Inquis Medical announced the completion of patient enrollment in its AVENTUS Clinical Trial, a pivotal Investigational Device Exemption (IDE) trial assessing the safety and efficacy of the Aventus Thrombectomy System for treating pulmonary embolism (PE). The trial, conducted across more than 20 sites in the United States, enrolled a total of 130 patients with intermediate-risk PE.
The AVENTUS system incorporates streamlined blood return, directional aspiration, and eliminates the need for multiple dilator or wire exchanges. According to Inquis Medical, this combination offers an efficient solution for removing thrombi in PE patients. Current lytic-free aspiration thrombectomy procedures can face limitations, including significant blood loss and procedural inefficiencies. The Aventus system also won FDA 510(k) clearance last year along with Inquis’ blood return system for peripheral indications.
Expert Commentary
"This trial is a key step toward delivering a more streamlined, efficient, and precise thrombectomy solution for treating life-threatening blood clots," said Dr. Jun Li, Co-Director of the Vascular Center and Pulmonary Embolism Response Team at University Hospitals Harrington Heart & Vascular Institute and the trial’s National Co-Principal Investigator (PI). Dr. Saher Sabri, Professor of Radiology at Georgetown University School of Medicine and National Co-Principal Investigator, added, "The AVENTUS pivotal trial represents a new option for treating pulmonary embolism."
Venous Thromboembolism (VTE) Burden
In the United States, up to 900,000 individuals are affected by venous thromboembolism (VTE) annually. Over 50% of deep vein thrombosis cases progress to pulmonary embolism (PE), which is the third leading cause of cardiovascular death. Inquis Medical aims to address the limitations of current treatments and redefine the standard of care in this field.
About the AVENTUS System
The Aventus system features proprietary tissue-sensing technology. It provides operators with real-time information on the tissue composition in contact with the device, offering enhanced precision and control during procedures.
