NEW DELHI — Global healthcare company Abbott has launched its Amplatzer Piccolo Occluder in India. It is the world’s first medical device that can be implanted in the tiniest babies (weighing as little as 1.5 pounds) using a minimally invasive procedure to treat patent ductus arteriosus.
The device, smaller than a pea, will prove helpful for premature infants and newborn babies who need corrective treatment and who may be non-responsive to medicine and are at high risk of undergoing corrective surgery.
One of the most common congenital heart defects occurring in premature babies — patent ductus arteriosus — is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in typically developing fetuses, is essential before 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 patent ductus arteriosus fails to spontaneously close, making it difficult for babies to breathe normally due to increased blood flow to the lungs.
Patent ductus arteriosus accounts for up to 10 percent of all congenital heart disease.
“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,” said Payal Agrawal, General Manager, Abbott’s Structural Heart business in India and the Subcontinent.
Approximately 3.5 million premature babies are born in India each year with very low birth weight. The incidence of patent ductus arteriosus ranges from 15 percent to 37 percent in newborn babies weighing less than 3.8 pounds.
Overall, patent ductus arteriosus constitutes 5-10 percent of all congenital heart defects, with a prevalence of “symptomatic” patent ductus arteriosus being 5 per 10,000 live births. This indicates that the patent ductus arteriosus is large and causes symptoms, and will require treatment for the baby to survive.
“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.
“This is an excellent pre-loaded device, which means it does not need much preparation and has a softer profile that is easy to deploy. It has more variety in terms of size and is, therefore, suitable for babies of different ages and weight.”
A tiny infant, born at 27 weeks in the southern state of India, Kerala, was just 2 pounds. A test revealed he had patent ductus arteriosus, and he was intubated for almost a month. That is when Francis decided Abbott’s device was the best solution for the baby and decided to move forward with the implant.
“It was heart-warming for our entire team to see the baby turn a corner, get extubated, and put on some weight,” said Francis. “The device really fills a need for the smallest of our patients.”
The Amplatzer Piccolo Occluder 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 in the heart.
It is designed to allow the physician to insert it through the aortic or pulmonary artery and retrieve and redeploy the device for optimal placement.
Patent ductus arteriosus, if left untreated, the mortality rate of the disease is 20 percent by the age of 20 years, 42 percent by age 45 years, and 60 percent by the age of 60 years.
(With Inputs from ANI)
(Edited by Amrita Das and Saptak Datta)
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