Device for Closing Patent Ductus Arteriosus

The device has been cleared by the US Food and Drug Administration (FDA).

Called the Amplatzer Duct Occluder, the device was implanted in 435 patients in a clinical trial. Based on a one-year follow-up of 227 patients, the device was 100% effective in closing the PDA. PDA is normally diagnosed in newborns and young children but occasionally is discovered in adults. After birth, the ductus arteriosus normally closes, but in some cases, it stays open. This adversely affects circulation, causing symptoms that can include rapid breathing, chronic respiratory infections, and even heart failure and death.

Traditionally, open-chest heart surgery has been used to treat the condition. The Amplatzer Duct Occluder is designed to make placement easier and result in higher rates of occlusion while being less invasive. The device is self-expanding and implantable, and is made from super-elastic Nitinol wire mesh. A retention skirt secures positioning within the "mouth” of the ductus. The device is compressed inside a catheter and then introduced through a vein in the patient's groin. The device is the product of Aga Medical Corp. (Minneapolis, MN, USA).

"I love this device,” said Dr. Thomas M. Zellers, a cardiologist at Children's Medical Center of Dallas (TX, USA), who participated in the clinical trial. "It has had excellent total closure rates—100% in our hands. And it's easy to load and deploy.”




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