First‐in‐human implantation of a mid‐field powered neurostimulator at the sacral nerve: Results from an acute study

Abstract

Introduction Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. Materials and Methods A first‐in‐human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. Results During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. Conclusions The results from this acute first‐in‐human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid‐field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device.

Overactive Bladder: Where We Are and Where We Are Going

“…This new device is a miniature implantable stimulator that can be placed into the S3 foramen and differs from the existing SNM technology in that in lieu of an internal IPG, the AHLeveeS System uses an external wireless generator. The use of this device in a small pilot study was seen to produce physiologic responses consistent with adequate stimulation of the S3 nerve root foramina, including bellows and great toe plantarflexion [88]. Table 1 shows the major third-line therapies and the corresponding emerging technologies for OAB.…”