FDA approves urinary prosthesis for women

Redmond, Wash.-based Vesiflo has received permission from the U.S. Food and Drug Administration (FDA) to market its inFlow Intraurethral Valve Pump in the United States.

The replaceable device can take the place of a catheter in women with impaired detrusor contractility (IDC) that prevents women from contracting the muscles necessary to push urine out of the bladder, according to an FDA press release. Because this device is a pump, it draws urine out to empty the bladder but also blocks urine flow during periods of continence.

The device consists of a sterilized urethral insert component, an introducer, an activator and a sizing component. Once the individual is sized for the device and has it initially inserted by a physician, subsequent removals and insertions can be done by the individual herself or a caregiver.

In a study comparing the use of the InFlow device with clean intermittent catherization (CIC), the amount of urine left in the bladder after voiding was about the same. But rates of urinary tract infections were lower in those using the InFlow device.

“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, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health in the release. “This may allow for increased mobility and the ability to be more self-sufficient."

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