Inquis’ Aventus Thrombectomy System Cleared to Treat PE

June 16, 2025—Inquis Medical announced that its Aventus mechanical thrombectomy system has received FDA 510(k) clearance for an expanded indication to treat pulmonary embolism (PE). The device was previously cleared by the FDA for use in the peripheral vasculature.

According to Inquis, the Aventus system incorporates the company’s tissue-sensing technology to help physicians distinguish the type of tissue in contact with the catheter tip in real time and guide precise clot removal.

Additionally, the company noted that the Aventus clot management system received FDA clearance for use with the Aventus thrombectomy system to enable autologous blood transfusion, allowing reinfusion of filtered aspirated blood and supporting efficient blood-conserving clot removal. The recent clearance extends the platform’s indication to include the treatment of PE.

The company advised that the regulatory clearance comes after the completion of the AVENTUS pivotal trial, which evaluated aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE patients. The trial met its primary endpoints, demonstrating the system’s safety and performance across a broad range of clinical settings with no device-related major adverse events and rapid improvement in right heart strain, noted Inquis.

In May, Inquis Medical announced that the findings from the AVENTUS trial were presented by Jun Li, MD, at the SCAI 2025 scientific sessions and were simultaneously published by Saher Sabri, MD, et al in JSCAI.