"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® 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 Occluder was granted Conformite Europeenne (CE) Mark in Europe in February 1998 and U.S. Food and Drug Administration (FDA) approval in May 2003. AGA Medical’s second generation AMPLATZER Duct Occluder – ADO II – has been granted CE Mark approval in Europe and can be delivered through even smaller catheters and is appropriate for both smaller ducts and ducts with different geometries. AGA Medical has a clinical trial underway to support approval for the ADO II in the United States.
About Patent Ductus Arteriosus
The ductus arteriosus is an open channel in every fetus that allows blood to bypass the lungs, which are not used until the baby takes its first breath after birth. Shortly after the baby's first breath, the ductus arteriosus should close permanently. If it does not close, it is known as a PDA. This condition 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.
About AGA Medical Corporation
AGA Medical Corporation, based in Plymouth, Minnesota, is a leader in developing interventional devices for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease. Founded in 1995 by Dr. Kurt Amplatz, a former professor and researcher at the University of Minnesota Department of Radiology, AGA Medical develops and commercializes devices for a range of structural heart repair and circulatory conditions. Several of these devices have been major innovations in the treatment of the most common congenital "holes in the heart", such as atrial septal defects and patent foramen ovales.
More than 700 articles have been published in medical literature that support the benefits of AGA Medical devices, including improved patient outcomes, reduced length of stay, and accelerated recovery times for the patient. AGA Medical devices have received regulatory approval and are marketed in 101 countries. For more information, visit www.amplatzer.com.