225-cm Catheter Length Expands Access Points in
Atherectomy Procedures to Help Reduce Access Site Complications and
Accelerate Patient Recovery
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 that the
United States Food and Drug Administration (FDA) has cleared the
Auryon XL Catheter, a 225-cm radial access catheter, for use with
the Auryon Atherectomy System in the treatment of Peripheral
Arterial Disease (PAD).
According to the American Heart Association, PAD affects 8.5
million Americans and 200 million people worldwide each year1.
Studies have shown that radial access is associated with a
significantly lower risk of major bleeding and access site
complications when compared to femoral access2,3 in the treatment
of patients.
“Since its launch in September 2020, the Auryon Atherectomy
System, with its innovative solid-state laser technology, has
fundamentally changed patient treatment for PAD and quickly become
an essential tool for providers and patients,” said Kimberly
Nelson, Senior Director of Auryon Global Marketing at
AngioDynamics, Inc. “Our entry into the Radial-to-Peripheral (R2P)
space with Auryon XL is an important part of our focus on advancing
the quality of care delivery and it demonstrates our commitment to
meeting the unmet needs of patients and atherectomy providers.”
The Auryon XL Catheter, available in 0.9 mm and 1.5 mm
diameters, expands treatment access points in atherectomy
procedures for PAD. Use of a general radial access catheter may
reduce incidents of major bleeding, when compared to femoral
access, by more than 70%3. Additionally, it may eliminate the need
for the use of femoral closure devices and allow for the treatment
of bilateral disease in a single session, supporting improved
patient mobility, earlier discharge and faster patient recovery
times.
"Radial access is more than an entry point; it's a
transformative expressway to enhanced patient outcomes,” said Ankur
Lodha, M.D., interventional cardiologist at Cardiovascular
Institute of the South located in Lafayette, Louisiana. “With an
innovative design and its ease-of-use, the Auryon XL Catheter
brings significant advancements to radial procedures as the first
non-orbital atherectomy device – setting a new standard for laser
atherectomy technology.”
Following FDA 510(k) clearance, AngioDynamics initiated a
limited market release of the Auryon XL Catheter in the United
States in January 2024 and expects to enter full market release in
February 2024.
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)5,6,8,11, and to date, it has been used to
treat more than 50,000 patients7 in the United States.
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 calcified5,6,8. 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
ablation5,8-10.
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 walls5,8-10. 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 ISR6,11. The Auryon System’s targeted
biological reactions minimize the risk of perforation and preserve
the ability to vaporize lesions without thermal ablation5,8-10. 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 pulses6. For more
information, please visit www.Auryon-PAD.com.
About Cardiovascular Institute of the South
Founded by Dr. Craig Walker in 1983, Cardiovascular Institute of
the South (CIS) is a world-leader in preventing, detecting and
treating cardiovascular and peripheral vascular disease. CIS offers
a comprehensive heart and vascular program with expert physicians
trained in many specialties, including internal medicine, nuclear
cardiology, electrophysiology, lipid management, coronary artery
disease, peripheral vascular disease, structural heart and valve
disease, venous disease and interventional procedures. CIS has
earned international acclaim as a pioneer of research, development
and education, as well as an innovator in the treatment of
peripheral vascular disease. With a dedicated team of more than
1,075 team members, CIS provides comprehensive cardiovascular care
at 21 locations across Louisiana and Mississippi, with 11
telemedicine programs. CIS has also been recognized by Modern
Healthcare as a Best Place to Work in Healthcare for four years in
a row. CIS remains at the forefront of technology, providing the
highest-quality, compassionate care. This mission has guided the
institute for 40 years of excellence.
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, 2023. 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.
References
- American Heart Association - PAD Resources. www.heart.org.
https://www.heart.org/en/health-topics/peripheral-artery-disease/pad-resources.
Published 2021. Accessed January 12, 2024.
- KHAN, B., KHAN, A., MUHAMMAD , A., SAWAR , S., RAHMAN , F.,
& HASSAN , M. (2023). COMPARISON OF THE EFFECTIVENESS OF RADIAL
VERSUS FEMORAL ACCESS FOR DIAGNOSTIC AND THERAPEUTIC PROCEDURES IN
PATIENTS WITH PERIPHERAL ARTERIAL DISEASE. Biological and Clinical
Sciences Research Journal, 2023(1), 244.
https://doi.org/10.54112/bcsrj.v2023i1.244
- Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus
femoral access for coronary angiography or intervention and the
impact on major bleeding and ischemic events: a systematic review
and metaanalysis of randomized trials. Am Heart J.
2009;157(1):132
- Kern MJ. Radial Access in Practice. Tips for starting a
successful program. Cardiac Interventions Today. September/October
2015.
- 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.
- Auryon System Indications for Use
- AngioDynamics’ J.P. Morgan Healthcare Conference Presentation
https://investors.angiodynamics.com/static-files/35c51c12-b962-40b5-b349-22341e0d859b.
Published 2024.
- 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
- 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
- Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of
biological tissues. Chem Rev. 2003;103(2):577-644
- Built-in aspiration available only with the 2.0- and 2.35-mm
catheters.
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version on businesswire.com: https://www.businesswire.com/news/home/20240123524948/en/
Investor Relations: Stephen Trowbridge 518-795-1408
strowbridge@angiodynamics.com
Media: Saleem Cheeks 518-795-1174
scheeks@angiodynamics.com
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