Merit Medical Systems has announced results from the arteriovenous fistula (AVF) cohort of the WRAP Global registry. Clinical data were presented at this year’s Controversies in Dialysis Access (CiDA) conference (29–31 October, Washington DC, USA).
The Wrapsody cell-impermeable endoprosthesis (CIE) was developed to restore functionality in vascular access in patients who experience stenosis and/or occlusion. Merit notes that the device’s favourable performance has been documented in the clinical trial setting.
The WRAP Global registry is an international, multicentre, prospective study designed to evaluate the performance of the Wrapsody CIE in real-world clinical practice through 24 months following device placement. A total of 237 patients were enrolled in the AVF cohort across 31 sites in nine countries. The six-month target-lesion primary patency (TLPP) was 92.7%, and the six-month access-circuit primary patency (ACPP) was 76.7%. These findings align with the patency rates observed in the AVF cohort in the WAVE pivotal trial (six-month TLPP: 89.8%; six-month ACPP: 72.8%).
“These are the results physicians have been waiting for,” said Panagiotis Kitrou (Patras University Hospital, Patras, Greece), co-global principal investigator (PI) of the WRAP Global registry and a clinical consultant to Merit Medical. “Real-world insight regarding the patency of Wrapsody provides an important benchmark for this patient population.”
“The promising patency outcomes from the WRAP Global registry are likely to improve physician confidence in the clinical benefits associated with Wrapsody and help to further optimise patient care,” said Dheeraj Rajan (University of Toronto, Toronto, Canada), co-global PI of the WRAP Global registry and a clinical advisor to Merit Medical.
The Wrapsody CIE received premarket approval from the US Food and Drug Administration (FDA) in December 2024 and was approved by Health Canada in April 2025. In January 2025, Merit began commercialisation of the device in the USA. The device previously received CE-mark approval for commercial use in the EU and is available in Brazil.
In addition to the WRAP Global registry, real-world clinical outcomes of the Wrapsody CIE are being evaluated in the WRAP North America registry, which is designed to enrol up to 250 patients in the USA and Canada.
Merit believes that the collective data from the WAVE trial, the WRAP North America registry, and the WRAP Global registry will generate evidence on the largest cohort of patients for a single indication in dialysis access to date.
