Avinger Announces Verified Data of 24-Month Outcomes from the Pivotal VISION Study of Lumivascular Technology for Peripheral ...
May 31 2017 - 12:20PM
Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative
treatments for peripheral artery disease (PAD), today announced
positive two-year clinical data from the pivotal VISION study of
the company’s Lumivascular™ technology.
The VISION study was designed to evaluate the safety and
effectiveness of Avinger’s Pantheris® system to perform
directional atherectomy while, for the first time ever, allowing
physicians to use real-time intravascular imaging to aid in the
removal of plaque from diseased lower extremity arteries. Data from
the study, which demonstrated successful achievement of all primary
and secondary safety and effectiveness endpoints, supported U.S.
Food and Drug Administration (FDA) 510(k) clearance of
the system in 2016.
Twenty four (24) month follow-up results from 89 patients were
presented by Patrick Muck, M.D., Chief of Vascular Surgery at Good
Samaritan Hospital in Cincinnati, Ohio, at New Cardiovascular
Horizons (NCVH) in New Orleans, Louisiana. This includes an
additional 34 patients beyond the interim data set presented on
January 25, 2017. Data presented today remain subject to adjustment
based on final statistical analysis and review by the study’s
clinical events committee.
Key highlights of the presentation include:
- Kaplan Meier survival probability measured 82% freedom from
target lesion revascularization (TLR) at 12 months by patient (84%
by lesion) and 74% freedom from TLR at 24 months by patient (76% by
lesion)
- The VISION 24-month Kaplan Meier freedom from target lesion
vascularization at 24 months remained stable between 18 and 24
months
- Statistically significant improvements in ankle brachial index
(ABI) and Rutherford classification at 30 days were maintained
through 24 months
- A majority of lesions were treated using standalone optical
coherence tomography (OCT) guided atherectomy with the Pantheris
catheter, with only 9.6% (n=19/198) receiving adjunctive drug
coated balloon (DCB) therapy and only 5% (n=10/198) receiving
adjunctive stent therapy
“The complete VISION 24-month data demonstrates positive
longer-term sustained results for patients treated with Pantheris,
and importantly, these patients have largely avoided the need for a
repeat procedure in a two-year timeframe,” commented Dr. Muck.
“Considering that the outcomes were generated at the hands of brand
new users with a first-generation clinical trial device, such
positive results represent an important step forward for Pantheris
in the clinical setting.”
“These excellent results continue to reinforce our enthusiasm
for the Pantheris System,” said Dr. John B. Simpson, Avinger’s
Founder and Executive Chairman. “We are gratified that Lumivascular
technology is improving the lives of patients with PAD, including
many facing amputation. In the meantime we continue to refine the
system, with Pantheris 3.0, our next-generation atherectomy
catheter, and a lower-profile Pantheris device currently in
development.” About Avinger, Inc. Founded in
2007, Avinger, Inc. is a commercial-stage medical device company
that designs and develops the first-ever image-guided,
catheter-based systems that diagnoses and treats patients with
peripheral arterial disease (PAD). Avinger is dedicated to
radically changing the way vascular disease is treated through
their Lumivascular platform which currently consists of the
Lightbox imaging console, the Ocelot family of catheters designed
for chronic total occlusions (CTOs), and Pantheris designed for
atherectomy. Avinger is based in Redwood City, CA. For
more information, please visit www.avinger.com.
Public Relations Contact:
Phil Preuss
Avinger, Inc.
(650) 241-7900
pr@avinger.com
Investor Contact:
Matt Ferguson
Avinger, Inc.
(650) 241-7917
ir@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