The US
Food and Drug Administration (FDA) has cleared for marketing a replaceable
urinary prosthesis for use in women with impaired detrusor contractility (IDC).
Called
the inFlow Intraurethral
Valve-Pump, it is manufactured by Vesiflo, Inc, of Redmond, Washington.
Women
with IDC 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," William Maisel, MD, MPH,
deputy director for science and chief scientist in the FDA's Center for Devices
and Radiological Health, said in a statement. "This may allow for
increased mobility and the ability to be more self-sufficient."
The
device has four parts: 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, the FDA says.
Initial
insertion of the device is performed by a physician. After training, it can be
inserted and removed 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 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 leakage of urine. However, 98%
of the 115 women who continued to use the inFlow device had postvoid residual
urine volume comparable with the volume of those who used the CIC, the FDA
says.
Adverse
events associated with the inFlow 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 FDA
says it's "noteworthy that 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."
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