Introducing a true minimally invasive meshless and dissectionless anchoring system for pelvic organ prolapse repair.

Abstract

The objective was to demonstrate the biomechanical properties, feasibility, and potential advantages over conventional techniques of this new anchoring device, NeuGuide™. 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. 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. 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.