In separate actions, the FDA allowed the marketing of a urinary prosthesis for women and approved a supplemental new drug application (sNDA) for a lymphatic mapping agent.
The FDA has allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults with impaired detrusor contractility (IDC).
‘The inFlow is intended to address catheter-related problems and, as a prosthetic device, to compensate for a specific anatomic deficiency,” manufacturer Vesiflo, Inc. said in a press release.
The 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. 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, device insertion and removal can be performed by the patient or a caregiver.
In a press release, the FDA said it 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 de novo request was granted based on non-clinical testing and a clinical trial that enrolled 273 women with IDC using clean intermittent catheterization (CIC). Over half of the women stopped using the device as a result of discomfort and urine leakage. The trial showed that 98% of the 115 women who continued to use the inFlow device had comparable post-void residual urine volume with those who used the CIC.
“The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag. This may allow for increased mobility and the ability to be more self-sufficient,” said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health.
In Vesiflo’s press release, CEO Kevin M. Connolly said the device “allows almost normal use of a toilet.”
“[inFlow] eliminates the need to catheterize multiple times daily, eliminates tubes and drainage bags, and restores personal dignity to a population in acute need,” Connolly said.
The FDA noted that the most significant of the adverse events associated with the inFlow—urinary tract infection—appears to occur at a lower rate with the inFlow device than with CIC. Among patients treated with the inFlow device, “UTIs were stable and easily managed with antibiotics,” the FDA release said.
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