Safety and Performance Evaluation of Su2ura Approximation, a New Suturing Device, in Pigs

Abstract

One of the challenging aspects of minimal invasive surgery (MIS) is intracorporal suturing, which can be significantly time-consuming. Therefore, there is a rising need for devices that can facilitate the suturing procedure in MIS. Su2ura Approximation Device (Su2ura Approximation) is a novel device developed to utilize the insertion of anchors threaded with stitches to allow a single action placement of a suture. The objective of this study was to evaluate the long-term safety and tissue approximation of Su2ura Approximation in comparison to Endo Stitch + Surgidac sutures in female domestic pigs. All incision sites were successfully closed by both methods. Firm consolidation within and around the incision site was noted in several animals in both treatment groups, which corresponded histopathologically to islands of ectopic cartilage or bone spicules within the fibrotic scar. These changes reflect heterotopic ossification that is commonly seen in the healing of abdominal operation sites in pigs. No other abnormal findings were observed throughout the study period. In conclusion, the use of Su2ura Approximation under the present experimental conditions revealed no safety concerns.