PREEMIE: Study for Treatment of PDA in Premature Infants

Summary

This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.

Eligibility

Inclusion Criteria:

* Subject is age ≥5 days at time of enrollment.
* Subject has a diagnosis of a hemodynamically significant patent ductus arteriosus (PDA) requiring closure.
* Subject has a PDA is ≤4.0 mm in diameter.
* Subject has a PDA is ≥5 mm in length.
* Subject's weight is between 600-2500 grams at time of enrollment.

Exclusion Criteria:

* Subject has pre-existing coarctation of the aorta.
* Subject has pre-existing left pulmonary artery stenosis.
* Subject has an Intracardiac thrombus that may interfere with the implant procedure
* Subject has other known hemodynamically significant congenital heart disease conditions at time of enrollment requiring intervention
* Subject has an active systemic infection at the time of enrollment.

Conditions2

Locations10 sites

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