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Registry Reports Patency Data for WRAPSODY Device

Real-world results from the AVF cohort of the WRAP Global Registry were announced alongside presentation at the CiDA conference.

Updated on Nov. 5, 2026 in Heart Disease

Photograph of a coiled tubular medical endoprosthesis resting on a sterile stainless-steel tray against soft white drapes in clinical light.
The WRAP Global Registry's real-world patency data for the WRAPSODY device in dialysis access was announced by Merit Medical Systems and presented at the CiDA conference in Washington, DC. AI Illustration. Upload story photo >

Merit Medical Systems announced real-world patency results from the AVF cohort of the WRAP Global Registry, which evaluates the WRAPSODY Cell-Impermeable Endoprosthesis. The clinical data were presented at the CiDA conference in Washington, DC.

Why it matters

Real-world data show how a medical device performs in routine clinical practice rather than only in a controlled trial. The results may bear on physician confidence in the clinical benefits associated with WRAPSODY for dialysis access.

The registry reports 6-month target lesion primary patency of 92.7% and access circuit primary patency of 76.7% in 237 AVF patients across 31 sites in nine countries, versus 89.8% and 72.8% in the WAVE pivotal trial. Longer-term outcomes through the registry's 24-month follow-up period have not been reported.

The players

Merit Medical Systems

Merit Medical Systems is a medical device company headquartered in South Jordan, Utah, with approximately 7,500 employees worldwide, that develops and commercializes the WRAPSODY Cell-Impermeable Endoprosthesis.

The details

The WRAP Global Registry is an international, multicenter, prospective study that evaluates the WRAPSODY Cell-Impermeable Endoprosthesis through 24 months after placement. Merit Medical says the collective data from the WAVE trial, WRAP North America registry and WRAP Global registry will form evidence on the largest cohort for a single dialysis access indication to date.

Timeline

  1. December 2024: FDA granted premarket approval for WRAPSODY CIE.

  2. January 2025: Merit began commercializing the device in the United States.

  3. April 2025: Health Canada approved the WRAPSODY CIE.

  4. October 31, 2026: Clinical data were presented at the CiDA conference in Washington, DC.

  5. November 5, 2026: Merit announced the registry results.

Health Landscape

WRAPSODY received FDA premarket approval in December 2024, the regulatory pathway that requires clinical evidence before a device is marketed in the United States. The registry data add post-market evidence on how the device performs in routine dialysis access care rather than only in controlled pivotal trials.

For patients on dialysis who depend on vascular access, device performance over time affects how often procedures to keep an access circuit open may be needed. The registry data offer patients and clinicians a view of patency outcomes in routine practice, which may inform discussions with their care teams.

The takeaway

Real-world registry data can reveal how a device performs across many patients and sites over time. Readers tracking dialysis access options may find longer-term follow-up data useful as the registry continues.

Further reading

For broader context on cardiovascular and vascular treatment, explore our Heart Disease coverage.

More information

Review product information for the device on the WRAPSODY CIE product page from Merit Medical.

Source note: This article includes information reported by The Manila times.