Merit Medical Systems (MMSI) FDA Approvals

Merit Medical Systems' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Merit Medical Systems (MMSI). Over the past two years, Merit Medical Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as WRAPSODY. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

WRAPSODY FDA Regulatory Events

WRAPSODY is a drug developed by Merit Medical Systems for the following indication: Cell-Impermeable Endoprosthesis (CIE). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Enrollment Update - August 18,2025

• Drug: WRAPSODY
• Announced Date: August 18, 2025
• Indication: Cell-Impermeable Endoprosthesis (CIE).

Merit Medical Systems announced today the successful enrollment of the first patient in the WRAP North America registry.

Merit Medical Systems announced the first patient enrollment in its WRAP North America registry. The study will gather safety and effectiveness data on the WRAPSODY CIE, which restores vascular access in hemodialysis patients with vein narrowing or blockage. Enrollment began at Bluff City Vascular in Memphis.

The registry aims to enroll up to 250 patients in the U.S. and Canada, tracking outcomes over three years after treatment with the WRAPSODY CIE. Omar Davis, MD, Medical Director at Bluff City Vascular, said the registry offers a key opportunity to assess the device’s potential to optimize dialysis care.

David J. Dexter II, MD, National Principal Investigator, said evaluating the WRAPSODY CIE’s performance will guide its broader clinical use. Merit CEO Fred P. Lampropoulos called the first enrollment an important step in building robust evidence and advancing technology to improve dialysis care.

Merit Medical Systems FDA Events - Frequently Asked Questions

Has Merit Medical Systems received FDA approval?

As of now, Merit Medical Systems (MMSI) has not received any FDA approvals for its therapy in the last two years.

What drugs has Merit Medical Systems submitted to the FDA?

In the past two years, Merit Medical Systems (MMSI) has reported FDA regulatory activity for WRAPSODY.

What is the most recent FDA event for Merit Medical Systems?

The most recent FDA-related event for Merit Medical Systems occurred on August 18, 2025, involving WRAPSODY. The update was categorized as "Enrollment Update," with the company reporting: "Merit Medical Systems announced today the successful enrollment of the first patient in the WRAP North America registry."

What conditions do Merit Medical Systems' current drugs treat?

Currently, Merit Medical Systems has one therapy (WRAPSODY) targeting the following condition: Cell-Impermeable Endoprosthesis (CIE)..