Merit Medical Systems has achieved a significant milestone in advancing hemodialysis care with the enrollment of the first patient in its WRAP North America registry, a comprehensive real-world study of the WRAPSODY Cell-Impermeable Endoprosthesis (CIE). The enrollment took place at Bluff City Vascular, an interventional nephrology and vascular access center in Memphis, Tennessee, marking the beginning of what could become the largest registry of its kind.
Registry Design and Objectives
The WRAP North America registry represents a prospective, multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY CIE. The registry is designed to enroll up to 250 US and Canadian patients on hemodialysis who experience obstructions, such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis vascular access.
The study protocol provides for evaluation of clinical outcomes in patients treated with the WRAPSODY CIE over three years. Omar Davis, MD, President and Medical Director at Bluff City Vascular and Investigator in the WRAP North America registry, enrolled the first patient in the registry.
"We appreciate the ingenuity and novelty of the WRAPSODY CIE," said Dr. Davis. "Participation in this registry is an important opportunity for us to assess the ability of this device to optimize hemodialysis care for our patients."
Clinical Evidence Foundation
The superior performance of the WRAPSODY CIE in the clinical trial setting was previously demonstrated in the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The WAVE trial included two arms: in the randomized arm, patients with an arteriovenous fistula (AVF) were treated with the WRAPSODY CIE or percutaneous transluminal angioplasty (PTA). In the non-randomized arm, clinical outcomes of patients with an arteriovenous graft (AVG) were compared to historical outcomes of AVG patients treated with previous-generation covered stents.
David J. Dexter II, MD, FACS, National Principal Investigator of the WRAP North America registry and Vascular Surgeon at Sentara Health Research Center in Norfolk, Virginia, emphasized the clinical significance of the registry. "The WRAPSODY CIE's ability to restore vascular access for patients on hemodialysis who experience obstructions is promising," said Dr. Dexter. "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."
Regulatory Approvals and Global Expansion
The WRAPSODY CIE has achieved significant regulatory milestones across multiple jurisdictions. On December 19, 2024, the device received premarket approval from the US Food and Drug Administration (FDA). On April 30, 2025, the device was approved by Health Canada. The WRAPSODY CIE previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.
Comprehensive Clinical Evidence Strategy
The WRAP North America registry is intended to add to Merit's growing portfolio of clinical evidence supporting the WRAPSODY CIE. If completed as designed, it would represent the largest cohort of patients treated with an implantable device to restore vascular access for hemodialysis.
Real-world outcomes associated with the use of the WRAPSODY CIE are also being evaluated in the WRAP Global registry, also being conducted by Merit, which was designed to enroll up to 500 patients outside of North America. Final enrollment in the WRAP Global registry is expected by the end of 2025.
Company Leadership Perspective
Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer, highlighted the significance of this milestone. "The first patient enrolled in the WRAP North America registry is an important milestone in our ongoing efforts to collect the highest quality of evidence regarding the WRAPSODY CIE's performance," said Lampropoulos. "Advancing technology that transforms lives through improved patient care is at the heart of what we do. Helping our physician partners shape the future of dialysis is both exciting and rewarding, and we look forward to seeing the difference that the WRAPSODY CIE makes in the lives of many patients."
Merit Medical Systems, founded in 1987, is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. The company serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals and employs approximately 7,300 people worldwide.
