PREEMIE Trial Targets PDA Closure with Minimally Invasive Device
Merit Medical Systems has enrolled the first patient in its PREEMIE study, evaluating the Bloom micro occluder system for treating hemodynamically significant patent ductus arteriosus (hsPDA) in premature infants.
The Bloom system offers a minimally invasive alternative to traditional PDA treatment by delivering a self-expanding nitinol device via a flexible catheter to close the PDA through the blood vessels, avoiding surgery or delayed intervention.
The FDA IDE study will enroll at least 55 infants across 10 U.S. sites, assessing safety and efficacy over six months to support a premarket approval application.
“PREEMIE represents a critical step toward improving outcomes for vulnerable newborns,” said Fred P. Lampropoulos, Merit’s Chair and CEO.
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