Trial Evaluates Effectiveness of Innovative
Auryon Atherectomy System in Complex Below-the-Knee Cases
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative
medical technology company focused on restoring healthy blood flow
in the body's vascular system, expanding cancer treatment options
and improving patient quality of life, today announced the start of
a Randomized Study of the Auryon Atherectomy System Used in
Combination with Standard Balloon Angioplasty Versus Standard
Balloon Angioplasty Alone Treating Infrapopliteal Lesions in
Subjects with Critical Limb Ischemia Below-the-Knee (AMBITION
BTK).
AMBITION BTK is a multicenter, randomized controlled trial (RCT)
designed to evaluate the clinical outcomes of the Auryon
Atherectomy System in combination with standard balloon angioplasty
compared to standard balloon angioplasty alone for the treatment of
infrapopliteal lesions in patients with critical limb ischemia. The
trial will enroll up to 200 subjects across up to 30 hospital-based
sites. Additionally, up to 1,500 subjects treated with the Auryon
Atherectomy System at the same sites who do not meet the
eligibility criteria of the RCT will be enrolled in a companion
Registry.
Lower extremity peripheral artery disease (PAD) affects more
than 230 million adults worldwide and is associated with an
increased risk of various adverse clinical outcomes.1 In its most
severe form, critical limb ischemia patients are often treated with
lower extremity amputation (LEA).2
“We are dedicated to expanding innovative treatment options for
peripheral artery disease, particularly in challenging cases like
below-the-knee lesions,” said Juan Carlos Serna, AngioDynamics
Senior Vice President of Scientific and Clinical Affairs. “The
AMBITION BTK RCT and Registry represents an important advancement
in evaluating the clinical benefits of the Auryon Atherectomy
System. Physicians have expressed strong interest in the platform's
unique capabilities, and we are eager to demonstrate further its
potential to improve outcomes for patients with critical limb
ischemia.”
The Auryon laser can be used to treat all infrainguinal lesion
types, including above-the-knee (ATK), below-the-knee (BTK) and
In-Stent Restenosis (ISR)3,4,5,6 and to date, it has been used to
treat more than 100,000 patients7 in the United States and
worldwide.
“With the global rise in diabetes, we are seeing a growing
number of patients with severe tibial disease,” said AMBITION BTK
Co-Principal Investigator Anahita Dua, MD, MS, MBA, FACS, vascular
surgeon at Massachusetts General Hospital and an associate
professor of Surgery at Harvard Medical School. “In the United
States, treatment options for below-the-knee lesions remain
limited, often relying primarily on POBA (Percutaneous Old Balloon
Angioplasty). These patients frequently present with tibial disease
that can extend throughout the entire vessel. An innovative tool
like the Auryon laser, which can restore laminar flow, could be a
game-changer in their care.”
AMBITION BTK builds upon the positive outcomes of a prior
multicenter, prospective trial that evaluated the safety and
effectiveness of the Auryon laser atherectomy system in treating
BTK lesions in patients with limb ischemia. The earlier study
successfully treated 61 complex, calcified lesions across four U.S.
centers in 60 patients, achieving strong clinical outcomes with
minimal complications. These results demonstrated the System's
ability to safely and effectively address challenging BTK cases,8
leading to the development of the AMBITION BTK RCT and
Registry.
“The AMBITION BTK RCT and Registry represents an important
advance in the evidence supporting the benefits of laser
atherectomy in achieving acute and long-term procedural success,”
said AMBITION BTK Co-Principal Investigator Ehrin Armstrong, FACC,
FSCAI, FSVM, MD, MSc, Interventional Cardiologist and Vascular
Disease, Director of Clinical Research, Advanced Heart and Vein
Center. “The trial will address an important unmet need for
patients with critical limb ischemia and tibial artery disease. The
data for the trial will also help better understand the Auryon
laser's unique mechanism of action in complex and calcified
lesions.”
The technology underlying the Auryon Atherectomy System has been
shown in clinical studies to be effective in treating lesions
ranging from soft plaque to severely calcified.3,4,5 The System
uses a 355nm wavelength laser platform, enabling the use of short
UV laser pulses with targeted biological reactions that are
effective in treating PAD while minimizing the risk of perforation
and preserving the ability to vaporize lesions without thermal
ablation.3,5,6,9,10
On February 1, the Company will host its inaugural
Cardiovascular Scientific Forum (CVSF). The event will bring
together leading physicians and thought leaders in the
cardiovascular field to present groundbreaking research, discuss
emerging clinical trends, and showcase advancements shaping the
future of patient care, including the AMBITION BTK RCT and
Registry.
Visit https://clinicaltrials.gov/study/NCT06777901 for more
information about the AMBITION BTK RCT and Registry.
For important risk information, visit
www.angiodynamics.com/about-us/risk-information/.
