Regulatory Focus™ > News Articles > 2019 > 1 > Abbott Snags FDA Approval for Neonatal Heart Device

Abbott Snags FDA Approval for Neonatal Heart Device

Posted 14 January 2019 | By Ana Mulero 

Abbott Snags FDA Approval for Neonatal Heart Device

Abbott obtained US Food and Drug Administration (FDA) approval for its pea-sized Amplatzer Piccolo Occluder.

This is the first medical device in the world to receive FDA approval for the treatment of patent ductus arteriosus (PDA) in premature babies and newborns weighing as little as two pounds, Abbott said Monday.

PDA is a potentially life-threatening opening between two blood vessels leading from the heart. Approximately 60,000 premature babies in the US are born each year with a very low birth weight and nearly 12,000 of these have a PDA that is large and causes symptoms that will require urgent treatment for the baby to survive

The self-expanding wire mesh device can be surgically implanted through an incision in the leg when this channel fails to close after birth. PDA in premature infants with low birth weight has been associated with “extremely high mortality rates,” research shows.  

The trial conducted to support the FDA approval involved 50 PDA patients who were older than three days across eight US centers. The agency evaluated the device through the premarket approval pathway, Abbott spokesperson Mary Kokkinen told Focus

The device builds on the years of the Amplatzer family’s clinical success, Abbott said. The product line belonged to St. Jude Medical prior to Abbott’s acquisition amid lawsuits brought on over risk to health.

Categories: Regulatory News

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