Merit Medical Systems announced today the successful enrolment of the first patient in the WRAP North America registry.
The WRAP North America registry is designed to enrol up to 250 patients from the USA and Canada on haemodialysis who experience obstructions, such as stenosis or occlusion in the veins requiring for dialysis. The WRAPSODY CIE is reportedly designed to help clinicians restore vascular access in patients on haemodialysis who experience such obstructions.
The study protocol provides for evaluation of clinical outcomes in patients treated with the WRAPSODY CIE over three years. Omar Davis, president and medical director at Bluff City Vascular in Memphis, USA and investigator in the WRAP North America registry, enrolled the first patient.
“We appreciate the ingenuity and novelty of the WRAPSODY CIE,” said Davis. “Participation in this registry is an important opportunity for us to assess the ability of this device to optimise haemodialysis 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 randomised arm, patients with an arteriovenous fistula (AVF) were treated with the WRAPSODY CIE or percutaneous transluminal angioplasty (PTA). In the non-randomised arm, clinical outcomes of patients with an arteriovenous graft (AVG) were compared to historical outcomes (e.g., performance goals) of AVG patients treated with previous generation covered stents.
“The WRAPSODY CIE’s ability to restore vascular access for patients on haemodialysis who experience obstructions is promising,” said David J Dexter II, national principal investigator of the WRAP North America registry and vascular surgeon at Sentara Health Research Center in Norfolk, USA. “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, so say the company in a recent press release. If completed as designed, it would reportedly represent the largest cohort of patients treated with an implantable device to restore vascular access for haemodialysis.
“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 Fred P Lampropoulos, Merit’s chairman and chief executive officer. “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 the use of the WRAPSODY CIE are also being evaluated in the WRAP global registry, also being conducted by Merit, which was designed to enrol up to 500 patients outside of North America. Final enrolment in the WRAP global registry is expected by the end of 2025.
