PREEMIE: Study for Treatment of PDA in Premature Infants

Multicenter, Single Arm Prospective, Non-Randomized Study 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 (PREEMIE)

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.

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.