Inquis Medical’s AVENTUS Thrombectomy System Earns Expanded FDA Clearance

The U.S. Food and Drug Administration (FDA) has granted an expanded 510(k) clearance to Inquis Medical’s AVENTUS Thrombectomy System for treating 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,” Inquis Medical Co-CEO  Vahid Saadat said. “It validates the efforts of our team and the partnerships we’ve built with our physicians, all focused on solving long-standing challenges in clot removal. AVENTUS is designed to meet the needs of physicians treating this life-threatening condition quickly, effectively, and safely.”

The AVENTUS Thrombectomy System incorporates proprietary tissue-sensing technology to help operators distinguish the type of tissue in contact with the catheter tip in real time and guide precise clot removal; it 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,” Inquis Medical Co-CEO  Mojgan Saadat stated. “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 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 U.S. 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 and were simultaneously published in the society’s journal, JSCAI.

Inquis Medical is a medical device company focused on peripheral vascular innovations. The company is developing next-generation thrombectomy technology that provides physicians with improved control and precision, enhances procedural efficiency, and minimizes blood loss. Founded in 2020, Inquis Medical is led by an executive team with decades of experience in developing, launching, and supporting medical devices that address unmet clinical needs and deliver lasting impact.