Inquis Medical has reported that the single-arm trial of its Aventus thrombectomy system in treating individuals with acute intermediate-risk pulmonary embolism (PE) met its primary endpoints.
The multicentre, investigational device exemption (IDE) ‘AVENTUS Trial’ assessed the efficacy and safety of the system in 130 subjects enrolled across 22 US sites.
The trial subjects included those aged 18 to 80 years with symptomatic computed tomography angiography (CTA)-documented acute intermediate-risk PE for of less than or equal to 14 days duration.
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According to the findings, patients reported improvement in right ventricular (RV) function, decrease in clot burden, and blood loss.
In the trial, improvements in patient-reported quality of life and a notable increase in six-minute walk test (6MWT) distance were observed through 30 days.
The trial also met primary safety endpoint with no device-related major adverse events (MAEs) observed within 48 hours post-procedure.
Subjects in the trial showed a mean 0.47 decrease in the core-lab-evaluated RV to left ventricle (LV) ratio from baseline to 48 hours after the procedure, meeting the trial’s primary efficacy endpoint.
Furthermore, a 35.9% improvement in the refined Modified Miller Index and a mean intensive care unit (ICU) stay of 0.8 days was reported in the trial with 68.9% of subjects being discharged from the ICU in less than 24 hours.
Inquis Medical co-CEO Mojgan Saadat said: “We’re proud to share this best-in-class clinical data, generated in collaboration with our leading investigators, with the broader clinical community. 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 sincerely grateful to our investigators and their clinical teams for their partnership and dedication in achieving this important milestone.”
In November 2024, Inquis Medical closed its $40m Series B oversubscribed financing round for expediting the advancement of its Aventus thrombectomy system, intended to address venous thromboembolism.
