Inquis Medical announced today that it completed enrollment in a pivotal trial evaluating its Aventus thrombectomy system.
The FDA investigational device exemption (IDE) trial evaluates the safety and efficacy of Aventus for the treatment of pulmonary embolism (PE).
Aventus features proprietary tissue-sensing technology. It provides operators with real-time information on the tissue composition in contact with the device. The system offers enhanced precision and control during procedures, Inquis said in a news release. Last year, the system won FDA 510(k) clearance along with Inquis’ blood return system for peripheral indications. The company brought in a $40 million Series B funding round at the end of 2024 as well.
Investigators enrolled a total of 130 patients with intermediate-risk PE in the Aventus clinical trial. The multi-center, prospective, single-arm trial takes place across more than 20 prominent clinical sites across the U.S.
Dr. Jun Li, co-director of the Vascular Center and Pulmonary Embolism Response Team at University Hospitals Harrington Heart & Vascular Institute, serves as the trial’s national co-principal investigator. Li says Aventus offers unique, streamlined blood return, directional aspiration and the elimination of multiple dilator or wire exchanges.
“Completing enrollment in the Aventus pivotal study marks a significant milestone, highlighting the potential of the Aventus system to streamline and enhance treatment while underscoring Inquis Medical’s commitment to driving innovation and elevating standards of care in venous thromboembolic disease management,” said Mojgan Saadat, co-founder and co-CEO of Inquis Medical. “We sincerely thank the patients, investigators, and site clinical research staff for their efforts in bringing this trial to fruition.”
