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FDA Allows Marketing of Urinary Prosthesis Device for Women

Replaceable device allows urination without catheterization

The FDA has permitted marketing of the inFlow Intraurethral Valve-Pump (Vesiflo, Inc.), a replaceable urinary prosthesis for use in female adults with impaired detrusor contractility (IDC).

IDC is a condition in which patients are unable to spontaneously urinate because of 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, MD, MPH, 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.”

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, insertion and removal of the device can be performed by the patient or a caregiver. Each inserted component must be replaced at least once every 29 days.

The FDA reviewed data for inFlow through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to a legally marketed device.

The FDA granted the de novo request based on nonclinical testing and on a clinical trial that enrolled 273 women with IDC using CIC. More than half of the women stopped using the device as a result of discomfort and the leakage of urine. The study showed that 98% of the 115 women that continued to use the inFlow device had post-void residual urine volume (measurement of the amount of urine left in the bladder after urination is complete) that was comparable with that of patients who used the CIC.

Adverse events associated with the device included asymptomatic bacteriuria; urinary tract infection (UTI); bladder inflammation; genitourinary pain; hematuria; urinary leakage around the device; urinary frequency/urgency; bladder spasms; and vulvar, vaginal, and urethral disorders. The most significant of these adverse events — UTI — appeared to occur at a lower rate with the inFlow device compared with CIC. Among patients using the inFlow device, UTIs were stable and easily managed with antibiotics.

Source: FDA

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