Merit Medical's WRAPSODY Endoprosthesis Receives FDA Approval for Dialysis Patients
Key Insights
Merit Medical (search)'s WRAPSODY Cell-Impermeable Endoprosthesis (search) receives FDA premarket approval, paving the way for its commercial launch in the U.S. in 2025.
The WRAPSODY device is designed to extend long-term vessel patency in dialysis patients by addressing stenosis (search) and thrombosis (search) in arteriovenous (AV) fistulas and grafts.
Clinical trial results from the WRAPSODY WAVE pivotal trial demonstrated high target lesion primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months.
Merit Medical (search) Systems, Inc. (NASDAQ: MMSI) has announced that its WRAPSODY Cell-Impermeable Endoprosthesis (search) received premarket approval from the U.S. Food and Drug Administration (FDA). This approval allows Merit Medical to commercialize the device in the United States starting in 2025, offering a new solution for dialysis patients facing vascular access complications.
The WRAPSODY endoprosthesis is specifically designed to prolong vessel patency in patients undergoing hemodialysis. These patients often rely on arteriovenous (AV) fistulas or AV grafts for vascular access, which are susceptible to stenosis (search) (narrowing of the vasculature) and thrombosis (search) (blood clot formation). Maintaining adequate blood flow through these access sites is crucial for the efficacy of dialysis and patient survival.
Addressing Stenosis and Thrombosis in Dialysis Access
Each year, approximately 687,000 procedures are performed in the United States to maintain dialysis access, with nearly 100,000 involving stent placement. While covered stents have improved long-term patency, stenosis (search) remains a common issue due to tissue accumulation within the polytetrafluoroethylene (PTFE) layer of these devices. To combat this, Merit Medical (search) collaborated with Dr. Bart Dolmatch to develop the WRAPSODY Cell-Impermeable Endoprosthesis (search), which features a unique cell-impermeable layer designed to prevent tissue migration.
According to Dr. Dolmatch, co-inventor of the WRAPSODY device, "Preserving vascular access for dialysis patients is critical for them to maintain lifesaving treatment. I believe the advancements that the WRAPSODY device offers will translate to better outcomes for hemodialysis patients."
Device Design and Clinical Trial Results
The WRAPSODY Cell-Impermeable Endoprosthesis (search) comprises a nitinol stent frame enveloped by an expandable PTFE outer layer, an inner-luminal layer of spun PTFE to reduce platelet and fibrin formation, and a middle cell-impermeable layer. The nitinol frame provides radial force, compression resistance, and softened ends to conform to vessels and reduce stress on vessel walls.
The WRAPSODY WAVE pivotal trial demonstrated promising results, with AV fistula and AV graft patients achieving target lesion primary patency rates of 89.8% and 82.0%, respectively, at six months. Furthermore, the primary patency of the entire access circuit at six months was 72.6% for AV fistula patients and 68.8% for AV graft patients.
Dr. Mahmood K. Razavi, Co-Principal Investigator of the WAVE trial, noted, "Historically, interventions for patients who experience a stenosis (search) in their AV fistula or AV graft have not provided sustained clinical benefits and often require multiple re-interventions. Results from the WAVE trial have demonstrated that the WRAPSODY device is associated with high patency rates and is likely to become the new standard of care."
Future Plans
Merit Medical (search) plans to host an informational conference call on January 28, 2025, to discuss the commercial opportunity presented by the WRAPSODY device. The company aims to provide physicians with an innovative solution that delivers improved outcomes for dialysis patients.