Avinger Receives CE Marking Approval for In-Stent Restenosis Treatment Indication With Pantheris Image-Guided Atherectomy
September 26 2017 - 4:01PM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for Peripheral Artery Disease (PAD), today announced
Conformité Européenne (CE) Marking approval for treating in-stent
restenosis with the Pantheris® Lumivascular atherectomy system.
In-stent restenosis occurs when a previously
blocked artery treated with a stent becomes narrowed again,
blocking blood flow. Physicians often face challenges when treating
in-stent restenosis both in terms of safety and efficacy. From a
safety standpoint, limitations in imaging techniques such as X-ray
fluoroscopy and the inability to control the directionality of
other treatment modalities’ mechanism of action creates the concern
of potentially impacting the integrity of the stent during the
intervention. In terms of efficacy, current therapies for in-stent
restenosis such as balloon angioplasty suffer from high rates of
recurrent renarrowing within stents.
“The demand for improved treatment options for
in-stent restenosis is growing as physicians experience the
accurate visualization and precision provided by state-of-the-art
technologies such as the Pantheris Lumivascular atherectomy
system,” said Jeff Soinski, Avinger’s president and CEO. “CE
Marking for this particular indication is an important milestone
for Avinger that addresses an area of unmet clinical need for
patients suffering from PAD. Onboard image guidance coupled with
directional plaque excision offers the interventionist clear
benefits when treating in-stent restenosis and represents another
opportunity to improve patient outcomes.”
“Two elements thoughtful interventionists want to
avoid during intervention are adventitia and stent struts,” said
John B. Simpson, Ph.D., M.D., founder and executive chairman.
“Intravascular visualization combined with a directional mechanism
in real time provides operators the information and precision
needed to treat only diseased tissue without coming into contact
with the stent struts or adventitia.”
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, that 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 using
real-time OCT image guidance, physicians can more accurately
navigate their devices to treat PAD 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, CA. For more information, please
visit www.avinger.com.
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
Avinger (NASDAQ:AVGR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Avinger (NASDAQ:AVGR)
Historical Stock Chart
From Apr 2023 to Apr 2024