AngioDynamics Receives 510(k) Clearance for AlphaVac F18⁸⁵ System in Treatment of PE
New Indication for Treatment of Pulmonary Embolism Enhances Device Utility in Critical Medical Scenarios
PE affects around 900,000 people in
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
In
The APEX-AV study was initiated in partnership with the widely respected
“The addition of the AlphaVac System in the mechanical thrombectomy world is a critical step forward in the treatment of PE patients,” said
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
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
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
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
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
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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240404798384/en/
Investors:
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com
Media:
Vice President, Communications
518-795-1174
scheeks@angiodynamics.com
Source: