FDA Permits Marketing of Vesiflo’s inFlow Device for Women

The U.S. Food and Drug Administration (FDA) has permitted Vesiflo Inc. to market its inFlow Urinary Prosthesis in the United States.

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 inFlow is a non-surgical device that provides an 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 (IDC). 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. 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.

“The inFlow device allows women with IDC to urinate, without the need to catheterize daily or be attached to a urine drainage bag,” said William Maisel, M.D., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “This may allow for increased mobility and the ability to be more self-sufficient.”

Although urinary catheters may be the most commonly used medical devices, with chronic use they cause serious problems, notably urinary tract infections, 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 the result of extensive development over more than a decade, the company claims.

“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,” Vesiflo CEO Kevin M. Connolly said.

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 percent, a difference that is statistically and clinically significant, according to Vesiflo. In addition, the inFlow was shown to have the same or lower rate of urinary tract infection as intermittent catheters.

The inFlow Urinary Prosthesis also is sold in Europe, including in Germany, where it is reimbursed by that nation’s health system. Prior to broader market launch in the U.S., the inFlow will be available in certain centers of excellence.