Merit Medical Begins Enrolling Patients in WRAP Study

Merit Medical Systems Inc. has enrolled the first patient in the WRAP North America registry.

The registry will enroll up to 250 U.S. and Canadian patients on hemodialysis who experience obstructions such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis (vascular access). The WRAPSODY CIE is designed to help clinicians restore vascular access in patients on hemodialysis who experience such obstructions. The study will evaluate the clinical outcomes in patients treated with the WRAPSODY CIE over three years. Omar Davis, M.D., president and medical director at Bluff City Vascular (Memphis) 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,” Dr. Davis said. “Participation in this registry is an important opportunity for us to assess the ability of this device to optimize hemodialysis care for our patients.”

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 (i.e., performance goals) of AVG patients treated with previous-generation covered stents.

“The WRAPSODY CIE’s ability to restore vascular access for patients on hemodialysis who experience obstructions is promising,” said David J. Dexter II, M.D., national principal investigator of the WRAP North America registry and vascular surgeon at Sentara Health Research Center in Norfolk, Va. “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.”

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.

“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,” Merit Chairman/CEO Fred P. Lampropoulos stated. “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.”

Real-world outcomes associated with WRAPSODY CIE use are also being evaluated in the WRAP Global registry (being conducted by Merit as well), 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.

On Dec. 19, 2024, the WRAPSODY CIE received U.S. Food and Drug Administration premarket approval. 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.

Founded in 1987, Merit Medical Systems Inc. develops, manufactures, and distributes proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide.