Study: Inquis Medical’s AVENTUS Thrombectomy System Effectively Treats PE

Inquis Medical is touting positive AVENTUS Trial results that demonstrate the efficacy of its thrombectomy solution to safely treat acute intermediate-risk pulmonary embolisms.

The AVENTUS study evaluated the safety and efficacy of the company’s AVENTUS Thrombectomy System. Results—“A Prospective Study of the Next Generation AVENTUS Thrombectomy System: Advancing Thrombectomy and Autologous Blood Reinfusion for Pulmonary Embolism”—were also published in the Society of Cardiovascular Angiography and Interventions’ peer-reviewed journal, JSCAI.

The AVENTUS Trial successfully met its primary endpoints, demonstrating both safety and efficacy in treating acute intermediate-risk pulmonary embolism (PE) patients. Results showed significant improvement in right ventricular (RV) function, reduction in clot burden, minimal blood loss, and short ICU and total hospital stays with no device related major adverse events. The trial also reported meaningful improvements in patient-reported quality of life and a significant increase in six-minute walk test (6MWT) distance through 30 days.

“There remains a clear need for next-generation technologies that can address some of the limitations of current PE devices,” 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. “The AVENTUS Trial confirms that this system not only performs safely and effectively, but also supports meaningful improvements in clinical efficiency and outcomes, marking an important advancement in PE care.”

The AVENTUS Trial is a prospective, single-arm, multicenter IDE study that enrolled 130 patients with acute intermediate PE risk across 22 U.S. sites with 49 unique investigators. Patients aged 18 to 80 years old with symptomatic computed tomography angiography (CTA)-documented acute intermediate-risk PE of ≤14 days duration were eligible for enrollment. Intermediate-risk PE was defined as RV/LV ratio ≥0.9 per international guidelines.

“The AVENTUS System appears to offer a new option in the treatment of PE based on the trial’s safety and efficacy data,” said Dr. Saher Sabri, AVENTUS Trial national co-principal investigator, lead author on the JSCAI publication, and professor and chief of Interventional Radiology at Georgetown University School of Medicine. “The trial looks to deliver consistent outcomes including minimal blood loss and no device-related major adverse events. Improvement in functional outcomes at 30 days was also demonstrated across the study cohort.”

The AVENTUS Trial met its primary safety endpoint, reporting zero device-related major adverse events (MAEs) within 48 hours compared to the performance goal of 25% (p<0.0001). The primary safety endpoint was defined as the rate of device-related MAEs, a composite of death, major bleeding, clinical deterioration, pulmonary vascular injury, or cardiac injury.

Patients demonstrated a mean 0.47 reduction in core-lab-assessed right ventricle to left ventricle (RV/LV) ratio from baseline to 48 hours post-procedure, meeting the study primary endpoint (p<0.0001). Additional efficacy measures included a 35.9% improvement in refined Modified Miller Index, adjudicated by the core laboratory at 48 hours post-procedure. The trial also reported a mean ICU stay of 0.8 days, with 68.9% of patients discharged from the ICU in less than 24 hours.

“We’re proud to share this best-in-class clinical data, generated in collaboration with our leading investigators, with the broader clinical community,” Inquis Medical Co-CEO Mojgan Saadat stated. “We believe the results of the AVENTUS Trial not only demonstrate impressive safety and efficacy, but also highlight the real-world advantages of our platform technology. This represents a foundational step as we prepare to make AVENTUS widely available to physicians dedicated to saving lives with the most advanced treatment options available. We’re grateful to our investigators and their clinical teams for their partnership and dedication in achieving this important milestone.”

Inquis Medical is a clinical -stage 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 novel medical devices that address unmet clinical needs and deliver lasting impact.

The AVENTUS System is an investigational device, limited by U.S. law to investigational use.