FDA permits marketing of urinary prosthesis device for women

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Title: FDA permits marketing of urinary prosthesis device for women
Office of Women's Health, FDA

October 2014
http://www.fda.gov/womens

FDA permits marketing of urinary prosthesis device for women

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. Read more


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