FDA Clears Next-Generation Guide Wire for Cardiovascular Systems' Peripheral Orbital Atherectomy Systems
July 06 2015 - 5:00PM
Business Wire
ViperWire Advance Peripheral Guide Wire with
Flex Tip Offers Greater Flexibility and Navigation; Improves
Systems’ Ease-of-Use When Treating Calcified Lesions in Torturous
Arterial Anatomy
Cardiovascular Systems, Inc. (NASDAQ:CSII) (CSI), today
announced that it has received FDA clearance for its new ViperWire
Advance® Peripheral Guide Wire with Flex Tip for their Peripheral
Orbital Atherectomy Systems (OAS). The new guide wire provides
physicians with improved flexibility, navigation and
ease-of-use—particularly in hard-to-reach, tortuous vessels—when
treating arterial calcium associated with peripheral artery disease
(PAD).
Building on the success of the current ViperWire Advance, this
next-generation wire offers a reduction in tip stiffness, with
comparable torque transfer, making it easier for physicians to
navigate vasculature. The guide wire also provides improved
trackability through tortuous peripheral arteries.
Additional features and enhancements of the ViperWire Advance
Guide Wire with Flex Tip include:
- A Nitinol support coil, for a more
durable tip and the ability to be reshaped for multiple uses;
and
- Larger proximal core, for improved kink
resistance and more delivery support for adjunctive devices.
“We designed the ViperWire Advance with Flex Tip to improve
ease-of-use for our peripheral orbital atherectomy systems when
treating complex calcified lesions,” said David L. Martin, CSI
president and chief executive officer. “By improving the
predictability and deliverability of the guide wire, physicians
will now have more confidence in their ability to navigate tortuous
peripheral anatomy and address PAD in a traditionally
difficult-to-treat patient population.”
CSI anticipates launching ViperWire Advance with Flex Tip in
early August 2015. The guide wire is for use with CSI’s 145 cm
Stealth 360® and Diamondback 360® Peripheral OAS.
About Peripheral Arterial Disease (PAD)As many as 18
million Americans, most over age 65, suffer from PAD, which is
caused by plaque accumulation in peripheral arteries (commonly the
pelvis or leg) 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 continues to grow.
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 in
calcified lesions, and treatment of hard, calcified lesions often
leads to vessel damage and suboptimal results.
Product DisclosureThe Stealth 360® and Diamondback 360®
Peripheral Orbital Atherectomy 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.
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
Systems treat calcified and fibrotic plaque in arterial vessels
throughout the leg and heart in a few minutes of treatment time,
and address many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. The
U.S. FDA granted 510(k) clearance for the use of the Diamondback
Orbital Atherectomy System in peripheral arteries in August 2007.
In October 2013, the company received FDA approval for the use of
the Diamondback Orbital Atherectomy System in coronary arteries. To
date, nearly 200,000 of CSI’s devices have been sold to leading
institutions across the United States. For more information, visit
the company’s website at www.csi360.com.
Safe HarborCertain 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, the statement in this press
release regarding the anticipated timing of the launch of the
ViperWire Advance with Flex Tip is a forward-looking statement.
These statements involve risks and uncertainties that could cause
results to differ materially from those projected, including, but
not limited to, production and marketing timelines 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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version on businesswire.com: http://www.businesswire.com/news/home/20150706005814/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorMark Sullivan,
651-900-7077msullivan@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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