CMS Establishes National Pricing for Vesiflo’s inFlow Voiding Prosthesis, Opening the Door to Broader Access and a Shift in PUR Management
The Centers for Medicare & Medicaid Services (CMS) has established national pricing for the physician procedure codes associated with Vesiflo’s inFlow™ Voiding Prosthesis, marking a major reimbursement milestone that could significantly expand patient access to a technology positioned as the first real alternative to chronic catheter use for women living with permanent urinary retention (PUR). The decision is included in the 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) and becomes effective January 1, 2026.
The ruling ensures consistent, nationwide coverage for clinicians treating PUR, an underserved patient population that has historically faced limited options, high infection risks, and profound quality-of-life burdens associated with long-term catheterization. CMS had already established national pricing for inFlow supply codes in the 2025 fee schedule, citing strong physician demand and medical-necessity rationale. The new decision completes the reimbursement pathway by aligning both device and physician procedure codes with standardized payment.
Vesiflo CEO Kevin Connolly called the milestone a turning point. “We deeply appreciate CMS’ leadership in removing payment barriers that have limited access to this transformative technology,” he said. With national pricing now in place, the company plans to expand operations to reach more patients who, in many cases, have spent years managing their condition through invasive, infection-prone methods.
A Clinically Distinct Alternative to Lifelong Catheters
PUR affects women with neurological conditions such as multiple sclerosis, spinal cord injury, spina bifida, and multiple system atrophy, who permanently lose the ability to void naturally. With no meaningful pharmacologic solutions available, clean intermittent catheterization (CIC) has long been the default standard of care, one that introduces substantial risks of recurrent infections, urethral trauma, discomfort, and daily functional burden.
The inFlow prosthesis represents a fundamentally different approach. Rather than passively draining the bladder like a catheter, the device actively empties it using non-contact energy transfer technology that simulates the natural mechanics of urination. Patients can use the toilet normally, preserving a critical activity of daily living often taken for granted.
Clinical studies cited in CMS’ earlier evaluations show that inFlow users experience:
• Fewer urinary tract infections,
• Improved bladder health, and
• Significant improvements in quality of life compared to CIC.
Women who have relied on catheterization for years often describe the treatment as exhausting, isolating, and physically intrusive. By restoring the ability to void autonomously, the inFlow aims not only to improve medical outcomes but also to return a substantial degree of independence and dignity.
Dr. Richard Schmidt, co-inventor of Medtronic’s InterStim neuromodulation platform, endorsed the technology, calling it a clinical breakthrough. “There are no good alternatives for women who require chronic catheterization,” he said. “The inFlow device is truly remarkable in its ability to virtually restore the functional behavior of the bladder. No other product, drug, can accomplish this to the same degree.”