MERIT MEDICAL SYSTEMS, INC.

Merit Medical's WRAPSODY Endoprosthesis Receives FDA Approval for Dialysis Patients

5 months ago

• Merit Medical's WRAPSODY Cell-Impermeable Endoprosthesis 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 and thrombosis 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. • The device features a unique cell-impermeable design intended to prevent tissue accumulation, a key contributor to stenosis in hemodialysis patients.