122 Patients Enrolled in Single-arm IDE
Study; 30-Day Follow-up
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
completion of patient enrollment in the Acute Pulmonary Embolism
Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a
clinical study aimed at evaluating the safety and efficacy of the
Company’s AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885
System in the treatment of acute intermediate-risk pulmonary
embolism (PE).
PE represents the third-leading cause of cardiovascular
mortality in the United States.1
“The completion of the APEX-AV Study to assess the performance
of the AlphaVac F1885 System in reducing thrombus burden and
improving right ventricular function is a meaningful step toward
expanding treatment options and improving care for patients with
pulmonary embolism,” said Juan Carlos Serna, AngioDynamics’ Senior
Vice President of Clinical and Scientific Affairs. “We thank The
PERT Consortium™, including our enrolling partners, for its
commitment to generating robust clinical evidence to help address
the needs of this patient population.”
APEX-AV is 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. The primary
efficacy endpoint of the APEX-AV Study is the reduction in RV/LV
ratio between baseline and 48 hours post-procedure. The primary
safety endpoint is the rate of Major Adverse Events (MAEs),
including device-related death and major bleeding within the first
48 hours. Patients will be followed for 30 days post-index
procedure.
“The completion of the APEX-AV Study represents an important
milestone in the catheter-directed therapies CDT space for the
treatment of pulmonary embolism. I sincerely thank all the
investigators for their commitment and dedication,” 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™.
AngioDynamics initiated the APEX-AV Study in partnership with
the widely respected Pulmonary Embolism Response Team (PERT)
Consortium™. The study is 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.
“Data from the APEX-AV study expands the current body of
literature on the safety and efficacy of mechanical thrombectomy
and broadens the PE treatment options, particularly in this space,”
said Mona Ranade, MD, Assistant Professor, Interventional
Radiology, at the David Geffen School of Medicine at UCLA.
Pulmonary embolism (PE) can be a life-threatening condition that
affects around 900,000 people in the United States every year.2 In
most cases, PE is caused by blood clots in the legs, called deep
vein thrombosis, that travel to the lungs.2 Patients with
submassive or intermediate-risk PE account for 35% to 55% of
hospitalized patients with PE and have a mortality rate of 3 to
14%.1,3
Visit https://clinicaltrials.gov/ct2/show/NCT05318092 for more
information about the APEX-AV Study.
About the AlphaVac MMA F1885 System
The AlphaVac MMA F1885 System is an emergent first-line device
that is currently cleared for the removal of thromboemboli from the
venous system. 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.
The AlphaVac MMA F1885 System, when used for treatment of
pulmonary embolism, is an investigational device, limited by United
States law to investigational use.
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 entity 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 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.
2 Learn About Pulmonary Embolism. Lung.org.
http://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism.
Published 2023.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231207708613/en/
Investor Relations Contact: Stephen Trowbridge
518-795-1408 strowbridge@angiodynamics.com
Media Contact: Saleem Cheeks 518-795-1174
scheeks@angiodynamics.com
AngioDynamics (NASDAQ:ANGO)
Historical Stock Chart
From Apr 2024 to May 2024
AngioDynamics (NASDAQ:ANGO)
Historical Stock Chart
From May 2023 to May 2024