FairEmbo Concept for Arterial Embolizations: In Vivo Feasibility and Safety Study with Suture-Based Microparticles Compared with Microspheres

Abstract

Purpose: Microspheres are effective embolic agents especially for the management of bleeding and oncologic lesions. The first FairEmbo study reported the effectiveness of embolization using suture fragments. The effectiveness and safety of arterial embolization with Suture-Based Microparticles (SBM) were assessed in a swine model. Materials and methods:In this ethical-approved animal study, a polar artery in each kidney was embolized in four swine: one side with hand-cut non-absorbable SBM (Flexocrin 2 ® ) and the contralateral side with Embozene ® 900 for comparison. Swine were followed for 3 months (M3) to evaluate the effectiveness and the safety of SBM.Follow-up protocol included clinical monitoring, computed tomography (CT) control and digital subtraction angiography (DSA), followed by histological analyses. The SBM confection parameters were evaluated by automatic microscopic sizer. RStudio software and Mann-Whitney test (significance at P<0.05) were used for statistics. Results:The average size of SBM was 1002μm (SD=258). All targets were effectively embolized by SBM, with an angiogram defect estimated at 45.6% (95% CI [35.9-55.2]), compared to 40.5% (95% CI [30.6-55.5]) for Embozene ® group, without significant difference (P=0.342). The average duration of SBM embolization procedure was significantly increased compared to Embozene ® embolization (1202s versus 222s, P=0.029). There were no statistical differences in M3 DSA and CT for SBM and Embozene ® , with persistence of partial arterial occlusion and atrophic embolized area. No postoperative complications were observed on clinical and CT controls. Conclusion:This experimental study suggests that embolization with SBM is safe and effective in short and medium-term follow-up as compared to microspheres.

FairEmbo Concept for Postpartum Hemorrhage: Evaluation of the Efficacy of Suture Fragment Compared with Gelatin Sponge Torpedo Embolization in a Post-Gravid Swine Model

“…The feasibility of using suture fragments has been demonstrated in previous preclinical studies and through a clinical case reported in 2020 [ 10 , 11 , 12 ]. This study demonstrated the feasibility and efficacy of suture embolization through a new and previously untested application: uterine artery embolization in a female porcine model in which the uterine arteries were stimulated by gonadotropin hormone administration.…”

“…The FairEmbo concept aims to make available a worldwide, effective, and safe embolization agent, either using absorbable or non-absorbable sutures. It has recently demonstrated that embolization with suture fragments is feasible and effective in short- and medium-term follow-up in porcine models [ 10 , 11 ]. Its clinical efficacy was also demonstrated by clinical case emergency embolization of a renal artery pseudoaneurysm in 2020 [ 12 ].…”

Interventional Radiology for Whom

“…One key to solve the problem may be ''technique''. The paper, ''FairEmbo concept for arterial embolizations: In vivo feasibility and safety with suture-based microparticles compared with microspheres'' introduced the technique of ''cutting the thread into small pieces'' and showed the possibility that this technique can reduce the cost of IR [3]. In the current trend where most interventional radiologists hope to use expensive and high quality imaging equipment and devices, the attitude of conducting research and publishing papers from the viewpoint of ''cheaper IR'' is commendable [4,5].…”