Avinger Announces New FDA Clearance for Lumivascular Imaging Console, Enabling Vessel Measurement Via Touchscreen
December 22 2016 - 7:30AM
Technology Upgrade to Lightbox L250 Allows
Physicians to Accurately Assess Luminal Gain
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for Peripheral Artery Disease (PAD), today announced
that the company has received a new 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for its Lightbox L250 imaging
console. With this new FDA clearance, the Lightbox L250 now
provides detailed measurement of vessels with a few simple taps to
a touch screen, helping further improve visualization inside the
vessel before, during, and after Pantheris™ Lumivascular
atherectomy procedures for the treatment of PAD.
In addition, this enhanced technology allows the clinician to
create borders and measurements in seconds to determine the area of
any vessel feature, automatically generate minimum and maximum
diameters within a given area, and generate vessel size
measurements for reference vessel sizing to facilitate adjunctive
therapies. Users can easily add and move reference points for even
greater control.
“The ability to obtain an accurate and real-time measurement
from inside a diseased vessel is vital – it provides us key pieces
of information that we can use to determine the levels of stenosis
and luminal gain both during and immediately after an atherectomy
procedure,” said Sean Janzer, M.D., interventional cardiologist
from Einstein Medical Center in Philadelphia, Pa. “Additionally,
the measurements made possible by this latest upgrade will help
optimize both the atherectomy and adjunctive therapies performed
post-atherectomy, such as the deployment of a drug-coated balloon
or placement of a stent.”
“We are excited to announce this latest FDA clearance, which
greatly enhances the ability of the Lightbox L250 to accurately
provide vessel measurements, further advancing the potential of
Lumivascular technology to dramatically improve patient care,” said
John B. Simpson, Ph.D., M.D., Avinger’s founder and executive
chairman. “Achievement of this FDA clearance is a key step in our
ongoing commitment to ensuring our users have the latest
technological advancements at their fingertips for greater
confidence and control in treating 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 a directional atherectomy
procedure by using an imaging modality called optical coherence
tomography, or OCT, which is displayed on the Lightbox console. In
the past, physicians have had to rely solely on X-ray as well as
tactile feedback to guide their tools 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.
The new software will be made available to all existing L250
users at no cost and will be incorporated in all future Lightbox
products as part of the standard software packages.
About Avinger, Inc.
Avinger, Inc. is a commercial-stage medical device company that
designs, manufactures and sells image-guided catheter-based systems
for the treatment of patients with peripheral artery disease (PAD).
PAD is characterized by a build-up of plaque in the arteries that
supply blood to the arms and legs. The company’s mission is to
dramatically improve the treatment of vascular disease through the
introduction of products based on its Lumivascular platform, the
only intravascular image-guided system of therapeutic catheters
available in this market. Avinger’s current Lumivascular products
include the Lightbox imaging console, the Ocelot family of
catheters, which are designed to penetrate total arterial
blockages, known as chronic total occlusions, or CTOs, and
Pantheris™, the first-ever image-guided atherectomy device,
designed to precisely remove arterial plaque in PAD patients. For
more information, please visit www.avinger.com.
Investor Contact:
Matt Ferguson
Avinger, Inc.
(650) 241-7917
ir@avinger.com
Media Contact:
Jessica Volchok
Phone: +1.424.271.6471
Email: jessica@nicoleosmer.com
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