Vesiflo, Inc., has seen its inFlow™ Urinary Prosthesis granted the U.S. FDA approval under Direct De Novo Petitioning rules.
Atonic bladder is believed to affect approximately 400,000 U.S. women with life-altering neurologic disease or injury such as stroke, multiple sclerosis, spinal cord injury, Parkinson’s, spina bifida, diabetic neuropathies, among others. Atonic bladder is generally incurable and there are few clinical options. The vast majority of women with atonic bladder use urinary catheters for bladder drainage, despite the fact that with chronic use they cause serious problems, notably urinary tract infections (UTIs), encrustation and low quality of life.
The inFlow is a non-surgical device that provides a convenient and dignified alternative to urinary catheters. It is intended to address catheter-related problems and, as a prosthetic device, to compensate for a specific anatomic deficiency. Since women with atonic bladder cannot generate bladder pressure, the inFlow pumps the urine out. It is an active device that replaces passive urinary catheters. Vesiflo says the technology involved is considerable and is the result of extensive development over a 10-plus year period.
The inFlow is an intraurethral valve-pump in a silicone housing that comes in a variety of sizes. Device sizing and initial insertion is performed by a physician. Thereafter, a new device is inserted every 29 days, typically by a caregiver or spouse. Insertion is similar to that for a urinary catheter. Since the inserted device resides almost entirely in the urethra, only the user knows it’s there. To void, the user sits on a toilet, holds a remote control over the lower pelvic area and presses a button. This magnetically activates the miniature internal pump, which drains the bladder at a normal flow rate. When the button is released, the valve is engaged, blocking further urine flow.
In its pivotal trial, the inFlow was as effective as the current standard of care, clean intermittent catheterization, in draining the bladder and improved quality of life by 54%, a difference that is statistically and clinically significant. In addition, the inFlow was shown to have the same or lower rate of urinary tract infection (UTI) as intermittent catheters, an unprecedented finding for an indwelling bladder drainage device.
Vesiflo’s CEO, Kevin M. Connolly, stated: “We are excited to offer a product that can improve the lives of so many women with serious medical conditions. The inFlow allows almost normal use of a toilet. It eliminates the need to catheterize multiple times daily, eliminates tubes and drainage bags and restores personal dignity to a population in acute need.”
Source: Vesiflo, Inc., Business Wire