The World’s First Medical Device for the Tiniest Babies with a Common Heart Defect

Airing: Episode 484, Week of Saturday March 9, 2019

The FDA recently approved the world’s first medical device that can be implanted in the tiniest babies weighing as little as two pounds. It’s done by using a minimally invasive procedure to treat a common heart defect.

Nearly 60,000 premature babies are born every year in the US and one out of five have a significant life-threatening opening in the heart. The world’s first and only Abbott piccolo device has been recently approved by the FDA, specifically for premature babies. PDA is a large vessel and it’s a little white structure that connects what are supposed to be separate circulations, the circulation that feeds our body and the circulation that feeds our lung.

Most of the babies actually have to be put on a ventilator or respirator because the effect of the PDA is that it’s really flooding their lungs with extra blood, and these are already premature small lungs that aren’t quite there. This can be treated in a very easy safe fast minimally invasive manner, where you end up with just a bandaid on your leg at the end of the day. Within hours and certainly within a day everything changes the prognosis, the outlook was all quite remarkable, so it’s a very simple procedure.

It’s done through a tiny pinhole in the groin like  many cardiac catheterizations and a catheter winds that up through the heart, watching it on TV. Then the piccolo device is a self expanding very soft mesh made of memory wire that delivers it directly into the PDA like a plug. One of the beauties of this device is if it’s not absolutely perfect there is the ability to withdraw the device and choose a different size or a different way to implant it. It stays in there for life, immediately after.