First Patient Enrolled in Merit Medical’s PREEMIE Study
Multicenter, prospective study designed to evaluate safety and efficacy of Bloom™ Micro Occluder System for treatment of patent ductus arteriosus in premature infants
SOUTH JORDAN, Utah, March 10, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced enrollment of the first patient in its multicenter, prospective study of the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in premature infants (PREEMIE study).
PDA is a congenital heart condition that occurs when the ductus arteriosus, a blood vessel connecting the aorta and pulmonary artery, does not close following birth. The condition is common in premature, low-birth-weight infants. A PDA affects the way blood flows through a baby’s lungs. A hemodynamically significant or large PDA (hsPDA) can negatively affect a baby’s health and require treatment to close the opening. Today, minimally invasive treatment options offer alternatives to surgery or delayed treatment after watchful waiting.
Merit’s Bloom Micro Occluder System was designed to be a minimally invasive option for treating hemodynamically significant PDAs. Bloom uses a flexible delivery system that is inserted through the blood vessels to deliver a small self-expanding nitinol device to the heart of the patient to block blood flow through the PDA. Bloom’s short flexible delivery system is designed for small patients and to streamline procedures by reducing procedural steps. The PREEMIE study has been developed to evaluate the safety and efficacy of the Bloom Micro Occluder System. Merit proposes to enroll at least 55 premature infants with hsPDA at up to ten U.S. study sites. To be eligible, patients must weigh between 600 g and 2,500 g, which are considered “extremely low birth weight” and “low birth weight,” respectively. Merit intends to evaluate safety and efficacy through six months as part of the premarket approval application.
“As there is currently no approved device for PDA in premature infants as small as 600 grams, we believe this study will provide critical information for treating this high-risk population,” said Howaida G. El-Said, MD, PhD, Director of the Cardiac Catheterization Laboratory at Rady Children’s Hospital in San Diego, CA, and National Principal Investigator of the PREEMIE study. “Bloom’s versatile and softer device design may enable safer and more effective care for these fragile patients.”
“Options for transcatheter device closure of PDA are limited,” said Thomas J. Forbes, MD, Chief of Pediatric Cardiac Services at Joe DiMaggio Children’s Hospital in Hollywood, FL, and one of the investigators in the PREEMIE study. “This study is a potential game changer for pediatric interventional cardiologists, allowing us the option to more reliably perform procedures at bedside.”
“At Merit, we strive to help our physician partners resolve unmet needs of their patients,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We look to the PREEMIE study to have a critical role in improving care for many vulnerable premature infants who would benefit from closure of their PDA using a transcatheter device.”
The PREEMIE study is an Investigational Device Exemption (IDE) study. The Bloom Micro Occluder System is not currently approved to treat PDA. For additional information on the PREEMIE study, including ongoing updates, please visit: /study/NCT06587282.
ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide.
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