News | January 06, 2009

AMPLATZER Duct Occluder Approved for Use in Japan

Janaury 7, 2009 - The Japanese Ministry of Health, Labour and Welfare (MHLW) granted approval to AGA Medical Corp. for its AMPLATZERDuct Occluder (ADO), a percutaneous, transcatheter occlusion device used for the non-surgical closure of a common structural heart defect known as patent ductus arteriosus (PDA).

PDA occurs when a blood vessel known as the ductus arteriosus fails to close after birth. PDA can cause symptoms such as fatigue, difficulty or rapid breathing, failure to grow normally, or chronic respiratory infections such as colds and pneumonia, or endocarditis. PDA can also be asymptomatic. Large openings can lead to heart failure and death.

The ADO is intended for the closure of PDAs larger than four millimeters, which represent approximately 30 percent of total PDA defects. The device is made of self-expanding nitinol mesh and is introduced in a minimally invasive fashion through a catheter. Its unique shape is designed to achieve consistent, effective closure. The ADO employs a retention "skirt," which allows the device to be positioned properly and remain in place at the entrance to the duct. The device also leverages the fully retrievable and repositionable screw technology platform used in all AGA Medical devices, which reportedly provides physicians with simple, controlled and precise delivery, ensuring a customized fit for each individual patient's anatomic structure.

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