Vascular Access With Merit’s Wrapsody CIE Studied in WRAP North America Registry

August 18, 2025—Merit Medical Systems, Inc. announced that the first patient was enrolled in the company’s WRAP North America registry, which is evaluating the company’s Wrapsody cell-impermeable endoprosthesis (CIE). The company noted that the Wrapsody CIE is designed to help restore vascular access in patients on hemodialysis who experience obstructions such as stenosis or occlusion in the veins required for vascular access.

According to Merit, the WRAP North America registry will be conducted in the United States and Canada and will enroll up to 250 patients on hemodialysis who experience obstructions. The study protocol provides for the evaluation of clinical outcomes in patients treated with the Wrapsody CIE through 3 years of follow-up.

The first patient in the registry was enrolled by investigator Omar Davis, MD, who is President and Medical Director at Bluff City Vascular in Memphis, Tennessee.

“We appreciate the ingenuity and novelty of the Wrapsody CIE,” commented Dr. Davis in Merit’s press release. “Participation in this registry is an important opportunity for us to assess the ability of this device to optimize hemodialysis care for our patients.”

David J. Dexter II, MD, who is National Principal Investigator of the WRAP North America registry, added, “The Wrapsody CIE’s ability to restore vascular access for patients on hemodialysis who experience obstructions is promising. The opportunity to evaluate the Wrapsody CIE’s real-world effectiveness will help address critical questions regarding the broader impact of its use in clinical practice.” Dr. Dexter is a vascular surgeon at Sentara Health Research Center in Norfolk, Virginia.

Merit announced FDA premarket approval of the Wrapsody CIE in December 2024 and Health Canada approval in April 2025. The device received European CE Mark approval in May 2020. It is also available in Brazil, noted the company.