Vesiflo Unveils inFlow Device and Its Companion Patient Monitoring System

Doctors recently got their first look at Vesiflo Inc.’s inFlow urinary prosthesis for women and its companion app/information system.

Unveiled publicly for the first time since its U.S. Food and Drug Administration approval in October 2014, Vesiflo demonstrated both the prosthesis and the inFlow Patient Support System (PSS). The company expects to fully launch the inFlow device and PSS in the fourth quarter of this year.

The target population for the inFlow is women with impaired detrusor contractility (IDC), a medical condition where patients are unable to spontaneously urinate because they cannot generate bladder pressure. IDC is most often the result of a life-changing neurologic disease or injury such as multiple sclerosis, stroke, spinal cord injury, Parkinson’s, spina bifida, diabetic neuropathies, and others. IDC generally is incurable and there are few clinical options. Most women with IDC now use urinary catheters on a life-long basis, despite the problems known to be associated with chronic catheterization, notably urinary tractinfections (UTIs),encrustation and low quality of life.

The inFlow is intended to address catheter-related problems and, as a prosthetic device, to compensate for a specific anatomic deficiency, company executives noted in a news release. Since women with IDC cannot generate bladder pressure, the inFlow pumps the urine out. It is an active device that replaces passive urinary catheters. A pivotal trial showed the inFlow to have a lower rate of UTIs and higher quality of life than clean intermittent catheterization, the current standard of care, bigwigs said. The technology involved is the result of extensive development over more than a decade.

“The inFlow restores personal dignity to women in acute need. It mimics normal urination and eliminates the need to catheterize multiple times daily or use tubes and drainage bags,” CEO Kevin M. Connolly said. “The PSS builds on the inFlow’s core magnetic transfer technology to monitor the safety of its users and support them in optimizing their bladder health.”

The central component in the PSS is the inFlow’s “smart” remote control, the Activator. Each time an inFlow user voids, the Activator automatically transmits their voiding volume and other clinical event data to its base station and/or an iOS app, which in turn sends these data to the cloud. Collecting key clinical data automatically, i.e., without requiring any additional effort by the patient, increases the ability of the PSS to identify unhealthy indicators early, providing the opportunity for early intervention. The PSS also can prompt users to increase hydration and other bladder-healthy behaviors and will generate reports regarding their voiding for clinicians and payers.

Based in Redmond, Wash., Vesiflo manufactures urinary bladder drainage products.