A pea-sized device used to seal tiny but potentially deadly holes in the hearts of premature infants has been approved by U.S. regulators, making it one of the smallest complex medical devices ever invented and cleared for sale.
Abbott Laboratories’ Amplatzer Piccolo Occluder is one of the first treatments to become available for a common congenital defect that can become dangerous for premature infants. The device can be used in babies weighing as little as two pounds in cases where a hole in the heart used to deliver oxygen-rich blood in the womb doesn’t close after birth.
The Piccolo is threaded into the heart using a catheter that runs through the femoral vein in the thigh. That avoids a taxing surgery for the undersized patients, who are often on ventilators, said Evan Zahn, director of the congenital heart program at Cedars-Sinai Smidt Heart Institute in Los Angeles.
“We’ve never had anything like this, a device from a major medical manufacturer that was specifically designed with these tiny, really at risk, very fragile babies in mind,” said Zahn, the lead investigator of the study that led to the device’s approval by the U.S. Food and Drug Administration Monday. “We’re talking about babies the size of the typical water bottle we all drink out of. They are incredibly frail, fragile and at risk for terrible morbidity and mortality.”
The Piccolo is not expected to be a major sales driver for the Abbott Park, Illinois-based company. Instead, it represents a significant technological advance as medical-device manufacturers work to make their products ever smaller and easier to place in the body without taxing surgeries.
Everyone is born with a small hole in their heart, a condition called patent ductus arteriosus. In the womb, the hole allows a fetus’s blood to bypass the lungs and get oxygenated blood directly from the mother.
Usually, the hole closes a few days after delivery. In some premature newborns, however, it never does, making breathing difficult and leading to a host of potential complications. They include developmental delays, damage to the brain and bowel because they aren’t receiving the blood they need and injuries to the lungs that are flooded with fluid.
For years doctors performed open-heart surgery to close the hole, a procedure now thought to do more harm than good to the smallest patients, Zahn said. Other treatments include medicine to ease the symptoms and encourage closure, though in most cases doctors, patients and families simply wait and hope the hole eventually seals.
“We know it’s there and we know it’s bad, but we have to bite the bullet and hope the kids pull through,” Zahn said of existing medical practice.
The company hasn’t yet announced a price for the Piccolo.
News This Week
Modern Approaches to Augmentation of Brain Function Available from Springer Press This book covers recent advances in neural technology that provide for enhancements for brain function. It addresses a broad range of neural phenomena [...]
Although the currently available COVID-19 vaccines are highly effective, limited manufacturing capacity and the need for cold-chain storage hinder their global distribution. A recent study tested the efficacy of a new adeno-associated virus (AAV) [...]
Fully vaccinated people were 11 times less likely to die of COVID and 10 times less likely to be hospitalized compared to the unvaccinated since highly contagious Delta became the most common variant, US [...]
The highly-infectious Delta coronavirus variant has spread to at least 174 countries worldwide, from the US to Australia, causing a surge in COVID-19 cases. The variant has mutations that help it partially escape the immune response produced by [...]
Fragile mRNA molecules used in COVID-19 vaccines can’t get into cells on their own. They owe their success to lipid nanoparticles that took decades to refine. Messenger RNA (mRNA) is having a moment. This [...]
The COVID-19 pandemic has revealed critical knowledge gaps and assumptions concerning how respiratory viruses spread between hosts. Traditionally thought to be spread mainly through large respiratory droplets produced by the coughs and sneezes of sick individuals, [...]
SARS-CoV-2 is just one of nonillions of viruses on our planet, and scientists are rapidly identifying legions of new species. Mya Breitbart has hunted novel viruses in African termite mounds, Antarctic seals and water [...]
As a team of South African researchers we have identified a new lineage of SARS-CoV-2, the virus causing COVID-19. A lineage represents a genetically distinct virus population with a common ancestor. This virus may be designated as a variant [...]
Citing the possibility of another serious pandemic, the Biden administration on Friday laid out a plan to transform the nation’s ability to respond to major biological threats. As staggering as the COVID-19 pandemic has been, [...]
How doctors can predict which patients are more likely to die of COVID Several studies have come out about the COVID prognosis. As a result, we now have a powerful way to predict [...]
Though Delta continues to be the dominant COVID-19 strain, the World Health Organization (WHO) now says there's a new variant to keep your eye on. The B.1.621 variant, also called Mu, has just been [...]
Being fully vaccinated against Covid-19 not only cuts the risk of catching it, but also of an infection turning into long Covid, research led by King's College London suggests. It shows that in the [...]
Moderna Inc.’s Covid vaccine generated more than double the antibodies of a similar shot made by Pfizer Inc. and BioNTech SE in research directly comparing immune responses to the inoculations. A study of almost [...]
A coronavirus variant first detected in South Africa 'could be more infectious' than other mutations and have the potential to 'evade vaccines', scientists have said. The C.1.2 strain, which is linked to 'increased transmissibility', is more mutations away from [...]