PREEMIE: Study for Treatment of PDA in Premature Infants

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 diseaseconditions at time of enrollment requiring intervention

• Subject has an active systemic infection at the time of enrollment.