Cardiovascular Systems, Inc. Announces Full Market Release of the 2.00 Max Crown for Peripheral Orbital Atherectomy Systems
17 Octobre 2022 - 1:00PM
Business Wire
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 the full market release of
the 2.00 Max Crown for Peripheral Orbital Atherectomy Systems (2.00
Max Crown).
Built on the proven Diamondback 360® Orbital Atherectomy
platform, the 2.00 Max Crown is uniquely designed to enable
simultaneous modification of both intimal and medial calcium. The
new 2.00 Max Crown features an increased 70-micron diamond coated
crown that creates more efficient engagement in mixed plaque,
helping to achieve optimal luminal gain in mild to moderately
calcified lesions above the knee.
Dr. Amit Srivastava, MD, FACC, FABVM at Bay Area Heart Center in
St. Petersburg, Fla., was one of the first physicians in the U.S.
to incorporate the 2.00 Max Crown into his practice.
Said Dr. Srivastava, “The new 2.00 Max Crown greatly expands the
lesions that can be treated with CSI’s Orbital Atherectomy. This
device delivers exceptional luminal gain in mixed morphology
lesions above the knee.”
Scott R. Ward, Chairman, President and Chief Executive Officer
of CSI, said, “The full commercial launch of the 2.00 Max Crown
represents another important product launch for CSI as we broaden
and diversify our product offering. Our peripheral orbital
atherectomy systems can now treat a wider range of plaque
morphologies throughout the leg. Combining this new device with our
full line of interventional support devices, we continue to advance
the ability of physicians to improve outcomes for patients
undergoing peripheral interventions.”
About Peripheral Artery Disease (PAD) Eighteen to 20
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.
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 more information, visit
www.csi360.com and follow us on LinkedIn and Twitter.
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 2.00 Max Crown, the impact
of this new product, and the broadening and diversification of
CSI’s product offering, 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 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® and Diamondback 360® are trademarks of Cardiovascular
Systems, Inc.
Product Disclosure: The Diamondback 360® Peripheral
Orbital Atherectomy System Exchangeable Series, which includes the
Max*, Solid, Classic and Micro crowns, is a percutaneous orbital
atherectomy system indicated for use as therapy in patients with
occlusive atherosclerotic disease in peripheral arteries and
stenotic material from artificial arteriovenous dialysis fistulae.
Contraindications for the system include 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 2.00 Max Crown has not been tested to support removal of
stenotic material from artificial arteriovenous dialysis fistulae
(AV shunt).
See the instructions for use for detailed information regarding
the procedure, indications, contraindications, warnings,
precautions, and potential adverse events. For further information
call CSI at 1-877-274-0901 and/or consult CSI’s website at
www.csi360.com.
Caution: Federal law (USA) restricts these devices to sale by or
on the order of a physician.
The 2.00 Max Crown received FDA 510(k) clearance.
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version on businesswire.com: https://www.businesswire.com/news/home/20221017005007/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
Cardiovascular Systems (NASDAQ:CSII)
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