Associate Professor University of Maryland, United States
Purpose: Existing endovascular therapies for peripheral arterial occlusions are limited by safety concerns, procedural inefficiencies, and inconsistent efficacy {1-4}. Because most devices rely on a single mechanism of thrombus removal, treatment often requires adjunctive thrombolytics or additional interventions, particularly in cases with large or chronic thrombus burden {1-3}. The Artix System is a dual aspiration and mechanical thrombectomy solution designed to remove acute-to-chronic arterial thrombi and emboli in a single session without the need for thrombolytics. The over-the-wire system includes an aspiration-capable 8-F sheath with a 7-F access profile, aspiration catheter, mechanical thrombectomy device containing an expandable element, and covered funnel catheter for proximal flow restriction. Herein, we report the first multicenter evaluation of the study device for the treatment of peripheral arterial occlusions.
Materials and Methods: Between November 2024 and September 2025, 22 consecutive patients with acute lower extremity arterial occlusions who underwent thrombectomy with the study device were retrospectively analyzed. Baseline and procedural characteristics were evaluated, including thrombus etiology, adjunctive thrombolytics, median estimated blood loss, % thrombus removal, and flow restoration. Safety events were collected and limb salvage rate at 30 days was analyzed.
Results: Treated vessels extended from the common iliac artery to the tibial runoff vessels. Thrombus etiology included preexisting peripheral artery disease or thrombosis (36%), cardiogenic embolism (50%), and iatrogenic embolism (5%). Average estimated blood loss was 50±34mL. Postprocedural thrombolysis was required in 5% of cases, and 95% of cases were in a single session. Average thrombus removal was 97±3%. Flow restoration was 100%. Safety profile was favorable with 0% distal embolization and 0% vessel injury. Of the available data at the 30-day follow up visit, limb salvage rate was 100%.
Conclusion: These early outcomes from the study device show its potential to enhance peripheral arterial occlusion management. Further studies are needed to validate its safety and effectiveness.
