Inquis Medical has announced that its Aventus thrombectomy system has received 510(k) clearance from the US Food and Drug Administration (FDA) for an expanded indication to treat pulmonary embolism (PE).
The Aventus System is a next-generation mechanical thrombectomy platform developed in close collaboration with physicians to address critical limitations of current technologies.
“The FDA’s clearance of the Aventus system marks a major milestone for the company,” said Vahid Saadat, co-CEO of Inquis Medical. “It validates the tireless efforts of our team and the deep partnerships we’ve built with our physicians, all focused on solving long-standing challenges in clot removal. Aventus is uniquely designed to meet the needs of physicians treating this life-threatening condition quickly, effectively, and safely.”
The Aventus thrombectomy system was previously cleared by the FDA for use in the peripheral vasculature. Additionally, 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. This most recent clearance extends the platform’s indication to include the treatment of pulmonary embolism.
“Treating PE requires both speed and precision,” said Mojgan Saadat, co-CEO of Inquis Medical. “The Aventus platform is the only thrombectomy solution with integrated tissue-sensing technology that enables precision removal of large clot burdens while streamlining blood return and reducing procedural complexity, all in a single, integrated approach. Receiving this clearance in record time speaks to the strength of our clinical data, the quality of our regulatory submission, and the incredible work of the Inquis team. We’re thrilled to launch this technology and deliver a state-of-the-art solution to physicians on the front lines of saving lives.”
This regulatory milestone follows the successful completion of the AVENTUS pivotal trial, the first US investigational device exemption (IDE) study to evaluate aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE patients.
The trial demonstrated excellent safety and performance across a broad range of clinical settings, with no device-related major adverse events and rapid improvement in right heart strain. The results were presented as a late-breaking clinical trial at the 2025 Society of Cardiovascular Angiography and Interventions (SCAI) scientific sessions (1–3 May, Washington, DC, USA) and were simultaneously published in JSCAI.
