Merit Medical's Wrapsody Cell-Impermeable Endoprosthesis Receives FDA Pre-market Approval

Merit Medical Systems

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(RTTNews) - Merit Medical Systems, Inc. (MMSI), Friday announced that its Wrapsody Cell-Impermeable Endoprosthesis has secured premarket approval from the Food and Drug Administration, enabling its commercialization in the U.S. in 2025.

The device is designed to extend long-term vessel patency in dialysis patients, who rely on a vascular access site created in the arm called an arteriovenous or AV fistula or an AV graft.

As per the Wrapsody WAVE pivotal trial data, AV graft patients receiving treatment with the Wrapsody device for dialysis outflow lesions achieved a target lesion primary patency of 89.8 percent and 82.0 percent, respectively, at six months, the company stated.

Currently, Merit Medical's stock is trading at $98.40, up 2.22 percent on the Nasdaq.