AngioDynamics Launches Groundbreaking RECOVER-AV Trial

AngioDynamics Initiates the Innovative RECOVER-AV Clinical Trial

AngioDynamics, Inc. (NASDAQ: ANGO), recognized as a transformative leader in medical technology, has embarked on an important journey by launching the RECOVER-AV trial. This prospective, multicenter, multinational, single-arm clinical study aims to evaluate the safety, efficacy, and long-term functional outcomes related to the use of the AlphaVac F18?? System in treating acute pulmonary embolism (PE). The decision to implement this trial is grounded in AngioDynamics' commitment to developing solutions that restore healthy blood flow and enhance cancer treatment options for patients worldwide.

Purpose of the RECOVER-AV Trial

The primary focus of the RECOVER-AV trial is to assess the performance of the AlphaVac system as an effective treatment for patients facing intermediate-risk acute pulmonary embolism. The company is particularly targeting this clinical assessment to pave the way for the system's introduction into the European market, which has seen a rising incidence of PE incidents. By studying the process, AngioDynamics proactively aims to provide compelling clinical evidence of their device's efficacy.

This pivotal trial will follow the earlier APEX-AV study, which demonstrated that the AlphaVac F18?? System is not only safe but significantly fosters improvement in right ventricular function and reduces clot burden, thus enhancing patient outcomes. The insights from the RECOVER-AV trial are anticipated to strengthen the existing literature on the treatment modalities for PE.

Overview of the Clinical Study

The RECOVER-AV trial will enroll patients with confirmed intermediate-risk acute PE across approximately 20 hospital sites in Europe, showcasing a collaborative international effort. The primary efficacy endpoint will evaluate the changes in the right ventricular/left ventricular (RV/LV) ratio from baseline metrics at 48 hours following the procedure. Simultaneously, the study will monitor major adverse events (MAEs), with a focus on device-related deaths or major bleeding incidents occurring within a seven-day timeline. Patients will continue to be evaluated for functional outcomes at intervals of 30 days, six months, and one year.

Alleviating the Burden of Pulmonary Embolism

Estimates suggest that around 435,000 PE cases occur annually in the six major European Union countries. Data has shown that the prevalence of PE is notably higher in Europe than in the United States, where patients reaching emergency departments face greater acuity and worse outcomes. By initiating this clinical trial, AngioDynamics aims to clarify treatment efficacy and improve the overall management of acute PE in involved regions.

Laura Piccinini, the Senior Vice President and General Manager of Endovascular Therapies and International at AngioDynamics, emphasized the excitement surrounding this trial's launch. “We are eager to analyze the performance of the AlphaVac F18?? System in treating intermediate-risk pulmonary embolisms. Our collaborative efforts with clinical partners showcase our dedication to generating concrete clinical evidence worldwide,” she stated. This undertaking stands to solidify AngioDynamics’ role as a global leader in devising innovative medical solutions.

Regulatory Approval and Future Prospects

As a testament to its commitment to safe and effective treatment solutions, AngioDynamics received CE Mark approval for the AlphaVac F18?? System earlier this year, allowing the device for non-surgical thrombus removal from pulmonary arteries in the treatment of PE. This progress permits AngioDynamics to extend its influence in the European market, addressing an urgent need for optimized treatment protocols in the management of pulmonary embolism.

Leadership and Scientific Guidance

The RECOVER-AV study is being led by co-Principal Investigators, Erik Klok, MD, and Andrew Sharp, MD, both renowned experts in their respective fields. Their leadership is supported by an internationally respected Scientific Advisory Board, comprising experts who specialize in pulmonary embolism and related medical disciplines. This ensures that the study maintains high standards of excellence and relevance in its findings.

With significant backing from leading specialists across Europe, the trial seeks to develop robust protocols that can eventually enhance the clinical landscape of pulmonary embolism treatments.

About AngioDynamics, Inc.

AngioDynamics stands as a beacon in the realm of medical technology, committed to improving patient outcomes by focusing on vascular health and cancer treatment advancements. Through its innovative medical devices and technologies, the company seeks to address pressing patient needs and is consistently chosen by skilled physicians across expanding healthcare markets.

Frequently Asked Questions

What is the RECOVER-AV clinical trial about?

The RECOVER-AV clinical trial evaluates the safety and efficacy of the AlphaVac F18?? System for treating acute pulmonary embolism.

Who is conducting the RECOVER-AV trial?

The trial is led by co-Principal Investigators Erik Klok, MD, and Andrew Sharp, MD, alongside an international Scientific Advisory Board.

What are the primary endpoints of the trial?

The primary endpoints include the reduction of the RV/LV ratio from baseline and monitoring the incidence of major adverse events.

Where will the trial take place?

The trial will enroll participants across up to 20 hospital sites in Europe.

What is the significance of the AlphaVac F18?? System?

The AlphaVac F18?? System is designed for non-surgical removal of thrombi from pulmonary arteries, enhancing treatment options for patients affected by acute pulmonary embolism.

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