#United States #medical technology #Redmond #Vesiflo #inFlow Voiding Prosthesis

Vesiflo's inFlow™ Voiding Prosthesis Receives National Pricing Approval

On November 19, 2025, Vesiflo, Inc. announced a pivotal development in the realm of urinary health management. The company received approval from the Centers for Medicare & Medicaid Services (CMS), establishing national pricing for its groundbreaking inFlow™ Voiding Prosthesis. This decision comes as a part of the Calendar Year 2026 Medicare Physician Fee Schedule (PFS) Final Rule and is set to take effect on January 1, 2026. This change guarantees consistent nationwide coverage for physicians treating women affected by permanent urinary retention (PUR).

The approval signifies a major reimbursement milestone, offering broader patient access to a unique technology that serves as an alternative to traditional urinary catheters. The inFlow prosthesis presents a crucial option for women suffering from neurological conditions such as multiple sclerosis, spinal cord injury, spina bifida, and multiple system atrophy, which often lead to chronic catheterization needs.

Kevin Connolly, CEO of Vesiflo, expressed appreciation for the CMS's initiative in alleviating financial barriers associated with the inFlow technology. He emphasized the importance of this decision in enabling the company to expand its operations and better serve a population that significantly benefits from enhanced urinary management options.

Previously, in the 2025 Physician Fee Schedule, CMS had already issued nationally priced inFlow supply codes. They recognized the technology's potential through the strong support it received from physicians. Connolly's commitment to improving patient quality of life is echoed by Dr. Richard Schmidt, a co-inventor of Medtronic's InterStim device. Dr. Schmidt hailed the inFlow as a clinical breakthrough, emphasizing that alternatives for women requiring chronic catheterization have been exceedingly limited.

Unlike conventional catheters that merely drain urine, the inFlow Voiding Prosthesis operates via innovative technology that mimics the body's natural urination process. This advancement allows for active bladder emptying using non-contact energy transfer, thus enabling women to use a standard toilet effectively. By reinstating this vital aspect of daily living, inFlow not only enhances health outcomes but also restores dignity and independence for its users.

Research indicates that patients using the inFlow experience a reduction in urinary tract infections and significant improvements in their overall quality of life compared to standard clean intermittent catheterization (CIC). This groundbreaking technology stands at the forefront of a series of solutions aimed at redefining bladder management for individuals with chronic urological conditions.

Vesiflo, based in Redmond, Washington, continues to lead in developing innovative alternatives to urinary catheters. The inFlow Voiding Prosthesis is just the beginning of their vision to improve life quality for patients struggling with urinary retention. For further information, one can visit the official Vesiflo website at www.vesiflo.com.

This advancement marks a significant leap towards enhancing healthcare accessibility for affected individuals, transitioning them towards a more dignified life experience. As the system rolls out, the company aims to refine operational capacities to cater to this urgent need effectively.