As a result, the company plans to go ahead with the U.S. rollout for the cell-impermeable endoprosthesis (CIE).
“We have elected to withdraw our application for TPT incremental payment and intend to begin our full commercialization of the Wrapsody CIE in the U.S. immediately,” said Martha G. Aronson, Merit president and CEO.
CMS notified Merit of its decision to defer its application for Transitional Pass-Through (TPT) payment for Wrapsody in outpatient and ambulatory surgery center (ASC) settings, as it needs more time to make a final decision. It deferred the application to the Calendar Year 2027 Outpatient Prospective Payment System rule. That makes Jan. 1, 2027, the earliest possible effective date.
“While we are disappointed with the deferral of our application for TPT incremental payment, we believe this presents an opportunity for an important strategic pivot,” Aronson said. “Our efforts to secure incremental payment in the outpatient and ASC settings have impacted the pace of U.S. commercialization of our innovative solution for physicians treating hemodialysis patients suffering from venous outflow obstructions.”
More about Wrapsody and the new strategy for Merit Medical following the CMS decision
South Jordan, Utah-based Merit designed Wrapsody to extend long-term vessel patency in dialysis patients. It consists of a proprietary covering that features a nitinol stent frame enveloped by an expandable polytetrafluoroethylene (PTFE) outer layer.
Merit Medical said the nitinol frame provides enhanced radial force, compression resistance and softened ends to help conform to vessels, withstand physiological compression and reduce stress on the vessel walls. The company aims to address stenosis in hemodialysis patients in ways it says covered stents may fail to.
Wrapsody received FDA approval at the end of 2024. However, it now must wait for reimbursement in certain settings until at least 2027.
Aronson said the company plans to enact a new commercial strategy to increase patient access and optimize adoption and utilization for Wrapsody. The company says it expects the move to improve patient outcomes, reduce the cost of treatment and generate revenue growth.
Merit continues to expect U.S. revenue from Wrapsody in the range of $2 million to $4 million in 2025.
“We expect this strategy to improve patient outcomes, reduce the cost of treating this large and growing patient population, and generate strong, margin-accretive revenue growth for Merit in the years to come,” said Aronson. “Armed with the best technology, the strongest clinical evidence, and a focused and engaged commercial team, we believe we are well positioned to penetrate the U.S. dialysis access maintenance market opportunity in the coming years.”
