American Medical Systems (Minneapolis, MN) has received FDA 510(k) clearance for the RetroArc Retropubic Sling System for treatment of female stress urinary incontinence (SUI). SUI, which affects about 13 million women in the US, causes involuntary loss of urine during coughing, laughing, or sneezing. This is certainly embarrassing and unpleasant for patients.
The RetroArc is a minimally invasive transvaginal retropubic sling system that can be used to treat SUI through an outpatient procedure. It consists of two 4mm diameter needles that provide flexural rigidity as they’re advances through the vaginal cavity. The delivery needles have a 110 degree curvature to provide an optimal trajectory to follow the back of the pubic bone and feature an atraumatic tip to allow for easier needle passage and separation from tissue with minimal damage. The system uses a polypropylene monofilament mesh sling that promotes fibrous tissue integration and improved healing, and has an adjustment suture to allow for mid-procedure changes to the sling. The handle for the RetroArc allows for one step disengagement from the needles with both visual as well as tactile cues.
The RetroArc procedure is performed by first inserting the two curved needles into the peri-urethral tunnel, such that they make contact with the posterior surface of the pubic bone, and then having them exit through a suprapubic incision. The polypropylene sling ends are then attached to the two ends of the needles protruding from the vagina, and the needles are pulled up on the side of the suprapubic incisions. The sling is positioned in the mid urethra region in a tension free manner without actually making contact with the urethra. Once optimal placement is achieved, the sling is cut at the skin level and both the vaginal and suprapubic incisions are closed.
Here’s an animation showing the implantation of the RetroArc:
Product page: The RetroArc Retropubic Sling System…