Inquis Medical has announced completion of patient enrolment in its AVENTUS clinical trial, a pivotal investigational device exemption (IDE) trial evaluating the safety and efficacy of the company’s Aventus thrombectomy system for the treatment of pulmonary embolism (PE).
A total of 130 patients with intermediate-risk PE were enrolled in the AVENTUS clinical trial, a multicentre, prospective, single-arm trial conducted at more than 20 clinical sites across the USA.
“This trial is a key step toward delivering a more streamlined, efficient, and precise thrombectomy solution for treating life-threatening blood clots,” said Jun Li, co-director of the Vascular Center and Pulmonary Embolism Response Team at University Hospitals Harrington Heart & Vascular Institute (Cleveland, USA) and the trial’s national co-principal investigator (PI). “The AVENTUS system stands out with its unique combination of streamlined blood return, directional aspiration, and the elimination of multiple dilator or wire exchanges, offering an elegant and efficient solution for removing thrombi in PE patients.”
“The AVENTUS pivotal trial represents a new option for treating pulmonary embolism,” said the trial’s national co-principal investigator, Saher Sabri, professor of Radiology at Georgetown University School of Medicine, Chief of Interventional Radiology at MedStar Health, and Division Chief of Interventional Radiology at MedStar Georgetown University Hospital (Washington, DC, USA). “We are grateful to the 130 patient volunteers in this trial and to our colleagues who helped rapidly enrol participants reflecting the clinical community’s strong dedication to advancing care in this field.”
“Completing enrolment 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.”
