Evaluation of Safety and Effectiveness of the Floret™ PDA Occluder for Transcatheter Closure of Patent Ductus Arteriosus in PediatricPatients

Abstract

Background: Transcatherter closure of patent ductus arteriosus with PDA occluder is well-established procedure for the paediatric patients.Surgical closure of patent ductus arteriosus in paediatric patients may be problematic. Transcatheter closure of PDA using the PDA occluder has showed to be safe and effective compared to the previous methods. Objective: The purpose of this research is to assess the PDA occluder safety and efficacy in treating PDA in paediatric patient. Method:An analysis of the three cases of PDA patients treated with the PDA occluder is included in this case 2 females and 1 male with 9-12 years old. The procedure was performed under fluoroscopic guidance; angiography and clinical assessment of the patients were conducted before the procedure. Medical records follow up imaging and post procedure monitoring were used to evaluate a clinical result. Result:The PDA occluder successfully closed the patent ductus arteriosus in cases, with high success rate and no major complication. No recurrence of PDA was observed in patients. Transcatheter closure of PDA produced improvement of patient’s symptoms and signs post closure and also significant reduction in heart rate and respiratory rate. Conclusion:The PDA occulder is a safe and effective device for the closure of PDA in paediatric patients. In comparison to surgery the treatment offers a less invasive option with excellent long term outcomes. This result provide acceptance to the PDA occluder use as preferred treatment for patent ductus arteriosus, with potential to improve clinical outcomes and reduce recovery time.

Introduction

Patent Ductus Arteriosus (PDA) is a common congenital heart defect where the ductus arteriosus—a vessel connecting the aorta and pulmonary artery—fails to close shortly after birth. This results in abnormal blood flow that can strain the heart and lungs, potentially causing heart failure, pulmonary hypertension, and other complications if untreated. PDA is most prevalent in premature infants, with symptoms ranging from rapid breathing and feeding difficulties to poor growth.

Traditional treatments include medications like ibuprofen or indomethacin, which encourage closure, and surgical ligation, which is invasive and has longer recovery times. Advances in interventional cardiology favor transcatheter closure using occluder devices as a safer, minimally invasive, and cost-effective alternative. Devices such as the Floret™ PDA Occluder by Meril Life Sciences have demonstrated high success rates and good biocompatibility in preclinical studies.

Historically, PDA closure evolved from surgical ligation to catheter-based techniques over the past decades, with modern occluders achieving excellent outcomes and becoming the standard treatment for children and adults. Simulation tests confirm the safety and effectiveness of these devices in positioning and occlusion without damage.

Overall, timely diagnosis and intervention with minimally invasive devices significantly improve prognosis, reducing complications and enabling children to lead normal lives with ongoing cardiac monitoring.

Conclusion

Percutaneous Transcatherter PDA occlusion in preterm infants is feasible and showed positive short –term and long-term effects, the transcatheter closure of patent ductus arteriosus results in marked improvement of clinical and hemodynamic status of the patient. Percutaneous closure of PDA show is safe and effective procedure achieving high occlusion rate in younger population with small to moderate size of patent ductus arteriosus with no complications. The findings from our study showed that Transcatheter closure of PDA with PDA occluder was very efficient and safe when used inPediatric patients with excellent and satisfied short-term, mid-term and long term results. The minimal incidence of complications and residual shunts makes this device ideal for the Transcatheter closure of patent ductus arteriosus in pediatric patients..

References

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Copyright

Copyright © 2025 Minocha Dr. Pramod Kumar, Kothwala Dr. Deveshkumar, Shah Khusboo, Machhi Diya, Bhatia Rajni, Patel Krushang. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.