FDA approves world’s first device for treatment of premature babies and newborns with an opening in their hearts

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Abbott’s Amplatzer Piccolo Occluder device

The US Food and Drug Administration (FDA) has approved the Amplatzer Piccolo Occluder (Abbott), the world’s first medical device that can be implanted in babies weighing as little as two pounds using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery.

One of the most common congenital heart defects occurring in premature babies, PDA is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing foetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the foetus’ body. For most infants, the pathway, or duct, seals itself shortly after birth. In some cases, primarily in babies born prematurely, the PDA fails to spontaneously close, which can make it difficult for babies to breathe normally due to increased blood flow to the lungs. PDA accounts for up to 10 percent of all congenital heart disease.

Approximately 60,000 premature babies in the USA are born each year with a very low birth weight, and nearly 12,000 (one out of five) of these have a hemodynamically significant PDA—a PDA that is large and causes symptoms—which will require urgent treatment for the baby to survive.

The Amplatzer Piccolo Occluder is a self-expanding, wire mesh device that is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening in the heart. It 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. Because the device is deployed in a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit are able to be weaned from artificial respirator support soon after the procedure.

Born at 27 weeks, twin babies Irie and Judah Felkner of Columbus, USA, were both fighting for their lives in the neonatal intensive care unit when an echocardiogram revealed Irie had a PDA that required immediate treatment.

“The doctor thought Abbott’s Amplatzer Piccolo device was the best solution for Irie, and after learning more about the procedure we decided to move forward,” said Crissa Felkner, Irie’s mother. “You have to live it to fully appreciate what that device did for our daughter. Three days after the procedure, she was making great progress and is now a normal toddler with no limitations. The Abbott device was truly lifesaving for our daughter.”

The Felkner twins were treated as part of the US pivotal trial, ADO II AS, which helped to support the FDA approval of the device. The trial evaluated the Amplatzer Piccolo Occluder and enrolled 50 patients with a PDA who were older than three days at eight centres across the USA. 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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