New data finds AlphaVac F1885 System safe in
patients with acute intermediate-risk pulmonary embolism (PE) and
provides significant improvement in right ventricular function and
reduction in clot burden
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 results
from the Acute Pulmonary Embolism Extraction Trial with the
AlphaVac System (APEX-AV) were presented at The Society for
Cardiovascular Angiography & Interventions (SCAI) 2024
Scientific Sessions hosted in Long Beach, California on May 3,
2024.
Co-Principal Investigator 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™, gave a presentation titled “Evaluating the safety
and efficacy of the AlphaVac F1885 System in acute intermediate
risk PE patients: APEX-AV trial” as part of the of the featured
clinical research session.
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 (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-procedure1 and a mean procedure time of 37.2
minutes.1
“The impressive reduction in clot burden, in addition to the
safety and efficacy results observed in the APEX-AV trial,
underscore the importance of integrating this technology into the
treatment of acute PE,” said Dr. Keeling. “Pulmonary emboli can be
extremely dangerous and require effective and prompt action. We
thank SCAI for the opportunity to share the study findings in
detail.”
PE affects approximately 900,000 people in the United States
every year and is the third leading cause of cardiovascular
mortality in the nation.2,3 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%.3,4
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 of the trial highlight the unique features of the
AlphaVac device,” said Juan Carlos Serna, AngioDynamics Senior Vice
President of Scientific and Clinical Affairs. “The reduction in
clot burden of 35.5% compares favorably to the 9.3% reduction
reported in the current market leader’s IDE data. The mean
procedure time was 37 minutes compared to 57 minutes as reported by
the current market leader. These results were achieved while
maintaining a clinically equivalent primary efficacy and safety
comparison.”1,5,6
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,
and Mona Ranade, MD, Assistant Professor, Interventional Radiology,
at the David Geffen School of Medicine at UCLA.
“After demonstrating safety and effectiveness in patients, the
FDA clearance of AlphaVac 1885 System for PE thrombectomy marks a
significant milestone in interventional medicine,” said Mona
Ranade, MD, Assistant Professor, Interventional Radiology, at the
David Geffen School of Medicine at UCLA. "The innovative system's
overall ease of use with its steerable cannula and ability to
navigate without a wire between the pulmonary arteries promises to
enhance patient outcomes by providing a minimally invasive solution
to a critical medical challenge and demonstrates a commitment to
advancing cardiovascular care."
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.
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 SCAI
The Society for Cardiovascular Angiography & Interventions
(SCAI) is the leading nonprofit medical society representing
invasive and interventional cardiology. Founded in 1978, SCAI’s
mission is to lead the global interventional cardiovascular
community through education, advocacy, research, and quality
patient care.
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 Data on file. 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 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. 4 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. 5 The comparisons reported here are from
two separate trials and not a head to head comparison. The FLARE
trial (FlowTriever Pulmonary Embolectomy Clinical Study) was a
prospective, single-arm, multicenter investigational device
exemption trial in which patients with acute intermediate-risk PE
were treated with the FlowTriever Retrieval/Aspiration System
(Inari Medical, Irvine, California). 6 Tu T, Toma C, Tapson VF,
Adams C, Jaber WA, Silver M, Khandhar S, Amin R, Weinberg M,
Engelhardt T, Hunter M, Holmes D, Hoots G, Hamdalla H, Maholic RL,
Lilly SM, Ouriel K, Rosenfield K; FLARE Investigators. A
Prospective, Single-Arm, Multicenter Trial of Catheter-Directed
Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary
Embolism: The FLARE Study. JACC Cardiovasc Interv. 2019 May
13;12(9):859-869.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240506582349/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
AngioDynamics (NASDAQ:ANGO)
Historical Stock Chart
From Apr 2024 to May 2024
AngioDynamics (NASDAQ:ANGO)
Historical Stock Chart
From May 2023 to May 2024