Nit-Occlud PDA Post-Approval Study

Nit-Occlud PDA Post-Approval Study

The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.

Inclusion Criteria:

• Angiographically confirmed PDA with minimum diameter < 4 mm.
• Weight is ≥ 5 kg.
• Age 6 months to 21 years.

Exclusion Criteria:

• Cardiac anomalies requiring surgery.
• Known bleeding or coagulation disorder.
• Febrile illness within 7 days of planned procedure.
• Pregnancy.
• Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
• Hypersensitivity to contrast medium.
• Known nickel allergy.