Merit Medical Systems (Nasdaq:MMSI) announced today that investigators enrolled the first patient in a study of its Bloom micro occluder system.
The PREEMIE study evaluates the Bloom system for treating patent ductus arteriosus (PDA) in premature infants. A hemodynamically significant or large PDA (hsPDA) can negatively affect a baby’s health and require treatment. According to the company, minimally invasive treatment options offer alternatives to surgery or delayed treatment after watchful waiting.
Merit designed Bloom as a minimally invasive option for these PDAs, using a flexible delivery system. Inserted through the blood vessels, it delivers a small, self-expanding nitinol device to the heart of the patient. This, in turn, blocks blood flow through PDA.
PREEMIE, an FDA investigational device exemption (IDE) study, will evaluate the safety and efficacy of the Bloom micro occluder system. The company expects to enroll at least 55 premature infants with hsPDA at up to 10 U.S. study sites. Merit intends to evaluate safety and efficacy through six months as part of an FDA premarket approval application.
“At Merit, we strive to help our physician partners resolve unmet needs of their patients,” said Fred P. Lampropoulos, Merit Medical chair and CEO. “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.”
