ActiGait®: A Partly Implantable Drop-Foot Stimulator System

ActiGait is a four-channel partly implantable neuroprosthesis to control ankle dorsiflexion during the swing phase of gait. It was the goal of the developers to make a device that was easily handled by users with various levels of disabilities. To ensure optimal application of the ActiGait during market introduction, additional monitoring tools were applied and developed such as preoperative and postoperative magnetic resonance imaging (MRI), intraoperative fluoroscopy, and surface recordings of artifacts generated by the electrical stimulation of the nerve. By employing close monitoring during the establishment of new ActiGait clinical centers, ActiGait has been shown to be well accepted by users in several European countries. Experiences with the ActiGait have shown that thorough and targeted knowledge transfer to new clinical ActiGait centers, application of suitable monitoring tools, and close monitoring are all decisive in bringing a medical device such as an implantable drop-foot stimulator system successfully on the market.