Regulatory approval enables entry of Auryon
Atherectomy System in European market
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 European CE
Mark approval of the Auryon Atherectomy System, an innovative
technology for the treatment of Peripheral Artery Disease (PAD),
including Critical Limb Ischemia (CLI) and In-Stent Restenosis
(ISR)1,2,3.
The Auryon Atherectomy System uses revolutionary solid-state
laser technology to treat PAD lesions and occlusions effectively.
Auryon is the first laser atherectomy system to efficiently treat
lesions of any type, length, or location (above and below the
knee)1,2,3, with minimal impact on vessel walls.
“The CE Mark approval of the Auryon System is a significant
milestone that underscores our commitment to bringing safe and
effective solutions to healthcare professionals treating peripheral
artery disease,” said Laura Piccinini, AngioDynamics Senior Vice
President and General Manager of Endovascular Therapies and
International. “This approval validates the clinical value of the
Auryon System and allows us to expand our presence in Europe, as
the prevalence of PAD continues to grow across the region4. We are
committed to supporting physicians with innovative technologies
that empower them to deliver the best possible care when treating
some of the most challenging cases of this disease.”
The Auryon Atherectomy System, which received FDA 510(k)
clearance in 2020, has treated over 50,000 patients in the United
States5. The recent CE Mark approval now provides patients with PAD
in the European Union access to the Auryon System’s advanced laser
platform. This approval also expands the Company’s reach to a
global PAD market valued at $1.1 billion5.
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 calcified1,2,3. 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
ablation1,3,8,9.
The Auryon Atherectomy System features aspiration and off-set
capability in certain catheter sizes, allowing clinicians to
address the risk of embolization and to treat all lesion types1,
while answering a need for non-surgical intervention options for
PAD, including ISR, and CLI.
Nicolas Shammas, MD, and the Midwest Cardiovascular Research
Foundation have published a prospective, multi-center, single-arm
investigation examining the use of the Auryon laser system in
patients with below-the-knee critical limb ischemia (CLI). The
study demonstrated that the Auryon laser system effectively reduced
residual stenosis to ≤30% in the majority of patients
post-treatment, without any cases of target lesion
revascularization6.
The recently published PATHFINDER registry further supports
these findings, showing no flow-limiting dissections and
significant improvement in Ankle-Brachial Index (ABI), Rutherford
classification, and Walking Impairment Questionnaires at both 6 and
12 months in a real-world clinical setting7.
These results add to a growing body of evidence indicating that
the Auryon laser system is a safe and effective treatment option
for a wide range of complex patients with PAD.
For important risk information, visit
www.auryon-system.com/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 walls1,3,8,9. The Auryon
Atherectomy System uses solid-state laser technology for the
treatment of PAD and is CE Marked with an indication for treatment,
including atherectomy, of infrainguinal stenoses and occlusions,
including ISR10,11. The Auryon System’s targeted biological
reactions minimize the risk of perforation and preserve the ability
to vaporize lesions without thermal ablation1,3,8,9. 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 pulses8. 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.
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.
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.
1 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-Laser IDE
study. Catheter Cardiovasc Interv. 2019;1-8. 2 Auryon System
Indications for Use 3 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-Laser , 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 4 Horváth, L., Németh, N.,
Fehér, G., Kívés, Z., Endrei, D., & Boncz, I. (2023).
Epidemiology of peripheral artery disease: Narrative review. Life,
13(6), 1257. https://pubmed.ncbi.nlm.nih.gov/35888129/ 5
AngioDynamics’ Canaccord Genuity 44th Annual Growth Conference
https://investors.angiodynamics.com/static-files/922d9caa-1088-4e4a-ba23-2f1486aa8817.
Published 2024. 6 Shammas NW, Yates T, Sastry A, Ricotta J, Beasley
R, Swee W, Torey JT, Shammas GA, Jones-Miller S, Corbet M.
Prospective, Multi-center, Single-Arm Study of the Auryon Laser
System for Treatment of Below-the-Knee Arteries in Patients With
Chronic Limb-Threatening Ischemia: 30-Day Results of the Auryon
BTK. Am J Cardiol. 2024 May 15;219:1-8. 7 Das TS, Shammas NW, Yoho
JA, Martinez-Clark P, Ramaiah V, Leon LR, Pacanowski JP, Tai Z, Ali
V, Arslan B, Rundback J. Solid state, pulsed-wave 355 nm UV laser
atherectomy debulking in the treatment of infrainguinal peripheral
arterial disease: The Pathfinder Registry. Catheter Cardiovasc
Interv. 2024 May;103(6):949-962. 8 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 9 Vogel A, Venugopalan
V. Mechanisms of pulsed laser ablation of biological tissues. Chem
Rev. 2003;103(2):577-644 10 Auryon System Indications for Use 11
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/20240903360421/en/
Investor Contact: Stephen Trowbridge Executive Vice
President & CFO 518-795-1408 strowbridge@angiodynamics.com
Media Contact: Saleem Cheeks Vice President,
Communications 518-795-1174 scheeks@angiodynamics.com
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