עדי יהודה ווינטראוב

Introduction and hypothesis: The objective was to demonstrate the biomechanical properties, feasibility, and potential advantages over conventional techniques of this new anchoring device, NeuGuide™. Methods: We evaluated the pull-out forces required to pull the NeuGuide™ anchor elements from a uniform porcine ligament and a cadaver ligament. We also evaluated the function of the NeuGuide™ and the characteristics of the device for the establishment of verification evidence ensuring the reliability and feasibility of the device. We also evaluated the safety and performance of the NeuGuide™ procedure in female cadavers by palpating the sacro-spinous ligament in real time. We assessed the ability to deploy and fixate the anchor to the sacro-spinous ligament and to stitch the sutures from both sides of the vaginal apex to the cervix, without damaging the surrounding structures. Results: All 12 anchors were inserted into the porcine ligament and the cadaver sacro-spinous ligaments successfully (mean pull-out force 34.13 ± 4.32 and 35.68 ± 9.28 respectively). None of the measured forces were below 20 N. No statistically significant difference was noted in the pull-out forces between the porcine and the cadavers (p = 0.60), between the two cadavers (p = 0.19) and between the right and left sacro-spinous ligaments. No abnormalities or malfunctions were noted in the functional performance of the device. Upon laparotomy, dissection of the cadavers revealed that the sacro-spinous ligaments were reached safely with no damage to the surrounding organs and tissues. Conclusions: This novel anchoring device (NeuGuide™) is aimed at facilitating a durable, easy, and short procedure for sacro-spinous ligament fixation with hypothetically fewer operative complications.