Avinger Receives FDA Clearance of Pantheris SV Device
10 April 2019 - 10:00PM
Avinger, Inc. (Nasdaq: AVGR), a leading developer of image-guided,
catheter-based systems for the diagnosis and treatment of patients
with Peripheral Artery Disease (PAD), today announced that the
Company received 510(k) clearance from the U.S. Food & Drug
Administration (FDA) for its Pantheris SV (Small Vessel)
image-guided atherectomy system.
Pantheris SV, a product line extension of Avinger’s Lumivascular
image-guided atherectomy platform, is expected to expand the
available market for Pantheris by up to 50% and allow the Company
to address a larger portion of the estimated $500 million
atherectomy market. Designed with a lower profile and longer length
than Pantheris, Pantheris SV is indicated for the diagnosis and
treatment of PAD in small vessels (2 to 4 millimeters in diameter).
Pantheris SV incorporates key improvements introduced to the
platform with the launch of the next-generation Pantheris system in
June 2018, including a stiffer shaft for increased pushability, a
refined OCT imaging system, and an enhanced cutter design.
Pantheris SV received CE Marking in October 2018 and the first
patients were treated with the device in Germany in November. The
Company intends to initiate a limited launch of Pantheris SV in
several sites in the United States when commercial product is
available. Distribution of Pantheris SV is expected to be expanded
as the Company gains additional clinical experience, builds product
inventory, and receives purchasing approvals in new Lumivascular
sites.
“We are excited to receive U.S. pre-marketing clearance for
Pantheris SV, which we believe could expand our addressable market
for atherectomy procedures by as much as 50%,” said Jeff Soinski,
Avinger’s President and CEO. “With the clearance of this new
device, we are well-positioned to build on the positive momentum we
have seen in our Pantheris business since the introduction of the
next-generation system in 2018. Following our anticipated limited
launch of Pantheris SV, we plan on leveraging our growing
commercial infrastructure and installed base of Lumivascular
accounts to efficiently scale up the introduction of Pantheris SV
and drive growth of our Pantheris product family in the second half
of 2019.”
Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly
experienced interventionalist treating patients with small vessel
disease, commented, “This product line extension represents a
significant advancement for patients with PAD, in particular those
suffering from the complications of small vessel disease. Treating
small vessels presents a number of challenges and physicians have
had a limited set of minimally invasive tools that can provide safe
and effective outcomes for this high-risk patient population.
Pantheris SV uses a combination of directional atherectomy with
onboard image-guidance to provide several potential clinical
advantages, including an enhanced safety profile, the ability to
maximize luminal gain without causing vascular injury, and precise
vessel measurement capabilities.”
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, California. 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 Avinger’s Pantheris SV, its
distribution and commercialization and its potential market as well
as the growth of our Pantheris product family. 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 ability to demonstrate the benefits
of Pantheris SV and our Pantheris product family; the resource
requirements related to Pantheris SV; 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 Pantheris SV; 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-K filed with the Securities and Exchange
Commission on March 6, 2019. 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)
241-7942pr@avinger.com
Investor Contact:
Mark Weinswig Chief Financial Officer Avinger, Inc. (650)
241-7916 ir@avinger.com
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