Merit Medical Systems, Inc.
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population. Participants treated with the WRAPSODY CIE device in accordance with the device instructions for use will be followed in accordance with standard of care up to 3-years post-procedure.
Prospective, multicenter, observational study to evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit (WRAP North America)
Inclusion Criteria: 1. Subject provides written informed consent for study participation. 2. Subject is male or female, with an age ≥ 18 years at date of enrollment. 3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months. 4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon. 5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session. 6. Subject has stenosis or occlusion within the dialysis outflow circuit and i…
Target Lesion treated with WRAPSODY CIE