Avinger Announces 510(k) Filing of Pantheris Small Vessel Device
August 30 2018 - 8:30AM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for peripheral artery disease (PAD), today announced the
Company submitted a new 510(k) application to the U.S Food &
Drug Administration (FDA) for the Pantheris SV (Small Vessel)
Lumivascular atherectomy system.
Pantheris SV is a line extension of the Pantheris family of
catheters, the first and only image-guided atherectomy devices for
the treatment of PAD. Designed with a lower profile and longer
length, Pantheris SV is intended to expand the number of
addressable procedures for Pantheris by allowing physicians to
target lesions in smaller diameter vessels and more distal regions
of the vasculature. Pantheris SV incorporates key improvements
introduced to the platform with the clearance of the next
generation Pantheris system in May 2018, including a stiffer shaft
for increased pushability, a refined OCT imaging system, a more
robust nosecone, and an enhanced cutter design.
“Effective tools to address lesions in smaller vessels represent
an important unmet clinical need in the treatment paradigm for
PAD,” said Dr. Jaafer Golzar, Avinger’s Chief Medical Officer.
“There is a lack of long-term durability noted with other treatment
options in this area of the vasculature. However, the concept of
pairing onboard image-guidance with a directional atherectomy
system could provide a number of significant clinical advantages,
including an enhanced safety profile, the ability to maximize
luminal gain without causing vascular injury, and a potential
enhancement in the uptake of anti-restenotic drug therapy,” Dr.
Golzar continued.
Jeff Soinski, Avinger’s President and CEO commented, “This
submission represents an important milestone in positioning the
company for growth in 2019. We are hopeful that this filing will
lead to U.S. market availability of Pantheris SV by early 2019,
which we believe would allow us to address a significantly larger
portion of the estimated $500 million atherectomy market. We are
excited to get this next generation small vessel device into the
hands of Lumivascular physicians.”
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). PAD is
estimated to affect over 12 million people in the U.S. and over 200
million worldwide. 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, CA. For more information, please visit
www.avinger.com.
Forward-Looking Statements This 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 new products, the timeline associated
therewith and the benefits of Pantheris SV. Such statements
are based on current assumptions that involve risks and
uncertainties that could cause actual outcomes and results to
differ materially. 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; experiences of high-volume users of our products may lead
to better patient outcomes than those of physicians that are less
proficient; 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 report on Form 10-Q filed with the
Securities and Exchange Commission on August 13, 2018. 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 Preuss VP of
Marketing & Business Operations Avinger, Inc. (650) 241-7900
pr@avinger.com
Investor Contact: Mark Weinswig Chief Financial
Officer Avinger, Inc. (650) 241-7916 ir@avinger.com
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