AngioDynamics has launched the RECOVER-AV clinical trial of its AlphaVac Multipurpose Mechanical Aspiration (MMA) F18⁸⁵ System in patients with acute pulmonary embolism (PE).
According to the US-based medical technology company, the prospective, multicentre, multinational study will assess the efficacy, safety, and long-term functional outcomes of the system in treating the condition.
The trial will evaluate the device’s ability to treat intermediate-risk PE through percutaneous mechanical aspiration thrombectomy, with the aim of facilitating its adoption in Europe.
The RECOVER-AV study follows the completion of the APEX-AV (Acute Pulmonary Extraction Trial with AlphaVac), a previous single-arm trial conducted in the US under an Investigational Device Exemption.
The APEX-AV trial enrolled 122 patients with confirmed intermediate-risk PE. Results from the study demonstrated that the AlphaVac F18⁸⁵ System was safe for patients, significantly improving right ventricular function and reducing clot burden.
In the RECOVER-AV trial, patients with confirmed intermediate-risk PE will be enrolled across up to 20 hospital sites in Europe. The primary efficacy endpoint will be the reduction in the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours after the procedure.
The trial will also focus on safety, with the primary endpoint being the incidence of major adverse events (MAEs), such as device-related deaths or significant bleeding, occurring within seven days of the procedure. To further assess long-term outcomes, patients will be followed for 12 months, with functional health monitored at 30 days, six months, and one year.
AngioDynamics senior vice president and endovascular therapies and international general manager Laura Piccinini said: “We are excited to launch this important trial as we assess the performance of the AlphaVac F18⁸⁵ System in patients with intermediate-risk pulmonary embolisms.
“With our clinical partners, we are demonstrating our continued commitment to generating robust clinical evidence across the world. This is the first international study we have sponsored, highlighting our dedication as a global leader in advancing care and treating more patients.”
In May, AngioDynamics announced that the AlphaVac F18⁸⁵ System had received CE Mark approval in Europe for the non-surgical removal of thrombi or emboli from the pulmonary arteries, specifically for the treatment of pulmonary embolism.
Recently, AngioDynamics received European CE Mark approval for its Auryon Atherectomy System. The laser system has been approved to treat peripheral artery disease (PAD), including critical limb ischemia (CLI) and in-stent restenosis (ISR).
