Despite its simplicity device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospective non randomized multicenter study we investigated the safety and efficacy of the Cocoon Septal Occluder (CSO) for closure of atrial septal defects (ASDs) in 92 patients. Median age of the patient was 10.5 years (range 3-61years) and median weight was 25 kgs. The device is an improved new generation double disc design made of nitinol wire mesh that is coated with platinum using Nano Fusion Technology. The discs are connected by a waist with diameter ranging from 6 mm to 40 mm with 2 mm increments. All patients completed 3 months follow up. Mean ASD diameter was 21±7mm (range 10-35). While the mean device diameter was 24±8 mm (range 14-40mm). The CSO was permanently implanted in all 92 patients. Complete echocardiography closure of defect immediately after the procedure or at 1 month follow up was observed in all 92 patients. No device related complications were observed during the short term follow up (range 3-12months) . Our preliminary results indicate that CSO is a promising device for transcatheter closure of ASDs. Further studies are required to document its efficacy , safety and long term results in a large patient population .
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