Merit Medical Systems, Inc. has provided an update on its U.S. reimbursement and commercial strategies for the Wrapsody® Cell-Impermeable Endoprosthesis. The company announced that its application for transitional pass-through incremental payment for Wrapsody® procedures in outpatient and ambulatory surgery center settings has been deferred by the U.S. Centers for Medicare & Medicaid Services ("CMS") to the calendar year 2027.
As a result, Merit has decided to withdraw its application for transitional pass-through incremental payment and intends to begin full commercialization of the Wrapsody® Cell-Impermeable Endoprosthesis in the U.S. immediately. The company believes that this new commercial strategy will increase patient access, optimize adoption, and utilization of the technology, leading to improved patient outcomes, reduced treatment costs, and strong revenue growth.
Despite the setback, Merit remains confident in the clinical evidence supporting the Wrapsody® Cell-Impermeable Endoprosthesis. The device has shown remarkable 24-month efficacy results from both the randomized arteriovenous fistula arm and single-arm arteriovenous graft cohort of the Wrapsody Wave trial. This clinical data serves as a key differentiator against existing competitors, providing Merit with a strong position in the U.S. dialysis access maintenance market opportunity in the years to come.
For the full year 2025 period, Merit forecasts U.S. revenue from the sales of the Wrapsody® Cell-Impermeable Endoprosthesis to be in the range of $2 million to $4 million.
It's worth noting that the Wrapsody® Cell-Impermeable Endoprosthesis received premarket approval from the U.S. Food and Drug Administration on December 19, 2024, and was approved by Health Canada on April 30, 2025. The device had previously received the Conformité Européenne (CE) mark for commercial use in the European Union and is available in Brazil. As a result of these announcements, the company's shares have moved -0.78% on the market, and are now trading at a price of $87.43. For the full picture, make sure to review MERIT MEDICAL SYSTEMS INC's 8-K report.
