Merit Medical Systems announced positive six and twelve-month results from the randomized arm of its WAVE trial, studying the WRAPSODY Covered Intermittent Endovascular Stent System (CIE) for patients on hemodialysis with venous outflow stenosis. The WRAPSODY CIE showed significantly higher patency rates compared to standard percutaneous transluminal angioplasty (PTA) at both time points. The findings are set to be published in •Kidney International• and presented at the Society of Interventional Radiology’s 50th Annual Scientific Meeting.
These results are crucial for patients with end-stage renal disease requiring hemodialysis. Maintaining functional vascular access is a constant challenge for these patients, and stenosis often leads to repeated interventions. The WRAPSODY CIE’s demonstrated ability to significantly improve both target lesion and access circuit primary patency rates could translate to fewer re-interventions, improved quality of life, and potentially reduced healthcare costs associated with access maintenance. This offers clinicians a more effective tool for preserving long-term vascular access, a vital lifeline for these individuals.
The WAVE trial, a multicenter, international study, involved 245 patients randomized to receive either the WRAPSODY CIE or PTA. At six months, the WRAPSODY CIE achieved 89.8% target lesion primary patency and 72.6% access circuit primary patency, compared to 62.8% and 57.9% for PTA, respectively. These positive results continued at twelve months, with the WRAPSODY CIE maintaining significantly higher patency rates: 70.1% target lesion primary patency and 58.1% access circuit primary patency, versus 41.6% and 34.4% for PTA. No significant difference in safety outcomes was observed. The WRAPSODY CIE received FDA premarket approval in December 2024 and is currently being commercialized in the United States, having previously received the CE Mark for use in the European Union and Brazil.
The strong one-year data from the WAVE trial reinforces the potential of the WRAPSODY CIE to become a preferred treatment option for patients on hemodialysis with venous outflow stenosis. This positive clinical data, coupled with regulatory approvals, positions Merit Medical to gain market share and positively impact the treatment paradigm for this patient population. Continued monitoring of long-term outcomes and real-world data will be crucial in further solidifying the device’s role in vascular access maintenance.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
