Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States
July 29 2019 - 8:00AM
Avinger, Inc. (Nasdaq: AVGR), a commercial-stage medical device
company marketing the first and only intravascular image-guided,
catheter-based system for diagnosis and treatment of Peripheral
Artery Disease (PAD), today announced that physicians in four U.S.
sites have successfully treated several patients with the Pantheris
SV (Small Vessel) image-guided atherectomy system. These initial
cases are part of a limited launch at up to 13 leading clinical
centers prior to expanding commercial distribution to additional
treatment facilities in the U.S.
Pantheris SV, a product line extension of Avinger’s onboard
image-guided atherectomy platform, expands Avinger’s portfolio of
atherectomy devices for the treatment of PAD and increases the
number of addressable procedures for the Company’s Lumivascular
technology by allowing physicians to target more distal regions of
the vasculature in small diameter vessels. The device features a
140 cm catheter length and a smaller six French (6F) profile, and
incorporates key improvements introduced to the platform with the
next generation Pantheris catheter in May 2018. Pantheris SV
received CE Marking in October 2018 and the first several patients
were treated with the device in Germany since that time. The
Company has incorporated additional design improvements into the
U.S. limited launch version of the technology, which is anticipated
to be introduced into the European market later this year.
Dr. Edward Pavillard, a vascular surgeon at PA Vascular
Institute in King of Prussia, Pennsylvania performed the first
Pantheris SV case in the United States. As part of his practice,
Dr. Pavillard treats a high volume of patients with small vessel
peripheral artery disease, which often involve very complicated
interventions. Commenting on his first case, Dr. Pavillard noted,
“Pantheris SV’s onboard image-guidance highlighted the eccentric
nature of the disease and allowed me to target just the removal of
the plaque, while leaving minimal residual stenosis without
adjunctive therapy. This technology is the only atherectomy device
that I would feel safe using in this type of disease, and having a
live image was key to the success of the procedure. The patient had
brisk blood flow post-intervention, zero complications in a
critical area of the vasculature, and the whole procedure was
completed without the use of contrast and with minimal fluoroscopy
time.”
“The positive outcomes that interventionalists were able to
achieve in these initial cases using Pantheris SV highlight the
potential for this technology,” commented Jeff Soinski, Avinger’s
President and CEO. “With fewer durable treatment options for small
vessel disease available to physicians, we believe that Pantheris
SV addresses an unmet clinical need by offering a unique
combination of luminal gain and safety. We continue to see positive
momentum with our image-guided atherectomy platform and believe
that Pantheris SV could increase our available market for these
procedures by as much as 50%, while driving adoption through our
current commercial infrastructure and customer base.”
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 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 images 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, due 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.
Public Relations Contact:Phil PreussVP of
Marketing & Business OperationsAvinger, Inc.(650)
241-7942pr@avinger.com
Investor Contact:Mark WeinswigChief Financial
OfficerAvinger, Inc.(650) 241-7916ir@avinger.com
Matt Kreps Darrow Associates Investor Relations (214) 597-8200
mkreps@darrowir.com
Safe Harbor DisclosureThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Such forward-looking
statements include, but are not limited to, statements related to
the Company's launch of design improvements to Pantheris SV, the
introduction of such improvements into the European market, the
patient outcomes relating to Pantheris SV, the available market for
procedures using Pantheris SV and other statements that are not
historical facts. Forward-looking statements are based on
management’s current expectations and are subject to risks and
uncertainties that may cause actual results or events to differ
materially from those projected. These risks and uncertainties,
many of which are beyond our control, include: risks relating to
Pantheris SV’s effectiveness; patient outcomes relating to
Pantheris SV; our ability to increase the available market for
procedures using Pantheris SV; risks relating to our growth
strategy; our ability to obtain, perform under and maintain
financing and strategic agreements and relationships; risks
relating to the results of development activities; our ability to
attract, integrate and retain key personnel; our need for
substantial additional funds; patent and intellectual property
matters; competition; as well as other risks described in the
section entitled “Risk Factors” and elsewhere in our Annual Report
on Form 10-K filed with the SEC on March 6, 2019 and in our other
filings with the SEC, including, without limitation, our reports on
Forms 8-K and 10-Q, all of which can be obtained on the SEC website
at www.sec.gov. Readers are cautioned not to place undue reliance
on the forward-looking statements, which speak only as of the date
on which they are made and reflect management’s current estimates,
projections, expectations and beliefs. We expressly disclaim any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in our expectations or any changes in events,
conditions or circumstances on which any such statement is based,
except as required by law.
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