The U.S. FDA Panel permits marketing of the inflow Intraurethral Valve-Pump, a urinary prosthesis device for women.
In a latest announcement, the U.S. Food and Drug Administration stated that it had given a nod to inflow Intraurethral Valve-Pump, a replaceable urinary prosthesis o be used by female adults who fail to contract muscle that is necessary to push urine out of their bladder (impaired detrusor contractility or IDC). The panel has reviewed the data for inflow through the de novo classification process - a regulatory pathway for low-moderate risk medical devices that are not equivalent to a legally-marketed device.
IDC is a condition in which the patients fail to spontaneously urinate due to insufficient bladder muscle contraction that results from significant neurologic disease or injury like stroke, multiple sclerosis, spinal cord injury, spina bifida or diabetic neuropathy. IDC is managed with different types of catheters including clean intermittent catheterization.
"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."
The newly approved device consists of four components: a sterilized, single-use urethral insert component with silicone shaft, fins and flange; an introducer, an activator; and a sizing component.
This device draws urine out to empty the bladder and blocks the flow of urine when continence is desired. The physicians size the patients for an inflow device and conduct the initial insertion. After training, the insertion and removal of the device can be done by the patient or a caregiver. The inserted component needs to be replaced once in every 29 days.
FDA granted the de novo request based on the clinical trial and non-clinical testing that included 273 women with IDC using CIC. Half of them stopped using the device due to discomfort and urine leakage. The trial revealed that 98 percent of 115 women that continued the use of inflow had comparable post-void residual urine volume with those who used CIC.
The side effects reported included urinary tract infection, bladder inflammation, genital and urinary pain, blood in urine, urinary leakage, urinary frequency/urgency, bladder spasms, vaginal and urethral disorders.
"The most significant of these adverse events - UTI - appears to occur at a lower rate with the inFlow device as compared to CIC. Among patients treated with the inFlow device, UTIs were stable and easily managed with antibiotics," according to press release.
The inFlow Intraurethral Valve-Pump is manufactured by Vesiflo.