MP09-03 EVOLUTION OF THE ZENFLOW SPRING SYSTEM: A NOVEL NITINOL IMPLANT FOR BENIGN PROSTATIC HYPERPLASIA (BPH)

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II (MP09)1 Sep 2021MP09-03 EVOLUTION OF THE ZENFLOW SPRING SYSTEM: A NOVEL NITINOL IMPLANT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) Peter Chin, Lauro Salvador Gomez Guerra, Peter Gilling, Juan José Galán Maraboto, Rodrigo Perez Becerra, and Janelle Brennan Peter ChinPeter Chin More articles by this author , Lauro Salvador Gomez GuerraLauro Salvador Gomez Guerra More articles by this author , Peter GillingPeter Gilling More articles by this author , Juan José Galán MarabotoJuan José Galán Maraboto More articles by this author , Rodrigo Perez BecerraRodrigo Perez Becerra More articles by this author , and Janelle BrennanJanelle Brennan More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001982.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Zenflow Spring® System (Zenflow, South San Francisco, CA, USA) is a novel, minimally-invasive device designed to relieve LUTS associated with BPH. The permanent Spring Implant is delivered transurethrally to the prostatic urethra using a flexible cystoscope. If needed, the implant is uniquely designed for complete transurethral removability using standard urological instruments. We present the technology and evolution of the Zenflow Spring System. METHODS: The first-generation Spring Implant consisted of a single 3-ring nitinol coil. Under flexible cystoscopic guidance, the device was deployed in the prostatic urethra to produce an outward force and increase the patency of the prostatic urethral lumen. Experience from the first-in-human study led to a new Spring System design including a custom delivery system, an integrated and proprietary single-use flexible cystoscope, and additional implant sizes. RESULTS: The initial feasibility study confirmed both acute and long-term potential benefit of the Spring Implant as viable treatment option for BPH. Eleven subjects were successfully implanted with no unanticipated serious adverse events. Symptom improvement was observed and shown to be durable up to 3 years in most of the subjects treated. Mean IPSS change was -10.8 (-43%) at 3 months (p <0.001) and -10.6 (-42%) at 36 months, (p <0.001). Explant procedures were successfully performed when needed, transurethrally, up to 32 months post-procedure. The Zenflow Spring System, currently under clinical investigation in Mexico, New Zealand, and Australia, has enhanced visualization, placement accuracy, and urethral fit, demonstrating preliminary safety and effectiveness results. CONCLUSIONS: Preliminary safety and effectiveness results from the first-generation Spring System support the long-term durability of the Spring Implant. Design changes made as a result of the first-in-human study have significantly improved the procedural experience while continuing to demonstrate treatment success. These initial clinical experiences support the continued evaluation of the Zenflow Spring System as a minimally-invasive treatment alternative for patients with LUTS associated with BPH. Source of Funding: Study was funded solely by the study sponsor, Zenflow, Inc © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e160-e160 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Peter Chin More articles by this author Lauro Salvador Gomez Guerra More articles by this author Peter Gilling More articles by this author Juan José Galán Maraboto More articles by this author Rodrigo Perez Becerra More articles by this author Janelle Brennan More articles by this author Expand All Advertisement Loading ...