AGA Medical Receives Japanese Approval for AMPLATZER(R) Duc...( MINNEAPOLIS Jan. 7 /- AGA Medical...),Health

MINNEAPOLIS, Jan. 7 /PRNewswire/ -- AGA Medical Corporation ("AGA Medical") announced today that it received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its AMPLATZER(R) Duct Occluder (ADO). The ADO is a percutaneous, transcatheter occlusion device used for the non-surgical closure of patent ductus arteriosus (PDA), a common type of congenital heart defect that occurs when a blood vessel known as the ductus arteriosus fails to close after birth, as it normally should.

"We are very pleased to achieve this regulatory and commercial milestone in Japan," said John Barr, President and CEO of AGA Medical. "Our exclusive distribution partner, Japan Lifeline Co., Ltd., will immediately apply for reimbursement and intends to launch the product to the market in the first half of 2009 following receipt of reimbursement."

The ADO is the second AGA Medical device to receive approval in Japan. The company's AMPLATZER(R) Septal Occluder (ASO) was previously approved in 2005 and launched in May 2006. All medical devices in Japan must receive reimbursement approval prior to marketing of the product.

The ADO is intended for the closure of PDAs larger than 4 millimeters, which represent approximately 30 percent of total PDA defects. Uniquely shaped to achieve consistent, effective closure, the device is made of self-expanding nitinol mesh and is designed to be introduced in a minimally invasive fashion through a catheter. The ADO employs a retention "skirt," which allows the device to be positioned properly and remain in place at the entrance to the duct. Additionally, the device leverages the proven fully retrievable and repositionable screw technology platform used in all AGA Medical devices, which provides physicians with simple, controlled and precise delivery, ensuring a customized fit for each individual patient's anatomic structure.

The AMPLATZER Duct Occlud
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