MMSI Announces Commencement of Patient Enrollment in PREEMIE Study

Company Overview - Merit Medical Systems, Inc. (MMSI) has initiated the enrollment of the first patient in its multicenter, prospective PREEMIE study for the Bloom Micro Occluder System aimed at treating patent ductus arteriosus (PDA) in premature infants [1][2] - The Bloom Micro Occluder System is currently not approved for PDA treatment [1] Study Details - The PREEMIE study plans to enroll at least 55 premature infants with significant PDA across up to 10 U.S. study sites, targeting infants weighing between 600 g and 2,500 g [2] - The study will evaluate the safety and efficacy of the device over a six-month period as part of the premarket approval (PMA) application [2][4] Significance of the Study - PDA is a common congenital heart condition in premature infants, and the Bloom Micro Occluder System is designed as a minimally invasive treatment option [4] - An expert noted that there is currently no approved device for treating PDA in infants weighing 600 grams, making this study crucial for this high-risk population [5] Management Expectations - Merit Medical's management anticipates that the PREEMIE study will significantly enhance care for vulnerable premature infants who could benefit from PDA closure using a transcatheter device [6] Industry Prospects - The global PDA treatment market was valued at $2.4 billion in 2022 and is projected to reach $7.34 billion by 2030, growing at a CAGR of 15% [7] - The increasing demand for diagnostic tests and the rising incidence of PDA in infants are expected to drive market growth, positioning Merit Medical favorably within this niche [7] Recent Developments - Merit Medical reported robust revenue growth in its Cardiovascular unit in its fourth-quarter 2024 results [8] - The company received FDA PMA approval for the WRAPSODY Cell-Impermeable Endoprosthesis, allowing for commercialization in 2025 [8] - Positive six-month findings from the WAVE pivotal trial for the WRAPSODY device were also announced [9] Competitive Landscape - Boston Scientific Corporation (BSX) has entered into an agreement to acquire SoniVie Ltd. to expand its offerings in interventional cardiology [10] - AngioDynamics, Inc. (ANGO) has initiated a randomized study for the Auryon Atherectomy System [12] - Medtronic plc (MDT) released positive two-year results from the SMART Trial, showcasing its competitive position in the cardiovascular space [13]