Mp27-12 First-in-Man Use of Rivermark Flostent™: 12-Month Report

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (MP27)1 May 2024MP27-12 FIRST-IN-MAN USE OF RIVERMARK FLOSTENT™: 12-MONTH REPORT Ingrid Perscky, Ruben Urena, and Dean Elterman Ingrid PersckyIngrid Perscky , Ruben UrenaRuben Urena , and Dean EltermanDean Elterman View All Author Informationhttps://doi.org/10.1097/01.JU.0001009400.86696.a2.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Rivermark FloStent™ is a catheter-free BPH device therapy, deliverable via working channel of a standard flexible cystoscope. METHODS: Ethics committee and health ministry approval was obtained for a first-in-human clinical trial testing primary endpoints of device deployment, tolerability, and retrievability. Secondary endpoints included safety reporting, IPSS assessment, and uroflowmetry. Due to the early stage of device development, the original study protocol specified planned cystoscopy and device retrieval at 3 months, followed by standard-of-care surgical treatment (TURP). However, based on favorable acute clinical outcomes, the study protocol was amended to allow the subjects to retain the stent up to 12 months if desired. RESULTS: 15 subjects (age 58.1±9.6 yr) with a mean prostate volume of 44.8±14.4 mL (range 20-75) and IPSS 25.2±1.4 (range 19-33) were enrolled. All attempts at implantation were successful. Devices were implanted using either standard graspers (n=4) or proprietary delivery tool (n=11). 2 subjects were explanted during the planned 3-month cystoscopy, while 13/15 subjects opted for extended follow-up and were uneventfully explanted after the 12-month visit, per amended protocol. All devices were retrieved with standard graspers, with no need for laser or thermal energy. Retrieved stents showed no signs of fracture. No gross encrustation was seen. A thin layer of epithelialization was seen in some areas. No device-related SAEs or UAEs were reported; the most common AE was urinary urgency. One subject with urinary urgency required device exchange (downsizing) 3 weeks after initial implant, with subsequent improvement in symptoms. At 3 months, 14/15 subjects had IPSS<10. At 12 months, 13/13 subjects had IPSS<10. Figure 1. FloStent™ retrieval at 12 months using standard graspers. CONCLUSIONS: First-in-human study of the Rivermark FloStent™ suggests a favorable safety profile and a high likelihood of clinical benefit up to 12 months post-implantation. While the device is intended for long-term use, standard equipment can be used to safely retrieve it, at various timepoints. A multi-center trial assessing long-term safety and efficacy is currently underway. Download PPT Source of Funding: Rivermark Medical, Inc © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e428 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Ingrid Perscky More articles by this author Ruben Urena More articles by this author Dean Elterman More articles by this author Expand All Advertisement PDF downloadLoading ...