Multi-center, multi-national study to
evaluate mechanical thrombectomy treatment in acute,
intermediate-risk PE patients 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 the launch
of the Prospective, Multicenter, Multi-national, Single Arm Trial
Evaluating the Efficacy, Safety and long term functional outcomes
of percutaneous mechanical aspiration thrombectomy for Treatment of
Acute Pulmonary Embolism (PE) using the AlphaVac Multipurpose
Mechanical Aspiration (MMA) F1885 System (RECOVER-AV).
The RECOVER-AV trial is designed to evaluate the safety and
efficacy of AlphaVac for the treatment of acute, intermediate-risk
PE to support its adoption in the European market.
This study follows the Acute Pulmonary Extraction Trial with
AlphaVac (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 in the United
States to assess the AlphaVac F18⁸⁵ System for the treatment of PE.
APEX-AV, which completed enrollment in December 2023, demonstrated
that the AlphaVac F1885 System is safe in patients with acute
intermediate-risk PE and provides significant improvement in right
ventricular function and reduction in clot burden.
The RECOVER-AV study is a multi-center, multi-national trial
enrolling patients with confirmed acute, intermediate-risk PE
across up to 20 hospital sites in Europe. The primary efficacy
endpoint is the reduction of the right ventricular/left ventricular
(RV/LV) ratio from baseline to 48 hours post-procedure. The primary
safety endpoint focuses on the incidence of Major Adverse Events
(MAEs), such as device-related death or major bleeding within seven
days. Patients will be followed for 12-months, with functional
outcomes assessed at 30-days, six-months, and 12-months.
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
“We are excited to launch this important trial as we assess the
performance of the AlphaVac F1885 System in patients with
intermediate-risk pulmonary embolisms,” said Laura Piccinini,
AngioDynamics Senior Vice President and General Manager of
Endovascular Therapies and International. “With our clinical
partners, we are demonstrating our continued commitment to
generating robust clinical evidence across the world, with this
being the first international study we have sponsored highlighting
our commitment as a global leader to treat more patients and
advance care.”
In May, the Company announced that its AlphaVac F1885 System
received CE Mark approval in Europe for the non-surgical removal of
thrombi or emboli from pulmonary arteries, including for treating
PE. This approval allows the Company to expand its reach in the
European market, where PE prevalence is notably higher than in the
U.S.2 The AlphaVac F1885 System is designed to enhance treatment
options for healthcare professionals and improve outcomes for
patients suffering from PE.
The Study is led by co-Principal Investigators Erik Klok, MD,
Professor of Medicine and Vascular Medicine Specialist at Leiden
University Medical Center, and Andrew Sharp, MD, Professor of
Interventional Cardiology at Mater Misericordiae Hospital and
University College Dublin.
They are supported by an internationally renowned Scientific
Advisory Board featuring leading experts in pulmonary embolism (PE)
and related fields, including Prof. Menno Huisman (Leiden UMC,
Netherlands), John Moriarty, MD (UCLA, USA), Prof. Makis Avgerinos
(University of Athens, Greece), Prof. Irene Lang (Medical
University of Vienna, Austria), Julie Helms, MD (CHRU Strasbourg,
France), and Sebastian Stefaniak, MD, and Mateusz Puslecki, MD
(PUMS, Poland).
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. 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, 2024. 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
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version on businesswire.com: https://www.businesswire.com/news/home/20240919696998/en/
Investor: Stephen Trowbridge Executive Vice President
& CFO 518-795-1408 strowbridge@angiodynamics.com
Media: Saleem Cheeks Vice President, Communications
518-795-1174 scheeks@angiodynamics.com
AngioDynamics (NASDAQ:ANGO)
過去 株価チャート
から 10 2024 まで 11 2024
AngioDynamics (NASDAQ:ANGO)
過去 株価チャート
から 11 2023 まで 11 2024
