Avinger Announces 510(k) Filing of Next Generation Pantheris Device
December 21 2017 - 8:30AM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for peripheral artery disease (PAD), announced the
Company submitted a new 510(k) application to the U.S. Food &
Drug Administration (FDA) for its next generation Pantheris®
Lumivascular atherectomy system, the first-ever image-guided
atherectomy device for the treatment of PAD. The novel design
features covered in the filing include a simplified single balloon
system for both apposition of the device and occlusion of blood
flow, a stiffer shaft for increased pushability, a more robust nose
cone with the option for more tissue storage capacity, and an
enhanced cutter design. This next generation device is not
available for commercial sale in the U.S. at this time.
“We have received invaluable feedback from physician users that
our engineering team has incorporated into the design of our next
generation of Pantheris,” said Jeff Soinski, Avinger’s President
and CEO. “The upgraded features captured in this submission should
bring the next level of quality, efficiency and ease of use to the
product. We are hopeful that this filing will lead to FDA clearance
of the next generation device in the U.S. by early next year, which
would allow the product to be commercially available by the end of
the first quarter."
Patrick Muck, M.D., Chief of Vascular Surgery at Good Samaritan
Hospital in Cincinnati, Ohio, commented, “The Pantheris
Lumivascular atherectomy system, through its combination of onboard
image-guidance and directional plaque removal, has changed my
approach to treating peripheral artery disease. As a regular user
of the current version of Pantheris, I believe the proposed
enhancements represent an important step forward, and I am excited
to incorporate the next generation Pantheris into the mainstream of
my PAD treatment algorithm.”
Atherectomy is a minimally invasive treatment for PAD in which a
catheter-based device is used to remove plaque from a blood vessel.
Lumivascular technology allows physicians, for the first time ever,
to see from inside the artery during an atherectomy procedure by
using an imaging modality called optical coherence tomography, or
OCT, that is displayed on Avinger’s proprietary Lightbox console.
Physicians performing atherectomy with other devices must rely
solely on X-ray as well as tactile feedback to guide their
interventions while treating complicated arterial disease. With the
Lumivascular approach, physicians can more accurately navigate
their devices and treat PAD lesions, thanks to the real-time OCT
images generated from inside the artery, without exposing
healthcare workers and patients to the negative effects of ionizing
radiation.
About Avinger, Inc.
Avinger is a commercial-stage medical device company that
designs and develops the first-ever image-guided, catheter-based
system that diagnoses and treats patients with peripheral artery
disease (PAD). Avinger is dedicated to radically changing the way
vascular disease is treated through its Lumivascular platform,
which currently consists of the Lightbox imaging console, the
Ocelot family of chronic total occlusion (CTO) catheters, and the
Pantheris® family of atherectomy devices. Avinger is based in
Redwood City, California. For more information, please visit
www.avinger.com.
Forward-Looking StatementsThis news release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934 and the Private Securities Litigation Reform
Act of 1995. These forward-looking statements include statements
regarding the launch of next generation products and the timeline
associated therewith. Such statements are based on current
assumptions that involve risks and uncertainties that could cause
actual outcomes and results to differ materially. These risks and
uncertainties, many of which are beyond our control, include our
dependency on a limited number of products; our ability to
demonstrate the benefits of our Lumivascular platform; the resource
requirements related to Pantheris; the outcome of clinical trial
results; potential exposure to third-party product liability,
intellectual property and other litigation; lack of long-term data
demonstrating the safety and efficacy of our Lumivascular platform
products; reliance on third-party vendors; dependency on physician
adoption; reliance on key personnel; and requirements to obtain
regulatory approval to commercialize our products; as well as the
other risks described in the section entitled “Risk Factors” and
elsewhere in our quarterly Form 10-Q filing made with the
Securities and Exchange Commission on November 14, 2017. These
forward-looking statements speak only as of the date hereof and
should not be unduly relied upon. Avinger disclaims any obligation
to update these forward-looking statements.
Public Relations Contact:Phil PreussVP of
Marketing & Business OperationsAvinger, Inc.(650)
241-7900pr@avinger.com
Investor Contact:Matt FergusonChief Business
Officer & CFOAvinger, Inc.(650) 241-7917ir@avinger.com
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