Regulatory approval enables entry of
AlphaVac Mechanical Thrombectomy 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 AlphaVac F1885 System for the non-surgical
removal of thrombi or emboli from the pulmonary arteries and for
the treatment of pulmonary embolism (PE).
“The CE Mark represents a major step forward in enhancing
patient care and safety for endovascular therapies in the EU, a
market with a higher prevalence of PE when compared to the United
States,” said Laura Piccinini, AngioDynamics Senior Vice
President/General Manager, Endovascular Therapies and
International. “This designation allows us to broaden our reach and
provide innovative solutions to more healthcare professionals
treating patients diagnosed with PE – on an increasingly global
scale.”
An estimated 435,000 PE events occur each year in the six
largest European Union (EU) countries.1 Compared to the United
States, the prevalence of PE is higher for those patients admitted
to the emergency department in Europe, and European patients also
had higher acuity and worse outcomes.2
The CE Mark for the AlphaVac F1885 System expands treatment
options for healthcare professionals in the EU by offering a tool
that helps reduce thrombus burden and improve right ventricular
function in patients with PE.
In December 2023, AngioDynamics announced the completion of
patient enrollment in its United States-based Acute Pulmonary
Embolism Extraction Trial with the AlphaVac System (APEX-AV) study,
a single-arm Investigational Device Exemption study that enrolled
122 patients with confirmed acute, intermediate-risk PE across 25
hospital-based sites to assess the AlphaVac F18⁸⁵ System for the
treatment of PE.
The APEX-AV trial showed a mean decrease in the RV/LV ratio from
baseline to 48 hours post-procedure of 0.45 (significantly greater
than the pre-defined performance goal of 0.12 (p < 0.001)) and a
Major Adverse Event (MAE) rate of 4.1% (significantly lower than
the pre-defined performance goal of 25% (p < 0.001)). The study
also showed a 35.5% mean reduction in clot burden from baseline to
48 hours post-procedure3 and a mean procedure time of 37.2
minutes.3
About the AlphaVac F1885 System
The AlphaVac F1885 System is an emergent first-line device that
is currently CE marked for the non-surgical removal of
thromboemboli from the pulmonary arteries and for the treatment of
PE. The System includes an ergonomic handle, an 18F cannula with an
85-degree angle, an obturator, and a waste bag assembly. The
APEX-AV Study was designed to provide safety and efficacy data
specific to PE. For risk information, visit
https://bit.ly/Angio-risk-info.
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 AlphaVac are
trademarks and/or registered trademarks of AngioDynamics, Inc., an
affiliate or subsidiary. All other trademarks are property of their
respective owners.
1 Willich SN, Chuang LH, van Hout B, Gumbs P, Jimenez D, Kroep
S, Bauersachs R, Monreal M, Agnelli G, Cohen A. Pulmonary embolism
in Europe - Burden of illness in relationship to healthcare
resource utilization and return to work. Thromb Res. 2018
Oct;170:181-191. 2 Germini F., Zarabi S., Eventov M., Turcotte M.,
Li M., de Wit K. Pulmonary embolism prevalence among emergency
department cohorts: A systematic review and meta‐analysis by
country of study. Journal of Thrombosis and Haemostasis. 2022 Dec;
19(1):173-185 3 Data on file.
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version on businesswire.com: https://www.businesswire.com/news/home/20240521113985/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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