First Patient Enrolled in Merit Medical's PREEMIE Study

Core Insights - Merit Medical Systems, Inc. has initiated a multicenter, prospective study named PREEMIE to evaluate the safety and efficacy of the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants [1][4] - The Bloom Micro Occluder System is designed as a minimally invasive treatment option for hemodynamically significant PDAs, utilizing a flexible delivery system to insert a self-expanding nitinol device [3][4] - The study aims to enroll at least 55 premature infants weighing between 600 g and 2,500 g across up to ten U.S. study sites, with a focus on assessing safety and efficacy over a six-month period [3][4] Company Overview - Merit Medical Systems, Inc. was founded in 1987 and specializes in the development, manufacture, and distribution of proprietary medical devices for interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy [5] - The company has a global presence with a sales force and clinical support team of over 800 individuals and employs approximately 7,400 people worldwide [5] Industry Context - Patent ductus arteriosus (PDA) is a common congenital heart condition in premature, low-birth-weight infants, which can negatively impact health and often requires treatment [2] - Current treatment options for PDA in small premature infants are limited, making the Bloom Micro Occluder System a potentially significant advancement in pediatric interventional cardiology [4]