Percutaneous Closure of the Patent Ductus Arteriosus in Very Low Weight Infants: Considerations Following US Food and Drug Administration Approval of a Novel Device
The Amplatzer Piccolo Occluder (or Amplatzer duct occluder II-additional sizes, ADO-II AS, Abbott, Chicago, Illinois) was approved by the US Food and Drug Administration on January 11, 2019.1 The class III device is indicated for percutaneous (catheter-based) closure of a patent ductus arteriosus (PDA) in an infant wei ghing>700 grams and a postnatal age of>3 days. After this regulatory approval, the healthcare community is tasked with answering fundamental questions on the appropriate use of the device in a subgroup of highly vulnerable patients.
Source: The Journal of Pediatrics - Category: Pediatrics Authors: Carl H. Backes, Regan E. Giesinger, Brian K. Rivera, Darren P. Berman, Charles V. Smith, Clifford L. Cua, Kelly J. Kelleher, Patrick J. McNamara, Jonathan L. Slaughter Tags: Commentary Source Type: research
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