Abbott's Amplatzer Piccolo Occluder Approved to Treat Patent Ductus Arteriosus in Premature Babies and Newborns
January 14, 2019—Abbott Structural Heart announced that the FDA has approved the company's Amplatzer Piccolo occluder, which can be implanted in very small babies (weighing as little as 2 lbs) using a minimally invasive procedure to treat patent ductus arteriosus (PDA). The Amplatzer Piccolo occluder offers corrective treatment for premature infants and newborns who may be nonresponsive to medical management and at high risk to undergo corrective surgery.
The Amplatzer Piccolo occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and is designed to allow the physician to insert it through the aortic or pulmonary artery, as well as to retrieve and redeploy the device for optimal placement.
FDA approval of the Amplatzer Piccolo occluder device was supported by ADO II AS, the United States pivotal trial that enrolled 50 patients with a PDA who were older than 3 days at eight centers. The safety and efficacy of the device are further supported by additional experience with the device under a continued access protocol involving 150 more patients.
Evan Zahn, MD, serves as principal investigator for the study that led to FDA approval. Dr. Zahn is Director of the Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute in Los Angeles, California. In the company's announcement, Dr. Zahn commented, "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."