AngioDynamics, Inc. (NASDAQ: ANGO), a leading medical technology company dedicated to enhancing vascular health and expanding cancer treatment options, has announced the launch of the RECOVER-AV trial. This prospective, multicenter, multinational, single-arm study will evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy for treating acute pulmonary embolism (PE) using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System.
The RECOVER-AV trial aims to assess the safety and efficacy of the AlphaVac system for treating acute, intermediate-risk pulmonary embolism (PE), supporting its adoption in the European market.
This study follows the APEX-AV trial, which enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 U.S. sites. APEX-AV demonstrated that the AlphaVac F1885 System is safe and significantly improves right ventricular function while reducing clot burden.
RECOVER-AV is a multicenter, multinational trial enrolling patients with confirmed acute, intermediate-risk PE at up to 20 hospital sites in Europe. The primary efficacy endpoint is the reduction of the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure. The primary safety endpoint focuses on the incidence of major adverse events (MAEs), including device-related death or major bleeding within seven days. Patients will be followed for 12 months, with functional outcomes assessed at 30 days, six months, and 12 months.
With an estimated 435,000 PE events annually in the six largest EU countries, the prevalence is notably higher than in the U.S., with European patients experiencing greater acuity and worse outcomes.
“We are excited to launch this important trial as we evaluate the AlphaVac F1885 System’s performance in patients with intermediate-risk pulmonary embolisms,” said Laura Piccinini, Senior VP and General Manager of Endovascular Therapies and International at AngioDynamics. “This international study underscores our commitment to generating robust clinical evidence and advancing care globally.”
In May, the AlphaVac F1885 System received CE Mark approval in Europe for the non-surgical removal of thrombi from pulmonary arteries, facilitating the company’s expansion in a region with a high prevalence of PE. The system aims to enhance treatment options and improve outcomes for patients suffering from PE.
The study is led by co-principal investigators Erik Klok, MD, and Andrew Sharp, MD, supported by an internationally recognized Scientific Advisory Board of experts in pulmonary embolism and related fields.
About the AlphaVac F1885 System
The AlphaVac F1885 System is designed for the non-surgical removal of thromboemboli from the pulmonary arteries. It includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly.
About AngioDynamics, Inc.
AngioDynamics is a transformative medical technology company focused on restoring healthy blood flow, expanding cancer treatment options, and improving patient quality of life.
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