Vesiflo announced that its Direct De Novo Petition for the inflow Urinary Prosthesis has been granted by the US Food and Drug Administration (FDA), allowing the inFlow to be freely marketed in the US.
The inFlow is a non-surgical device that provides a convenient and dignified alternative to urinary catheters. Its target population is women with atonic bladder, a medical condition where patients are unable to spontaneously urinate due to impaired detrusor contractility.
Atonic means "no tone" – they cannot generate bladder pressure. 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, etc.
Although urinary catheters may be the most commonly used medical devices, with chronic use they cause serious problems, notably urinary tract infections (UTIs), encrustation and low quality of life.
These problems are amplified for women with atonic bladder as they must now use urinary catheters on a life-long basis. The inFlow 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. The technology involved is considerable and is the result of extensive development over a 10-plus year period.
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."