treat PAD
more efficiently, achieving shorter procedure times and greater
plaque reduction to address complex lesions located anywhere
between the hip and toes. Both CSI PAD systems include a
diamond-coated crown and unique orbital mechanism of action to
remove hardened plaque to restore blood flow in arteries throughout
the leg. The core technology of these systems is designed to avoid
damage to blood vessels to possibly delay restenosis and foster
better long-term patient outcomes.
“Cardiovascular Systems’ PAD solutions are highly effective in
removing plaque from arteries, and the Diamondback Predator 360°
enhances the treatment process,” said Dr. Prakash Makam, medical
director of clinical research at Community Hospital in Munster,
Ind. “The ability to use lower speeds reduces the risk of
complications during the procedure while removing a high percentage
of plaque to achieve excellent acute outcomes in less time.”
CSI has also initiated the CONFIRM PREDATOR registry, a
prospective, multi-center study which will follow 500 PAD patients
treated with the Diamondback Predator 360°. The new registry will
collect information on Diamondback Predator 360° performance,
including: overall plaque reduction, key acute safety measures and
techniques for optimal outcomes.
“The introduction of the Diamondback Predator 360° underscores
our commitment to listen to physicians’ feedback and respond with
superior tools to treat PAD,” said David L. Martin, president and
chief executive officer of Cardiovascular Systems. “We are
dedicated to evidence-based medicine, and our prospective studies,
well over 1,000 patients strong, are informing decisions made by
patients and their families, physicians and payers. Physicians who
have used the Diamondback Predator 360° have found the enhanced
system gives them reliable, safe performance and favorable
outcomes.”
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 intended to enjoy the protection of the
safe harbor for forward-looking statements provided by that Act.
For example, statements in this press release regarding the CONFIRM
PREDATOR registry 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 the
potential for unanticipated delays in enrolling medical centers and
patients for studies; new data or events that may disrupt plans for
these studies; unexpected results or clinical outcomes in our
trials, and other factors detailed from time to time in CSI’s SEC
reports, including its most recent annual report on Form 10-K. 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.
About Cardiovascular Systems, Inc.
Cardiovascular Systems Inc., (CSI) (Nasdaq: CSII) based in St.
Paul, Minn., is a medical device company focused on providing
clinically proven, safe and effective interventional solutions for
vascular disease. The company’s Diamondback 360® PAD System removes
calcified and fibrotic plaque in small and large peripheral
vessels, and addresses many of the limitations associated with
existing surgical, catheter and pharmacological treatment
alternatives. In August 2007, the U.S. FDA granted 510(k) clearance
for the use of the Diamondback 360° as a therapy for PAD
(peripheral arterial disease), and CSI commenced a U.S. product
launch in September 2007. Since then, more than 25,000 procedures
have been performed using the system. In July 2010, the company
launched the Diamondback Predator 360° PAD System, its
second-generation product with upgrades to crowns and the shaft,
providing physicians greater ease of use and shorter procedure
times. For more information visit the company’s website 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 system is
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.
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