Merit Medical ((MMSI)) announced an update on their ongoing clinical study.
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Study Overview: Merit Medical Systems, Inc. is conducting a study titled ‘Multicenter, Single Arm Prospective, Non-Randomized Study Designed to Evaluate the Safety and Effectiveness of the BLOOM™ Micro-Occluder System for the Treatment of Patent Ductus Arteriosus (PDA) in Pre-mature Infants (PREEMIE).’ The study aims to assess the safety and effectiveness of the Bloom Micro Occluder System in treating PDA in premature infants, a condition that can lead to serious health issues if left untreated.
Intervention/Treatment: The intervention being tested is the Bloom Micro Occluder System, a device designed for the percutaneous transcatheter closure of PDA. Its purpose is to provide a minimally invasive treatment option for this congenital heart defect.
Study Design: This is an interventional study with a single-group assignment. It is non-randomized and open-label, meaning there is no masking. The primary purpose of the study is treatment-focused, aiming to evaluate the device’s effectiveness in a real-world clinical setting.
Study Timeline: The study began on September 5, 2024, with its primary completion and estimated overall completion dates not yet specified. The latest update was submitted on August 6, 2025, indicating ongoing recruitment and progress.
Market Implications: This study update could positively impact Merit Medical’s stock performance by showcasing their commitment to innovative solutions in pediatric cardiology. Successful results may enhance investor confidence and position the company favorably against competitors in the medical device industry.
The study is currently ongoing, with further details available on the ClinicalTrials portal.
