Abbott launches Amplatzer Piccolo in India for treatment of heart defects in premature babies

Mumbai: Abbott on Tuesday announced that it has launched its Amplatzer Piccolo Occluder in India, the world's first medical device that can be implanted in the tiniest babies using a minimally invasive procedure to treat patent ductus arteriosus, or PDA.

The Amplatzer Piccolo 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. 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 respiratory support soon after the procedure.

"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 for Abbott's structural heart business in India and the Subcontinent. "We are passionate about developing life-changing technologies to help people, including vulnerable infants, live better lives. It is gratifying to know that through our devices, these children have a chance at a normal life and can live their fullest lives."

The Amplatzer Piccolo, a device even smaller than a pea now 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, said the company release.

"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 Dr. Edwin Francis, Senior Consultant, Head of Paediatric Cardiology Department, Lisie Hospital, Ernakulum. He further added, “This is an excellent pre-loaded device, which means it doesn’t 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.”

Approximately 3.5 million premature babies are born in India each year with a very low birth weight. The incidence of PDA ranges from 15% to 37% in newborn babies weighing less than 1750 gms. Overall, PDA constitutes 5%–10% 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 causes symptoms and will require treatment for the baby to survive.