This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects with patent ductus arteriosus (PDA) defects. Safety and efficacy assessments include vital signs, electrocardiograms, and echocardiographic evaluations performed at baseline/implantation (including assessments within 36 hours post procedure), as well as at follow up visits occurring between Day 30 and Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation.
A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects.
Male or female subjects.
Subjects or their parents/guardians understanding the nature of the study and providing their informed consent to participation.
Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP.
Pulmonary Vascular Resistance (PVR) > 8 Wood Units
Presence of a known coagulation disorder
Thrombus at the position allocated for the implantation
A vein thrombosis in the blood vessels chosen for the introducing system