Replaceable Urinary Prosthesis For Women Cleared by FDA

The Food and Drug Administration (FDA) has granted marketing clearance for the inFlow Intraurethral Valve-Pump (Vesiflo, Inc.), a replaceable urinary prosthesis for use in female adults with impaired detrusor contractility (IDC).

The device contains the following: a sterilized, single-use urethral insert component with silicone shaft, fins, and flange; an introducer; an activator; and a sizing component. The device draws urine out to empty the bladder and blocks urine flow when continence is desired. A physician sizes the patient for an inFlow device and performs the initial insertion; following training, device insertion and removal can be performed by the patient or a caregiver. Each inserted component must be replaced at least once every 29 days.

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The FDA decision was based on data from non-clinical testing and a clinical trial of 273 female patients with IDC using clean intermittent catheterization (CIC). More than half the women ceased using the device due to discomfort and leakage of urine. Of the 115 women who continued to use the inflow device, 98% had comparable post-void residual urine volume with those who used the CIC. The data was reviewed through the de novo classification process.

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