AVENTUS | Inquis Medical

Advancing the Treatment of Pulmonary Embolism¹

Safe, effective, and efficient, with integrated blood reinfusion

Outstanding Clinical Performance in all Key Metrics

Device-related MAEs
within 48 hours and
through 30 days

RV/LV Ratio

Clot burden reduction based on change in refined modified Miller score

Trial met both primary safety and efficacy endpoints
Demonstrated significant improvement in RV/LV ratio and large clot burden reduction
Minimal blood loss facilitated by blood reinfusion features
Brief post-procedure ICU and total hospital length of stay

Review ‘Novel Aspiration Thrombectomy and Blood Reinfusion System for Acute Intermediate-Risk Pulmonary Embolism: AVENTUS Trial Results’ in JSCAI.

About the Study

Objective

Evaluate the safety and efficacy of the AVENTUS Thrombectomy System for aspiration thrombectomy in subjects with acute intermediate-risk pulmonary embolism.

Duration of follow-up: 30 days

Study Design

Prospective, single-arm, multicenter IDE trial
Conducted at 22 U.S. sites
Enrolled 120 subjects with acute intermediate-risk PE

Primary Efficacy Endpoint

Change in RV/LV ratio from baseline (pre-procedure) to 48 hours post-procedure as measured by CTA

Key Eligibility Criteria

Subjects aged 18 to 80 years old
Symptom duration ≤ 14 days
CTA-documented emboli in pulmonary arteries
RV/LV ratio of ≥ 0.9

Primary Safety Endpoint

Rate of device-related major adverse events (MAEs) within 48 hours of the procedure:

Death
Major bleed
Clinical deterioration

Pulmonary vascular injury
Cardiac injury

Baseline Characteristics

84.3%

Concomitant deep vein thrombosis

66.1%

Pulmonary hypertension on presentation

87.5% Intermediate/High risk patients

Elevated troponins or BN

Significant Improvement in Right Ventricular (RV) Function and Reduction in Clot Burden

RV/LV ratio decrease
48-hour RV/LV diameter ratio dropped significantly, by an average of 0.47 (p<0.0001)

Clot burden reduction
The refined modified Miller score decreased by an average of 35.9%.

Clot Haul

(A) Pre-procedure CT and (B) 48 hours post-procedure CT (C) Left pre-aspiration angiogram (D) Left post-aspiration angiogram. Case images provided by Dr. Samuel Horr (TriStar Centennial Medical Center, Nashville, TN).

Exceptional Safety Results

0%

Device-related
MAEs within 48-hours

0%

30-day device-related
MAE or SAE

AVENTUS was Highly Adoptable With Reproducible Outcomes

Diverse Operators

Median Catheter Dwell Time

(Tracking, aspiration, and blood filter/reinfusion)

Minimal Blood Loss: <50mL of Mean Estimated Blood Loss per Patient

99%

received blood filtration and reinfusion

49.6mL

estimated blood loss

0%

blood transfusions within 48 hours

Improved Functional and QoL Outcomes With Short Length of Stay

PEmb-QoL
30-day score demonstrated decreased symptoms with a reduction of 25.3 points overall (p<0.0001)

6 Min Walk Distance
At 30 days, subjects exhibited a 132.9-meter increase in 6MWD (p<0.0001)

56.3%

had no ICU stay

12.6%

had < 24 hour ICU stay

0.8 day

Mean ICU stay

2.6 day

Mean hospital stay

The AVENTUS Trial met its primary endpoints, demonstrating both safety and efficacy for the treatment of patients with intermediate-risk pulmonary embolism (PE). Results showed significant improvement in right ventricular (RV) function, reduction in clot burden, minimal blood loss, and shorter ICU and hospital stays, with no device-related adverse events reported.

Caution – Investigational Device, Limited by Federal Law to Investigational Use.

¹The AVENTUS trial was conducted under clinicaltrials.gov ID NCT05907564.