Avinger Receives FDA Clearance of Next Generation Pantheris Device
May 23 2018 - 8:30AM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for peripheral artery disease (PAD), announced today
that the Company received 510(k) clearance from 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 peripheral artery disease.
Lumivascular is the only technology that combines real-time
intravascular imaging with highly effective catheters for the
treatment of PAD. Peripheral artery disease is projected to affect
more than 21 million people in the United States alone by 2020.
The new version of Pantheris received CE Marking approval in
December 2017, and patients have been successfully treated with
this new device in Germany since that time. Avinger’s next
generation Pantheris device includes a number of design
improvements, including a simplified single balloon system for both
apposition of the device and occlusion of blood flow, a stiffer
shaft for increased pushability, a reinforced nosecone with the
option for more tissue storage capacity, and an enhanced cutter
design. The Company intends to launch two versions of this product
(standard and extended length nosecone) into initial sites in the
U.S. immediately, and plans to incorporate the new design into the
INSIGHT IDE clinical trial currently in progress. INSIGHT is a
multi-center clinical study designed to evaluate the safety and
effectiveness of Pantheris for treating in-stent restenosis (ISR)
in lower extremity arteries. Distribution of the next generation
Pantheris will be expanded as the Company increases production and
gains purchasing approvals in additional Lumivascular sites.
“We are excited to introduce the next generation Pantheris to
our network of physicians here in the United States,” said Mr. Jeff
Soinski, Avinger’s President and CEO. “After extensive testing by
our R&D and operations teams, physician design validation, and
successful initial case experience in Europe across a variety of
different lesion types, we believe this next generation device will
significantly improve the user experience in terms of reliability,
efficiency, and ease of use across a spectrum of clinical
situations.”
Dr. Barry Tedder, M.D., Interventional Cardiologist at St.
Bernards Medical Center in Jonesboro, Arkansas, commented, “The
Pantheris Lumivascular atherectomy system has allowed me to treat
peripheral artery disease with more precision while largely
avoiding trauma to the blood vessel during an intervention. Unlike
some other products, this technology’s performance can stand on its
own but also enhance other forms of adjunctive therapy if needed,
while preserving future treatment options for the patient. As one
of the first users of the initial generations of Pantheris, I have
been eagerly awaiting the product enhancements incorporated into
the new system, which has the promise of not only improving ease of
use, but also providing a new level of operator control during the
procedure.”
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, the timeline
associated therewith and the benefits of the next generation
Pantheris, and its incorporation into clinical trials. 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 May 15, 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 PreussVP of
Marketing & Business OperationsAvinger, Inc.(650)
241-7900pr@avinger.com
Investor Contact:Matt FergusonChief Business
Officer & CFOAvinger, Inc.(650) 241-7916ir@avinger.com
Avinger (NASDAQ:AVGR)
Historical Stock Chart
From May 2024 to Jun 2024
Avinger (NASDAQ:AVGR)
Historical Stock Chart
From Jun 2023 to Jun 2024