Avinger Announces Expanded FDA Indications for Pantheris™ as Diagnostic Imaging Device
October 19 2016 - 4:01PM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for Peripheral Artery Disease (PAD), today announced
that the company has received expanded indications from the U.S.
Food and Drug Administration (FDA) recognizing the Pantheris™
Lumivascular atherectomy system as a technology that can be used
for both therapeutic and diagnostic purposes.
Pantheris is the first and only image-guided atherectomy
device to receive clearance for diagnostic imaging as well as for
the simultaneous treatment of PAD. This expanded indication
clarifies that, in addition to treatment of PAD, Pantheris may be
used by physicians to identify the vessel lumen and wall structures
such as intima, internal elastic lamina (IEL), media, external
elastic lamina (EEL) and stent struts, as well as vessel
morphologies such as calcium, thrombus, fibroatheromas, and
necrotic cores.
“I am thrilled that Pantheris is now recognized as providing
important diagnostic imaging information that enhances physicians’
ability to deliver the most advanced treatments for vascular
disease,” said John B. Simpson, Ph.D., M.D., the company’s founder
and executive chairman. “This is one more step toward establishing
Lumivascular technology as a premier interventional platform for
physicians.”
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 in the Pantheris catheter 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. In the past,
physicians have had to rely solely on X-ray as well as touch and
feel to guide their tools while they try to treat complicated
arterial disease. With the Lumivascular approach, physicians can
more accurately navigate their devices to treat PAD lesions using
the guidance of OCT images generated from inside the artery. By
relying upon OCT images as an adjunct to fluoroscopy, exposure to
ionizing radiation may be reduced for healthcare workers and
patients.
“The FDA clearance of Pantheris as a diagnostic tool reflects
what we as clinicians have already seen first-hand in our
practices: that Pantheris OCT images provide important clinical
information during our procedures, allowing us to see complicated
plaque characteristics in real time as we treat the vessel,” said
Suhail Dohad, M.D., interventional cardiologist with Cedars Sinai
Hospital, Los Angeles, Calif. “With Pantheris, we can now reliably
assess disease extent while simultaneously treating disease,
allowing a greater level of accuracy and confidence.”
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
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