Peer-reviewed data highlights successful
clinical study with 35.5% clot burden reduction, validating the
safety, efficacy, and efficiency of AlphaVac F1885 System in
pulmonary embolism treatment.
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
publication of the results from the Acute Pulmonary Embolism
Extraction Trial with the AlphaVac System (APEX-AV) in the Journal
of the Society for Cardiovascular Angiography & Interventions
(JSCAI). The article, “Novel Mechanical Aspiration Thrombectomy in
Patients with Acute Pulmonary Embolism: Results from the
Prospective APEX-AV Trial,” was published December 27, 2024.
Pulmonary embolism (PE), a potentially life-threatening
condition, affects approximately 900,000 individuals annually in
the United States, with 10-30% of cases resulting in death within
one month of diagnosis, according to the American Lung
Association.1
The primary efficacy endpoint of the APEX-AV trial was the
reduction in RV/LV ratio between baseline and 48 hours
post-procedure. The primary safety endpoint was the rate of 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 results demonstrated the device as a
safe and effective treatment for acute intermediate-risk PE with a
significant reduction in RV/LV ratio and clot burden with a low
rate of adverse events.
The APEX-AV trial demonstrated a 35.5% reduction in clot burden
(via the Modified Miller index score), comparing favorably to other
mechanical aspiration devices on the market.2 The unique design
features of the device, including its funnel tip, optional wireless
navigation, and blood loss mitigation, contributed to clinically
significant improvements in both safety and efficacy.
"Achieving publication in a respected, peer-reviewed journal
underscores the strength and importance of the APEX-AV trial
findings and their potential impact on patient outcomes," said Juan
Carlos Serna, AngioDynamics Senior Vice President of Scientific and
Clinical Affairs. "The inclusion of the AlphaVac F1885 System in
JSCAI validates our commitment to advancing meaningful solutions
for pulmonary embolism, a life-threatening condition affecting
hundreds of thousands of people each year. This milestone caps a
transformative year for the AlphaVac F1885 System, following its
FDA clearance for PE thrombectomy and its spotlight at the SCAI
Scientific Sessions. We are proud to deliver innovations that equip
physicians with effective tools to improve care and save
lives."
The APEX-AV trial was initiated in partnership with the widely
respected Pulmonary Embolism Response Team (PERT) Consortium™ and
was led by co-Principal Investigators William Brent Keeling, MD,
Associate Professor at the Emory School of Medicine in Atlanta,
Georgia, and Mona Ranade, MD, Assistant Professor, Interventional
Radiology, at the David Geffen School of Medicine at UCLA. The
trial results were initially presented at The Society for
Cardiovascular Angiography & Interventions (SCAI) 2024
Scientific Sessions hosted in Long Beach, California in May.
“We are incredibly excited by the results of the APEX-AV trial,
which demonstrate the safety and efficacy of the AlphaVac F1885
System in treating patients with pulmonary embolism,” said 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™. “These outcomes are critical
for PE patients, where timely and efficient intervention can
greatly improve long-term health outcomes and reduce the risk of
complications.”
In December 2023, AngioDynamics announced the completion of
patient enrollment in its APEX-AV trial, 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. In April 2024, the United States Food and Drug
Administration (FDA) cleared the AlphaVac F1885 System for the
treatment of PE.
“The results from the APEX-AV trial demonstrate the significant
impact of the AlphaVac F1885 technology in treating pulmonary
embolism,” said Mona Ranade, MD, Assistant Professor,
Interventional Radiology, at the David Geffen School of Medicine at
UCLA. “We observed a significant reduction in clot burden pre- and
post-treatment, and saw a notable improvement in pulmonary artery
pressures, underscoring the efficacy of this innovative approach.
The procedure was completed with remarkable efficiency, with a
short procedure time, making it a promising option for patients in
need of rapid and effective intervention.”
The published article concluded that “Percutaneous mechanical
aspiration thrombectomy with the AlphaVac system provided a safe
and effective treatment for acute intermediate-risk PE with a
significant reduction in RV/LV ratio and clot burden with a low
rate of adverse events.”
JSCAI publishes original research, comprehensive reviews,
meta-analyses, study designs, society guidelines, editorials,
research letters, case reports, and images. The subject matter
includes all interventional subspecialities including coronary,
peripheral, structural, and congenital heart disease.
To access the published material, visit:
https://www.sciencedirect.com/science/article/pii/S2772930324021525.
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 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
https://ihpi.umich.edu/news/pulmonary-embolism-deaths-disparities-high-despite-advancements-care
2
https://www.sciencedirect.com/science/article/pii/S2772930324021525
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version on businesswire.com: https://www.businesswire.com/news/home/20250113630480/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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