The U.S. Food and Drug Administration today allowed 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 (impaired detrusor contractility or IDC).

IDC is a condition where patients are unable to spontaneously urinate due to insufficient bladder muscle contraction, which can result from significant neurologic disease or injury such as stroke, multiple sclerosis, spinal cord injury, spina bifida or diabetic neuropathy. IDC is typically managed with various types of catheters, including clean intermittent catheterization (CIC).

“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.”

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