FDA Approves Urinary Prosthesis Device for Women

Oct 15, 2014

The U.S. Food and Drug Administration approved marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder.

“The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “This may allow for increased mobility and the ability to be more self-sufficient.”

An FDA press release explains that the device has four components: 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. After 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.

The inFlow Intraurethral Valve-Pump is manufactured by Vesiflo, Inc., based in Redmond, Washington.

Read the full release

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