Abstract:

Introduction: half-year data on results of using new domestic NanoMed devices for closing atrial septal defects (ASD) were obtained. The occluder is a nitinol self-expanding and self-centering double disc device with a polyester membrane.

Aim: was to evaluate the safety and efficacy of a new domestic occluder for closing of atrial septal defect in a small group of patients over a 6-month follow-up period.

Material and methods: four pediatric patients underwent closure of atrial septal defects with domestic NanoMed occluders. Clinical examination and transthoracic echocardiography were performed at 24 hours, 1, 3, and 6 months. Endpoints included technical success of intervention, efficacy and safety of the procedure at follow-up instrumentation and physical examination.

Results: the average age of patients was 5,2 years (range 4 to 7 years). Mean ASD diameters and device waist sizes were 11,9 ± 1,2 mm and 13,7 ± 1,2 mm and 13,7 ± 1,2 mm, respectively. Technical and procedural success achieved in 100% of cases. During the six-month follow-up, no adverse events and residual flows were identified.

Conclusion: initial half-year data on the absence of adverse events and residual flows indicate the safety and effectiveness of the use of NanoMed occluders.

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