The study is anticipated to enrol a minimum of 55 premature infants with hsPDA across up to ten US study sites. Credit: BlueBoeing / Shutterstock.
Merit Medical Systems has enrolled the first patient in the multi-centre PREEMIE study to assess the efficacy and safety of the Bloom Micro Occluder System, aimed at treating patent ductus arteriosus (PDA) in premature infants.
PDA is stated to be a congenital heart condition where the ductus arteriosus, a blood vessel that links the aorta and pulmonary artery, fails to close after birth. This affects blood flow through the lungs.
A haemodynamically significant or large PDA (hsPDA) can have serious health implications for a baby, necessitating timely treatment for closing the opening, stated the company.
The system offers a minimally invasive solution, leveraging a flexible delivery system that is “inserted” for delivering a small self-expanding nitinol device to the individual’s heart to obstruct the flow of blood via the PDA.
Its short “flexible” delivery system is tailored for babies to simplify the medical procedure by decreasing the number of steps involved.
The study is anticipated to enrol a minimum of 55 premature infants with hsPDA across up to ten US study sites.
Eligibility criteria require patients to weigh between 600g and 2.5kg, categorising them as “extremely low birth weight” to “low birth weight.”
Merit noted that as a part of the premarket approval application process, it plans to monitor efficacy and safety for a six-month period.
The system is currently undergoing this investigational device exemption (IDE) study and is not yet approved for PDA treatment.
Merit Medical Systems CEO and chairman Fred Lampropoulos said: “At Merit, we strive to help our physician partners resolve unmet needs of their patients. 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.”
Merit focuses on developing medical devices for various procedures, including cardiology and oncology, employing nearly 7,400 individuals worldwide.
In December 2024, the company [gained premarket approval](https://www.medicaldevice-network.com/news/merit-medical-wrapsody-fda/) from the US Food and Drug Administration for its Wrapsody Cell-Impermeable Endoprosthesis setting the stage for a US commercial launch next year.