Merit Medical ((MMSI)) announced an update on their ongoing clinical study.
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Study Overview: Merit Medical Systems, Inc. is conducting a prospective, multicenter, observational study titled ‘Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit (WRAP North America).’ The study aims to assess the safety and efficacy of the WRAPSODY CIE device in treating venous stenosis and occlusion in a real-world North American population, following participants up to three years post-procedure.
Intervention/Treatment: The intervention being tested is the Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE), a device designed to treat target lesions associated with venous stenosis and occlusion within the dialysis outflow circuit.
Study Design: This is an observational cohort study with a prospective time perspective. It is designed to observe the outcomes of the WRAPSODY CIE device in a real-world setting without any specific allocation or intervention model, focusing on the device’s real-world application and effectiveness.
Study Timeline: The study began on January 29, 2025, with the latest update submitted on September 29, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
Market Implications: This study could significantly impact Merit Medical’s stock performance and investor sentiment by potentially validating the efficacy of the WRAPSODY CIE device in a real-world setting. Success in this study may enhance Merit Medical’s competitive position in the medical device industry, particularly in the treatment of venous conditions.
The study is currently recruiting, with further details available on the ClinicalTrials portal.