Proof-of-Concept Study Evaluating the Performance and Physiologic Response of the FloStent Prostatic Stent in a Healthy Canine Model

Abstract

AbstractThe purpose of this study was to evaluate the deliverability, tolerability, and retrievability of a novel prostatic stent (the FloStent System™) in a healthy canine model. This was a non-randomized, as-treated study. Implantations were performed using a novel fluoroscopic technique. Animals were followed up to 30 days. No stent migration occurred; the stent was well tolerated; retrieval procedures were successful. Gross pathology and histopathological findings were consistent with minimal trauma caused by the implant procedures. The FloStent prostatic implant was demonstrated adequate functionality and safety in this healthy animal model, which supports plans for future use in human studies.