Merit Medical's WRAPSODY Trial Yields Positive Results

1 min read | September 19, 2024 10:16 AM AEST | By Team Kalkine Media

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Merit Medical's WRAPSODY Trial Yields Positive Results — Image source: Shutterstock

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Merit Medical Systems reported positive 6-month outcomes from the WRAPSODY trial's arteriovenous (AV) fistula arm.
The trial data, presented at the Cardiovascular and Interventional Radiological Society of Europe, supports the company's Premarket Approval application to the FDA.
WRAPSODY, a cell-impermeable endoprosthesis, is already available in Europe and Brazil, and the trial results build on earlier successful studies.

Merit Medical Systems, Inc. (NASDAQ:MMSI) has unveiled encouraging 6-month data from the arteriovenous (AV) fistula arm of its pivotal WRAPSODY Arteriovenous Access Efficacy (WAVE) trial. This promising information was shared at the Cardiovascular and Interventional Radiological Society of Europe conference.

The WAVE trial focuses on assessing WRAPSODY, a cell-impermeable endoprosthesis designed to maintain vessel patency in dialysis patients. This new data enhances the findings from the initial WRAPSODY FIRST study, which was the first-in-human trial of this technology. These results are integral for the company's application for Premarket Approval with the FDA. Currently, WRAPSODY is approved and utilized in Europe and Brazil, and the latest trial data further supports its efficacy and safety.

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