AngioDynamics Receives 510(k) Clearance for AlphaVac F18⁸⁵ System in Treatment of PE

Rhea-AI Summary

AngioDynamics, Inc. announces FDA clearance for AlphaVac F1885 System for the treatment of pulmonary embolism, enhancing patient care and safety. The system broadens treatment options, reduces thrombus burden, and improves right ventricular function. APEX-AV study results show significant reduction in RV/LV ratio and clot burden, with low MAEs rate.

Positive

• FDA clearance for AlphaVac F1885 System for pulmonary embolism treatment
• Enhanced patient care and safety with expanded treatment options
• Significant reduction in RV/LV ratio and clot burden shown in APEX-AV study
• Low rate of Major Adverse Events (MAEs) in APEX-AV study

Negative

• None.

Insights

Cardiologist

The FDA's clearance of the AlphaVac F1885 System for pulmonary embolism (PE) treatment is a significant development in the field of cardiovascular medicine. As a cardiologist, the introduction of new therapies like the AlphaVac System is promising, particularly considering the high prevalence and mortality rates associated with PE. The system's ability to reduce thrombus burden and improve right ventricular function could potentially lead to better patient outcomes and lower mortality rates.

Furthermore, the clinical trial data indicating a mean decrease in the RV/LV ratio and a low rate of Major Adverse Events (MAEs) suggest that the AlphaVac System could be a safer alternative to existing treatment modalities. This could influence treatment protocols and guidelines, leading to broader adoption of the device in clinical practice. The impact on the business side may be seen in increased demand for the device, potentially leading to higher sales and market share for AngioDynamics in the cardiovascular medical device sector.

Medical Device Analyst

The FDA clearance for the AlphaVac F1885 System represents a strategic milestone for AngioDynamics from a business perspective. The clearance not only broadens the utility of the device but also opens up a larger market segment for the company. Given the annual incidence of PE in the United States, the addressable market for this device is substantial.

From an investment standpoint, such regulatory advancements are closely monitored as they can significantly affect the company's revenue streams and growth trajectory. The successful completion of the APEX-AV study and the reported efficacy and safety outcomes are likely to resonate well with healthcare providers, potentially leading to rapid market penetration. However, it is important to monitor the post-market performance of the device as real-world data accumulates, which will further validate its clinical and economic value.

Healthcare Economist

The economic implications of the expanded FDA indication for the AlphaVac F1885 System are multifaceted. On one hand, the device offers the potential to reduce the overall cost burden of PE treatment by improving clinical outcomes and reducing the need for more invasive procedures. On the other hand, the acquisition and operating costs of the device itself will need to be evaluated against the cost savings from its clinical benefits.

It is essential to consider the long-term impact on healthcare spending. If the device can indeed lower the incidence of complications and readmissions, it may be cost-effective in the long run. Additionally, the company's focus on a patient outcome-driven solution aligns with the broader industry shift towards value-based care, which could favor the adoption of the AlphaVac System in healthcare systems focused on cost containment and quality of care.

New Indication for Treatment of Pulmonary Embolism Enhances Device Utility in Critical Medical Scenarios

LATHAM, N.Y.--(BUSINESS WIRE)-- 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 Consortium^TM, 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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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

Source: AngioDynamics, Inc.

FAQ

What is the FDA clearance announcement by AngioDynamics, Inc. regarding?

AngioDynamics, Inc. announced FDA clearance for the AlphaVac F1885 System for the treatment of pulmonary embolism (PE).

What is the significance of the FDA clearance for the AlphaVac F1885 System?

The FDA clearance enhances patient care and safety by broadening treatment options, reducing thrombus burden, and improving right ventricular function.

What were the primary endpoints of the APEX-AV study conducted by AngioDynamics?

The primary efficacy endpoint 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).

What were the key findings of the APEX-AV study regarding the AlphaVac F1885 System?

The study showed a significant mean decrease in the RV/LV ratio, a low rate of Major Adverse Events (MAEs), and a 35.5% mean reduction in clot burden.

Who were the co-Principal Investigators of the APEX-AV study?

The study was led by William Brent Keeling, MD, and Mona Ranade, MD.