AngioDynamics Launches PATHFINDER I Registry to Evaluate Performance and Clinical Outcomes of the AURYON™ Atherectomy System
January 16 2020 - 11:00AM
Business Wire
AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of
innovative, minimally invasive medical devices for vascular access,
peripheral vascular disease, and oncology, today announced the
launch of the PATHFINDER I: Post-Market Registry (PATHFINDER
I-Registry, EX-PAD-05), a pilot study to evaluate the safety and
efficacy of the Company’s AURYON Atherectomy System in the
treatment of de novo, re-stenotic, and in-stent restenosis (ISR)
lesions in infrainguinal arteries of patients with Peripheral
Artery Diseases (PAD).
The AURYON Atherectomy System, previously known as the Eximo
B-Laser, is a proprietary 355nm wavelength laser-technology
platform that was acquired by AngioDynamics in October 2019.
“The PATHFINDER I study will provide valuable, scientifically
backed data to further differentiate the AURYON system from
competitive products in this space and build upon the excellent
long-term results that patients experienced during the IDE,” said
Juan Carlos Serna, AngioDynamics Vice President for Clinical
Affairs & Healthcare Economics.
AngioDynamics’ PATHFINDER I Registry is a prospective,
non-randomized, single arm, multicenter observational study that
will evaluate the performance of the AURYON Atherectomy System
during procedures and measure clinical outcomes, both intermediate
and long-term. A total of 100 eligible PAD patients treated with
the AURYON Atherectomy System in a post-market setting will be
enrolled and tracked for a 36-month period after the initial
procedure.
Initial findings from the pilot registry study will contribute
to a subsequent large pivotal phase registry that is expected to
include approximately 1,000 patients. Visit
www.clinicaltrials.gov/ct2/show/NCT04229563 for more information
about the PATHFINDER I Registry.
As previously communicated, the commercial release of the AURYON
Atherectomy System in the United States will occur in the second
half of AngioDynamics’ current fiscal year. For more information
about the AURYON Atherectomy System, visit Auryon-PAD.com for more
information.
About AngioDynamics, Inc.
AngioDynamics, Inc. is a leading provider of innovative,
minimally invasive medical devices used by professional healthcare
providers for vascular access, peripheral vascular disease, and
oncology. AngioDynamics’ diverse product lines include
market-leading ablation systems, vascular access products,
angiographic products and accessories, drainage products,
thrombolytic products and venous products. For more information,
visit www.angiodynamics.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20200116005489/en/
Investor Relations Contact:
AngioDynamics, Inc. Steve Trowbridge 518-795-1408
strowbridge@angiodynamics.com
Media Contact:
AngioDynamics, Inc. Saleem Cheeks 518-795-1174
scheeks@angiodynamics.com
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