New Indication for Treatment of Pulmonary
Embolism Enhances Device Utility in Critical Medical Scenarios
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
AlphaVac F1885 System for the treatment of pulmonary embolism (PE),
enhancing its utility in critical medical scenarios such as PE.
PE affects around 900,000 people in the United States every year
and is the third leading cause of cardiovascular mortality in the
nation.1,2 Patients with sub-massive or intermediate-risk PE
account for 35% to 55% of hospitalized patients with PE and have a
mortality rate of 3% to 14%.2,3
The expanded FDA indication allows for the utilization of the
AlphaVac F1885 System for the treatment of PE, which broadens the
applicability of the AlphaVac F1885 System in the non-surgical
removal of thrombi or emboli from the venous vasculature. The
indication expands treatment options for patients with PE, reducing
thrombus burden and improving right ventricular function.
“FDA clearance marks a significant advancement in patient care
and safety. This milestone underscores our commitment to merging
physician-centric design with patient outcome-driven solutions,”
said Juan Carlos Serna, AngioDynamics Senior Vice President of
Scientific and Clinical Affairs. “In addition to meeting our
primary endpoints, the trial also showed a meaningful, favorable
reduction in clot burden, ultimately improving patient
outcomes.”
In December 2023, AngioDynamics announced the completion of
patient enrollment in its 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 in the United States to assess the AlphaVac F18⁸⁵ System for
the treatment of PE.
The APEX-AV study was initiated in partnership with the widely
respected Pulmonary Embolism Response Team (PERT) Consortium™ and
led by co-Principal Investigators William Brent Keeling, MD,
Associate Professor of Surgery, Department of Surgery, at the Emory
University School of Medicine, and Immediate Past President, The
PERT Consortium™ and Mona Ranade, MD, Assistant Professor,
Interventional Radiology, at the David Geffen School of Medicine at
UCLA.
“The addition of the AlphaVac System in the mechanical
thrombectomy world is a critical step forward in the treatment of
PE patients,” said Dr. Keeling. “The rapid patient enrollment and
the excellent safety and efficacy outcomes from the APEX-AV study
validate the need for such technologies to be part of the PE
treatment algorithm.”
The primary efficacy endpoint of the APEX-AV Study was the
reduction in RV/LV ratio between baseline and 48 hours
post-procedure. The primary safety endpoint was the rate of Major
Adverse Events (MAEs), including events such as major bleeding and
serious device-related clinical deterioration, pulmonary vascular
injury, and cardiac injury, within the first 48 hours. Patients
were followed for 30 days post-index procedure.
“The 510(k) clearance of the AlphaVac System represents an
important milestone towards the treatment of PE,” said Mona Ranade,
MD, Assistant Professor, Interventional Radiology, at the David
Geffen School of Medicine at UCLA. “The data from the APEX-AV study
showed a significant improvement in the RV function and a rapid
resolution of clot burden in the pulmonary arteries.”
The APEX-AV Study 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
MAEs 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-procedure.4
“Catheter-based therapies are becoming a major tool in the PE
space,” said John M. Moriarty, MD, President-elect, The PERT
ConsortiumTM, Professor, Interventional Radiology, UCLA. “With a
handle that can limit blood loss and a true large bore cannula with
a 33 Fr funnel, I expect the AlphaVac System to play a crucial role
in the treatment of PE.”
About the AlphaVac F1885 System
The AlphaVac F1885 System is an emergent first-line device that
is currently cleared for the removal of thromboemboli from the
venous system 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 for a clearance specific to PE.
For risk information, visit https://bit.ly/Angio-risk-info.
About The PERT Consortium™
The purpose of The PERT Consortium™ is to serve the general
public by undertaking activities to advance the status of PE care
and promote research in the treatment of PE. Specifically, the
Consortium’s purpose is to:
Promote the adoption of the PERT model in healthcare
institutions across the United States to ensure the prompt
diagnosis and treatment of PE.
Expand the current body of scientific literature on the
diagnosis and treatment of PE through the funding of scientific
endeavors.
Educate the general public and healthcare professionals
regarding PE diagnosis, treatment and care.
By focusing solely on the entirety of PE – its etiology,
pathophysiology, prevention, management approach, outcomes of
specific treatments and follow-up pathways – it is the intention of
the Consortium to increase awareness of treatment options available
to patients with PE, to reduce its incidence worldwide, to improve
health outcomes and to positively influence the impact of this
terrible disease.
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 Learn About Pulmonary Embolism. Lung.org.
http://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism.
Published 2023.
2 Giri J, Sista AK, Weinberg I, et al. Interventional Therapies
for Acute Pulmonary Embolism: Current Status and Principles for The
Development Of Novel Evidence: A Scientific Statement From The
American Heart Association. Circulation 2019;140(20)e774-e801.
3 Machanahalli Balakrishna A, Reddi V, Belford PM, Alvarez M,
Jaber WA, Zhao DX, Vallabhajosyula S. Intermediate-Risk Pulmonary
Embolism: A Review of Contemporary Diagnosis, Risk Stratification
and Management. Medicina (Kaunas). 2022 Aug 30;58(9):1186.
4 Data on file.
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version on businesswire.com: https://www.businesswire.com/news/home/20240404798384/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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