Merit Medical Systems Inc. Launches Groundbreaking PREEMIE Study for Premature Infants

Merit Medical Systems, Inc. (NASDAQ: MMSI), a prominent player in healthcare technology, has announced a significant milestone with the enrollment of the first patient in its multicenter, prospective PREEMIE study. This groundbreaking study is set to evaluate the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants, a condition that poses serious health risks to this vulnerable population.

Patent ductus arteriosus is a congenital heart defect that occurs when the ductus arteriosus—a crucial blood vessel connecting the aorta and pulmonary artery—fails to close after birth. This condition is particularly prevalent among premature and low-birth-weight infants, affecting normal blood flow to the lungs. A hemodynamically significant PDA (hsPDA) can lead to severe complications, necessitating timely intervention to close the opening. Current treatment options have expanded to include minimally invasive procedures, reducing the need for surgery and the delays associated with watchful waiting.

Merit’s Bloom Micro Occluder System represents an innovative approach to treating hsPDA through a minimally invasive technique. The device employs a flexible delivery system that is inserted via blood vessels to place a self-expanding nitinol device at the heart, effectively blocking blood flow through the PDA. Designed specifically for small patients, the Bloom system aims to streamline procedural steps and enhance the safety and efficacy of treatment.

The PREEMIE study will enroll at least 55 premature infants weighing between 600 g and 2,500 g across up to ten U.S. study sites. The study aims to assess both the safety and efficacy of the Bloom Micro Occluder System over a six-month period as part of a premarket approval application.

Dr. Howaida G. El-Said, MD, PhD, the Director of the Cardiac Catheterization Laboratory at Rady Children’s Hospital in San Diego and the National Principal Investigator of the PREEMIE study, commented on the significance of this research. “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,” Dr. El-Said stated. She emphasized that Bloom’s versatile and softer device design could enable safer and more effective care for these fragile patients.

Echoing this sentiment, Dr. Thomas J. Forbes, MD, Chief of Pediatric Cardiac Services at Joe DiMaggio Children’s Hospital, remarked, “Options for transcatheter device closure of PDA are limited. This study is a potential game changer for pediatric interventional cardiologists, allowing us the option to more reliably perform procedures at bedside.”

Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer, highlighted the company’s dedication to addressing unmet medical needs. “At Merit, we strive to help our physician partners resolve unmet needs of their patients,” he said. “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 classified as an Investigational Device Exemption (IDE) study, and the Bloom Micro Occluder System is not yet approved for treating PDA. As the research progresses, Merit aims to provide ongoing updates and information about the study, which can be found on their clinical trials page.

With the enrollment of the first patient, Merit Medical Systems is poised to make significant strides in the treatment of PDA, offering hope to countless families and healthcare providers dedicated to improving the lives of premature infants.