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AGA Medical’s AMPLATZER Duct Occluder Receives Japanese Approval

AGA Medical Corporation announced that the company has received approval for its AMPLATZER Duct Occluder (ADO) from the Japanese Ministry of Health, Labour and Welfare (MHLW). The AMPLATZER device is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus (PDA). The ADO is the second AGA Medical device to receive approval in Japan. AMPLATZER Duct Occluder is designed to be used for the closure of PDAs larger than 4 millimeters, which represent approximately 30 percent of total PDA defects. The device is made of self-expanding nitinol mesh and is designed to be introduced in a minimally invasive fashion through a catheter to achieve consistent, effective closure. The ADO device utilizes a retention "skirt" that allows the device to be positioned properly and remain in place at the entrance to the duct. The retrievable and repositionable screw technology platform used in the device provides physicians with simple, controlled and precise delivery, ensuring a customized fit for each individual patient's anatomic structure.