Research & Development
Le Bonheur Children's Hospital successfully uses the Amplatzer Piccolo Occluder in the first premature PDA infant
8 February 2019 -

State-of-the-art hospital Le Bonheur Children's Hospital said on Thursday that its cardiologists have implanted the world's first commercially-approved medical device, the Amplatzer Piccolo Occluder, for transcatheter patent ductus arteriosus (PDA) closure in the tiniest babies (weighing as little as two pounds).

The Amplatzer Piccolo Occluder, which was developed by the healthcare company Abbott, is a self-expanding, wire mesh device inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening of the heart. The Piccolo device is smaller than a pea and 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.

In conjunction, Dr Shyam Sathanandam, MD, medical director of Le Bonheur's Interventional Cardiac Imaging and Interventional Catheterization Laboratory, helped pioneer the transcatheter closure before joining an eight site US FDA-approved trial for the Amplatzer Piccolo Occluder used in the closure.

Additionally, Shyam and his team closed the PDA in the first patient post-approval, a two week old baby girl, born at 28 weeks and weighing one kilogram. Le Bonheur enrolled more neonates than any other center in the study.

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