AVENTUS Thrombectomy System Shows Promise for Pulmonary Embolism Treatment in Pivotal Trial
核心洞察
The AVENTUS Trial successfully met its primary safety and efficacy endpoints for treating acute intermediate-risk pulmonary embolism (搜索), with zero device-related major adverse events reported.
Patients showed significant improvement in right ventricular function with a mean 0.47 reduction in RV/LV ratio and 35.9% improvement in clot burden as measured by the Modified Miller Index.
The system demonstrated clinical efficiency with minimal blood loss, a mean ICU stay of just 0.8 days, and meaningful improvements in patient quality of life and functional capacity through 30 days.
Inquis Medical (搜索) announced promising results from its AVENTUS Trial evaluating the company's novel thrombectomy system for pulmonary embolism (搜索) (PE) treatment. The findings, presented at the 2025 Society of Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions in Washington, D.C., demonstrated both safety and efficacy in treating acute intermediate-risk PE patients.
Dr. Jun Li, Co-Director of the Vascular Center and Pulmonary Embolism (搜索) Response Team at University Hospitals Harrington Heart & Vascular Institute and the trial's National Co-Principal Investigator, presented the results during a Late-Breaking Clinical Trial Session. The study was simultaneously published in JSCAI, the society's peer-reviewed journal.
"There remains a clear need for next-generation technologies that can address some of the limitations of current PE devices," said Dr. Li. "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."
Trial Design and Patient Population
The AVENTUS Trial was a prospective, single-arm, multicenter IDE study that enrolled 130 patients with acute intermediate-risk PE across 22 U.S. sites, involving 49 unique investigators. Eligible patients were between 18 and 80 years of age with symptomatic computed tomography angiography (CTA)-documented acute intermediate-risk PE of ≤14 days duration. Intermediate-risk PE was defined as a right ventricle to left ventricle (RV/LV) ratio ≥0.9, in accordance with international guidelines.
Safety Outcomes
The trial met its primary safety endpoint with zero device-related major adverse events (MAEs) within 48 hours, significantly outperforming the predetermined performance goal of 25% (p<0.0001). The primary safety endpoint was a composite of death, major bleeding, clinical deterioration, pulmonary vascular injury, or cardiac injury.
Efficacy Results
Patients demonstrated a mean 0.47 reduction in core-lab-assessed RV/LV ratio from baseline to 48 hours post-procedure, meeting the study's primary efficacy endpoint (p<0.0001). Additional efficacy measures included a 35.9% improvement in the refined Modified Miller Index, which measures clot burden, as adjudicated by the core laboratory at 48 hours post-procedure.
The trial also reported impressive clinical efficiency metrics, including a mean ICU stay of just 0.8 days, with 68.9% of patients discharged from the ICU in less than 24 hours. Patients also experienced meaningful improvements in quality of life and showed a significant increase in six-minute walk test (6MWT) distance through the 30-day follow-up period.
Expert Perspectives
Dr. Saher Sabri, National Co-Principal Investigator of the AVENTUS Trial, lead author on the JSCAI publication, and Professor and Chief of Interventional Radiology at Georgetown University School of Medicine, commented on the findings: "The AVENTUS System appears to offer a new option in the treatment of PE based on the trial's safety and efficacy data. The trial included 49 unique users across 22 sites, and 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."
Clinical Significance
Pulmonary embolism (搜索) remains a significant health concern with substantial morbidity and mortality. Intermediate-risk PE patients represent a challenging population that may benefit from interventional approaches that can rapidly reduce clot burden and improve right ventricular function without increasing bleeding risk.
The AVENTUS System appears to address several limitations of current thrombectomy devices, potentially offering a safer and more efficient option for PE treatment. The system's ability to minimize blood loss while effectively removing clots represents a meaningful advancement in interventional PE management.
Company Perspective
"We're proud to share this best-in-class clinical data, generated in collaboration with our leading investigators, with the broader clinical community," said Mojgan Saadat, Co-CEO of Inquis Medical (搜索). "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."
Future Implications
While the AVENTUS System remains an investigational device limited by federal law to investigational use, the positive trial results suggest it may soon provide clinicians with an important new tool for PE management. The system's demonstrated safety profile, efficacy in reducing clot burden, and efficiency benefits could potentially improve outcomes for patients with intermediate-risk PE.
The company has not yet announced specific plans for regulatory submission, but the successful completion of this pivotal trial represents a significant milestone toward potential market approval.
Inquis Medical (搜索), founded in 2020, focuses on developing next-generation thrombectomy technology designed to provide physicians with improved control and precision, enhance procedural efficiency, and minimize blood loss in the treatment of venous thromboembolic disease (搜索).