|Vesiflo's inFlow device--Courtesy of Vesiflo|
In a regulatory win, Washington's Vesiflo got an FDA green light to market its replaceable urinary prosthesis for female adults with bladder drainage problems.
The company's inFlow Intraurethral Valve-Pump helps women suffering from impaired detrusor contractility (IDC), a condition in which patients cannot contract the muscles necessary to push urine out of the bladder. IDC is usually managed with catheters, but the inFlow device allows women with IDC to urinate without catheterization or a urine bag, allowing for increased mobility and self-sufficiency, Dr. William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in a statement.
Vesiflo received regulatory clearance for its inFlow Intraurethral Valve-Pump through the agency's de novo classification process, a pathway for low- to moderate-risk medical devices with no market equivalent. The FDA based its decision on nonclinical testing and a clinical trial of 273 women with IDC using catheterization. Over half the women in the trial stopped using the catheter device due to leakage and discomfort, and 98% of the 115 women who continued to use the inFlow device had comparable amounts of urine left in the bladder as those who used a catheter.
The inFlow pump includes a sterilized, single-use urethral component with a silicone shaft, introducer and activator that draws urine out to empty the bladder and blocks urine flow. A physician initially sizes the patient and inserts the pump, but patients and caregivers can replace or remove the device with training, according to the FDA statement.
Vesiflo is not the only company developing devices for urinary incontinence. Last year, California's NeoTract won U.S. regulatory approval for its UroLift permanent implant for older men with enlarged prostates. The device helps patients ages 50 and older who are suffering from low or blocked urine and provides an alternative to drug therapy or surgery. In May, InControl Medical snagged 510(k) clearance to market its InToneMV pelvic floor rehabilitation product for men with urine leakage. The device contains a muscle stimulation probe and remote enabling system and provides voice-guided exercises and visual biofeedback.
- read the FDA release