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The eCoin Peripheral Neurostimulator System is intended for use in patients who have urgency urinary incontinence and who have not had success at treating their condition through behavior changes such as pelvic exercises, limiting fluid intake, scheduling times to urinate or through medications. What will it accomplish?
The eCoin is a coin-sized leadless battery-powered implant that stimulates the tibial nerve for the treatment of urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation.
The Post-Approval Study of eCoin® for treatment of urgency urinary incontinence (UUI) is designed to collect effectiveness and safety data in a post-approval setting.
All biocompatibility studies were conducted in compliance with Good Laboratory Practices (GLP), 21 CFR Part 58. The eCoin device is considered a permanent (> 30 days) implant in contact with tissue/bone. The following biocompatibility endpoints were assessed for this device component:
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