Clinical Outcomes with a Combined Aspiration and Mechanical Thrombectomy Platform in 2,400 Peripheral Arterial Cases

Existing endovascular devices for peripheral arterial thromboembolism management remain suboptimal, as their single-modality approach often leaves residual thrombus. Procedures can be associated with significant blood loss and complications such as distal embolization and vessel injury. Additionally, adjunctive thrombolytic and/or additional therapy is frequently required. Recently, a novel device has been designed to address these shortcomings. Here, we report a large clinical experience with the study device and examine its performance across a broad population of patients with peripheral arterial occlusions.

Materials and Methods:

This novel device employs a combined aspiration and mechanical thrombectomy platform comprised of an aspiration catheter and mechanical thrombectomy devices with an expandable element to effectively remove acute-to-chronic arterial thrombi and emboli without adjunctive thrombolytics. The 8-French thrombectomy system also includes a covered funnel catheter capable of proximal flow restriction and a low access profile sheath. The system also allows for blood return to minimize blood loss. This analysis evaluated baseline and procedural characteristics, including thrombus etiology, estimated blood loss, adjunctive thrombolytics, % thrombus removal, and flow restoration.

Results:

Since its debut in October 2024, arterial thrombectomy with the study device was performed in 2,430 diverse cases. Thrombus etiology included preexisting peripheral artery disease or thrombosis (67%), cardiogenic embolism (14%), and iatrogenic embolism (7%). Among other segments, most treated vessels extended from the common iliac artery to the tibial runoff vessels. Median % thrombus removal was 95%. Average estimated blood loss was 46mL; blood return system was used in 11% of cases to mitigate procedural blood loss. Postprocedural thrombolysis was required in 14% of cases. Flow restoration was achieved in 93% of cases. 

Conclusion:

These promising and consistent outcomes from the study device across a large dataset highlight its potential to enhance peripheral arterial thromboembolism management and fill a critical gap in the current treatment landscape.