Avinger Announces First Patient Enrolled in its IDE Study of the Pantheris Image-Guided Atherectomy System for Treatment of I...
October 19 2017 - 04:01PM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for Peripheral Artery Disease (PAD), today announced
initiation of INSIGHT, a prospective, global, single arm,
multi-center study to evaluate the safety and effectiveness of the
Pantheris® Lumivascular Atherectomy System for treating in-stent
restenosis (ISR) in lower extremity arteries.
Up to 140 patients will be enrolled in the INSIGHT trial at up
to 20 U.S. and international centers. Sean Janzer, M.D. of Einstein
Medical Center and Glen Schwartzberg, M.D. of Baton Rouge General
Medical Center serve as co-principal investigators of the
study.
In-stent restenosis occurs when a blocked artery previously
treated with a stent becomes narrowed again, reducing 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 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, have high rates of recurrent renarrowing
within stents.
“For many patients experiencing in-stent restenosis, treatment
can result in additional harm and costs when other treatment
modalities fail to provide the information and precision needed to
see and treat the restenosed lesions,” said Dr. Janzer. “The
Pantheris Lumivascular Atherectomy System has the potential to
provide interventionalists with real-time intravascular imaging to
more precisely direct plaque excision and avoid interaction with
stent struts, leading to better patient outcomes in these often
challenging cases.”
“Minimally invasive treatment of arterial occlusive disease has
been limited in its application due to the occurrence of either
over or under treatment and the subsequent complications associated
with these events,” said Dr. Schwartzberg. “The revolutionary
concept of real-time imaging of the the vessel lumen during an
intervention will enhance an environment of safety and improved
outcomes in these high risk patients. This study applies the unique
Lumivascular technology to the difficult problem of in-stent
restenosis, for which there is no long-term successful
treatment.”
“We are pleased to initiate this new trial to gather additional
data on the benefits of the Pantheris Lumivascular Atherectomy
System and expand its indication for use. I was particularly
excited to join Dr. Schwartzberg and the welcoming caregivers at
Baton Rouge General for the first case of this important study,”
said John B. Simpson, PhD., M.D., Avinger’s founder and executive
chairman.
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
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