Abbott launches pea-sized life-saving device for babies with hole in heart

The device is particularly useful for tiny babies who may not be able to undergo surgery to repair their hearts


Abbott | Abbott Healthcare

BS Reporter  | 

Global health care company Abbott has launched what it claims is the world’s first medical device that can be implanted in the tiniest of babies (weighing as little as 700 gm) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA.

Responding to an email query, the company said the launch is pan-India, with focus on centres have an active neonatal intensive care unit (NICU) with skilled pediatric interventional cardiologists.

In common parlance, the condition is known as ‘hole in the heart”.

The Amplatzer Piccolo Occluder, a device smaller than a pea, offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medicine and are at high risk to undergo corrective surgery, Abbott said in a release.

The 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, the release.

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.

Payal Agrawal, General Manager for Abbott’s Structural Heart business in India and the Subcontinent, was quoted in the press release as saying that Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts.

“This product is a potentially life-saving advance that will help us treat these delicate infants who might otherwise not be able to survive,” said Edwin Francis, Senior Consultant, Head of Paediatric Cardiology Department, Lisie Hospital, Ernakulum, who recently implanted this device in a premature baby weighing 960 grams.

He said, “It was heartwarming for our entire team to see the baby turn a corner, get extubated and put on some weight. The device really fills a need for the smallest of our patients.”

Francis says since the Occluder is a pre-loaded device, it doesn’t need much preparation, and has a softer profile that is easy to deploy. It comes in various sizes and is therefore suitable for babies of different ages and weight.

Approximately 3.5 million premature babies are born in India each year with a very low birth weight, according to a 2016 Central government report on premature births. Another study by the Department of Paediatrics, AIIMS-Delhi, says the incidence of PDA ranges from 15 per cent to 37 per cent in newborn babies weighing less than 1,750 gm.

Overall, PDA constitutes 5–10 per cent of all congenital heart defects with a prevalence of “symptomatic” PDA being 0.5/1000 live births. This means that the PDA is large and causessymptoms and will require treatment for the baby to survive.

One of the most common congenital heart defects occurring in premature babies, PDA is a life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing fetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus’ 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 per cent of all congenital heart disease.

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