Abbott launches new device in India for treating pre-mature babies and newborns with openings in heart

Life-saving technology provides new optimally-sized treatment option to address critical need for the tiniest newborns, including pre-mature infants weighing even less than one kilogram

Abbott has launched its Amplatzer Piccolo Occluder in India, the world’s first medical device that can be implanted in the tiniest babies (weighing as little as 700 gms) using a minimally invasive procedure to treat patent ductus arteriosus (PDA), a company statement said.

It also mentioned that the Amplatzer Piccolo, a device even smaller than a small pea offers hope to pre-mature infants and newborns who need corrective treatment, and who may be non-responsive to medicine and are at high risk to undergo corrective surgery.

“Piccolo is a critical advancement in the standard of care for the most vulnerable of pre-mature babies who may not be able to undergo surgery to repair their hearts,” said Payal Agrawal, General Manager – Structural Heart Business, Abbott, 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,” she added.

PDA is a potentially life-threatening opening between two blood vessels leading from the heart. This channel, which is present in normally developing foetuses, is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the foetus’ 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, said the statement.

“This product is a potentially life-saving advance that will help us treat 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.”

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. Since the device is deployed in a minimally invasive procedure, many of the premature babies who are critically ill in the neo-natal intensive care unit (ICU) are able to be weaned from artificial respirator support soon after the procedure, said the statement.

“The device builds on more than 20 years of clinical success for Abbott’s family of Amplatzer Occluder therapies, including the Amplatzer Duct Occluder II product, already approved for use in the U.S., Europe and countries around the world to treat PDA in larger-size paediatric patients,” it added.