About the Auryon Atherectomy System
The Auryon Atherectomy System uses innovative technology to
deliver powerful treatment of arterial occlusions. The Auryon
Atherectomy System is the first laser atherectomy system to
efficiently treat any lesion type, any lesion length, at any lesion
location, with minimal impact on vessel walls.3,5,9,10 The Auryon
Atherectomy System uses solid-state laser technology for the
treatment of PAD and is FDA cleared with an indication for
treatment, including atherectomy, of infrainguinal stenoses and
occlusions, including ISR.4,6 The Auryon System’s targeted
biological reactions minimize the risk of perforation and preserve
the ability to vaporize lesions without thermal ablation.3,5,9,10
The Auryon System uses a 355nm wavelength laser platform which
enables the use of longer wavelengths and shorter pulses to produce
a groundbreaking delivery of short UV laser pulses.4 For more
information, please visit www.Auryon-PAD.com.
About AngioDynamics, Inc.
AngioDynamics is a leading and transformative medical technology
company focused on restoring healthy blood flow in the body’s
vascular system, expanding cancer treatment options and improving
patient quality of life.
The Company’s innovative technologies and devices are chosen by
talented physicians in fast-growing healthcare markets to treat
unmet patient needs. For more information, visit
www.angiodynamics.com.
Safe Harbor
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements regarding AngioDynamics’ expected future financial
position, results of operations, cash flows, business strategy,
budgets, projected costs, capital expenditures, products,
competitive positions, growth opportunities, plans and objectives
of management for future operations, as well as statements that
include the words such as “expects,” “reaffirms,” “intends,”
“anticipates,” “plans,” “believes,” “seeks,” “estimates,”
“projects,” “optimistic,” or variations of such words and similar
expressions, are forward-looking statements. These forward-looking
statements are not guarantees of future performance and are subject
to risks and uncertainties. Investors are cautioned that actual
events or results may differ materially from AngioDynamics’
expectations, expressed or implied. Factors that may affect the
actual results achieved by AngioDynamics include, without
limitation, the scale and scope of the COVID-19 global pandemic,
the ability of AngioDynamics to develop its existing and new
products, technological advances and patents attained by
competitors, infringement of AngioDynamics’ technology or
assertions that AngioDynamics’ technology infringes the technology
of third parties, the ability of AngioDynamics to effectively
compete against competitors that have substantially greater
resources, future actions by the FDA or other regulatory agencies,
domestic and foreign healthcare reforms and government regulations,
results of pending or future clinical trials, overall economic
conditions (including inflation, labor shortages and supply chain
challenges including the cost and availability of raw materials),
the results of on-going litigation, challenges with respect to
third-party distributors or joint venture partners or
collaborators, the results of sales efforts, the effects of product
recalls and product liability claims, changes in key personnel, the
ability of AngioDynamics to execute on strategic initiatives, the
effects of economic, credit and capital market conditions, general
market conditions, market acceptance, foreign currency exchange
rate fluctuations, the effects on pricing from group purchasing
organizations and competition, the ability of AngioDynamics to
obtain regulatory clearances or approval of its products, or to
integrate acquired businesses, as well as the risk factors listed
from time to time in AngioDynamics’ SEC filings, including but not
limited to its Annual Report on Form 10-K for the year ended May
31, 2024. AngioDynamics does not assume any obligation to publicly
update or revise any forward-looking statements for any reason.
AngioDynamics, the AngioDynamics logo and Auryon are trademarks
and/or registered trademarks of AngioDynamics, Inc., an affiliate
or subsidiary. All other trademarks are property of their
respective owners.
1 https://www.ahajournals.org/doi/10.1161/CIR.0000000000001005 2
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107174/#:~:text=In%20its%20most%20severe%20form,the%20performing%20of%20major%20LEA
3 Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich
I, et al. Novel laser-based catheter for peripheral atherectomy:
6-month results from the Eximo Medical B-LaserTM IDE study.
Catheter Cardiovasc Interv. 2019;1-8. 4 Auryon System Indications
for Use 5 Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo
G, Cawich I, et al. Acute and 30-day safety and effectiveness
evaluation of Eximo Medical’s B-LaserTM, a novel atherectomy
device, in subjects affected with infrainguinal peripheral arterial
disease: Results of the EXPAD-03 trial. Cardiovas Revasc Med.
2020;21(1):86-92 6 Built-in aspiration available only with the 2.0-
and 2.35-mm catheters. 7 AngioDynamics’ J.P. Morgan Healthcare
Conference Presentation
https://investors.angiodynamics.com/static-files/f7e7b49f-744d-4169-9a66-95a78d2f1525.
Published 2025. 8 ClinicalTrials.gov. (2023). Evaluation of the
safety and efficacy of the Auryon Atherectomy System for the
treatment of below-the-knee arteries in patients with chronic
limb-threatening ischemia (NCT05284240). U.S. National Library of
Medicine.
https://clinicaltrials.gov/study/NCT05284240?term=NCT05284240&rank=1
9 Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective
tissue ablation using laser radiation at 355 nm in lead extraction
by a hybrid catheter; a preliminary report. Lasers Surg Med.
2016;48(3):281-287 10 Vogel A, Venugopalan V. Mechanisms of pulsed
laser ablation of biological tissues. Chem Rev.
2003;103(2):577-644
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version on businesswire.com: https://www.businesswire.com/news/home/20250130014689/en/
Investors: Stephen Trowbridge Executive Vice President
& CFO 518-795-1408 strowbridge@angiodynamics.com
Media: Saleem Cheeks Vice President, Communications
518-795-1174 scheeks@angiodynamics.com
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