UroMems Awarded FDA IDE to Use Artificial Urinary Sphincter in Pivotal Trial

UroMems awarded FDA IDE to use artificial urinary sphincter in pivotal trial

UroMems is set to enter the pivotal trial phase with its device for treating stress urinary incontinence (SUI).The post UroMems awarded FDA IDE to use artificial urinary sphincter in pivotal trial appeared first on Clinical Trials Arena.

FDA, French ANSM greenlight pivotal trial of UroActive smart implant for male SUI

The SOPHIA2 trial will assess the safety and efficacy of the UroActive implant in men with SUI.

UroMems Receives Clearance from the FDA and the French ANSM for Initiating Landmark Pivotal Clinical Study of UroActive® Smart Implant to Treat Male Stress Urinary Incontinence

IDE approval in both countries follows strong feasibility clinical results in France

UroMems Secures FDA And ANSM Clearance For Clinical Study

UroMems receives clearance to start pivotal study of UroActiveÒ implant for treating male stress urinary incontinence.