FX.co ★ Merit Medical's Wrapsody Cell-Impermeable Endoprosthesis Receives FDA Pre-market Approval

Merit Medical Systems, Inc. (MMSI) announced on Friday that the FDA has granted premarket approval for its Wrapsody Cell-Impermeable Endoprosthesis, paving the way for its U.S. market launch in 2025. This device is specifically engineered to maintain long-term vessel patency for dialysis patients who require a vascular access point, such as an arteriovenous (AV) fistula or AV graft, typically in the arm. According to findings from the Wrapsody WAVE pivotal trial, patients with AV grafts treated for dialysis outflow lesions using the Wrapsody device achieved target lesion primary patencies of 89.8 percent and 82.0 percent at the six-month mark. Meanwhile, Merit Medical's shares are currently trading at $98.40 on the Nasdaq, reflecting a 2.22 percent increase.