Avinger Announces Treatment of First Patients Globally With Next Generation Pantheris
January 03 2018 - 8:30AM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for peripheral artery disease (PAD), announced that Arne
Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in
Münster, Germany, has successfully treated the first seven patients
with the next generation Pantheris Lumivascular atherectomy system.
Dr. Schwindt, an experienced operator of Lumivascular technology,
used the next generation Pantheris to treat seven separate patients
with a variety of lesion types, including in-stent restenosis
(ISR), a calcified lesion, and a chronic total occlusion, in
arteries above and below the knee.
The next generation Pantheris design includes 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 device is available
in limited supply for commercial sale in the EU; it is not
available commercially in the United States at this time.
In each of the seven cases, Pantheris performed as intended, and
Dr. Schwindt made note of the design features that enabled
significant performance improvements as compared to previous
versions of the device, including better directional control of the
cutter blade for more precise atherectomy. Dr. Schwindt also
provided feedback about the increased maneuverability of the
system, greater tissue capture versus the similarly sized previous
version of Pantheris, increased efficiency and ease of cleaning the
device between insertions, and high quality imaging in a variety of
vessel diameters.
In commenting on his initial cases, which included a patient
with a total occlusion of a stent and multiple below-the-knee
lesions, Dr. Schwindt noted, “Next generation Pantheris with
real-time image guidance enabled me to see the stent struts and
precisely target and remove substantial amounts of tissue that had
grown into the stent. In two patients the disease extended below
the knee. Image-guided atherectomy with the next generation
Pantheris made it possible to precisely target and remove
atherosclerotic plaque in this region while conserving the deep
wall components and thus reducing the risk of perforations in these
small vessels. The angiographic outcome was excellent.”
“We are thrilled that Dr. Schwindt was the first in the world to
use the next generation of Pantheris, especially given the
excellent outcomes for patients in this initial experience with the
device,” said Jeff Soinski, Avinger’s president and CEO. “These
cases helped to validate the enhancements we have made to
Pantheris, both in terms of performance and reliability. We believe
the initial results generated by Dr. Schwindt with the device
represent an important step both for Avinger and for the evolution
of treatment for patients with PAD.”
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 PantherisÒ 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 performance of our next-generation device and its
potential implications and improvements over prior versions of the
device. 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 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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