Percutaneous Transcatheter Occlusion Device Approved for PDA Closure

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The Amplatzer Piccolo Occluder is the first medical device that can be implanted in infants weighing as little as 2 pounds.
The Amplatzer Piccolo Occluder is the first medical device that can be implanted in infants weighing as little as 2 pounds.

The Food and Drug Administration has approved the Amplatzer Piccolo Occluder (Abbott), a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

The pea-sized device is a self-expanding wire mesh that is inserted through an incision in the leg and guided through vessels to the heart, where it is placed to seal the opening; it may be delivered via an anterograde (venous) or a retrograde (arterial) approach. The device is intended for use in infants >3 days old at time of procedure who may be non-responsive to medical management and who may not be able to undergo corrective surgery. The approval was supported by the ADO II AS study which included 50 patients with a PDA, with additional safety and efficacy data obtained from patients treated with the device under a continued access protocol.

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"This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive," said Evan Zahn, MD, director of the Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute, and principal investigator for the study that led to FDA approval.

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The safety and efficacy of the device is further supported by additional experience with the device under a continued access protocol involving 150 more patients. 
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