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, e.g., valvular atresia,Tetralogy of Fallot, atrial septal defect, ventricular septal defect, transpositionof the great vessels, etc.

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