Future of MedTech Patients

WORLD’S FIRST HEART DEVICE FOR BABIES APPROVED

A world-first medical device that can be implanted in babies weighing as little as two pounds has been given the tick of approval from the U.S. Food and Drug Administration (FDA).

An invention of medical device company Abbott, the pea-sized self-expanding device, called the Amplatzer Piccolo Occluder, now offers hope to premature infants and newborns who need corrective treatment, may be non-responsive to medical management or high-risk to undergo corrective surgery.

The device 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. The minimally invasive procedure to insert the device means 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.

Born at 27 weeks, twin babies Irie and Judah Felkner of Columbus, Ohio, were both fighting for their lives in the neonatal intensive care unit when an echocardiogram revealed Irie had a patent ductus arteriosus (PDA) – a potentially life-threatening opening between two blood vessels leading from the heart – that required immediate treatment.

Irie’s mother, Crissa Felkner said “The doctor thought Abbott’s Amplatzer Piccolo device was the best solution for Irie, and after learning more about the procedure we decided to move forward”.

“You have to live it to fully appreciate what that device did for our daughter. Three days after the procedure, she was making great progress and is now a normal toddler with no limitations. The Abbott device was truly lifesaving for our daughter,” Mrs Felkner said.

Vice President of Abbott’s structural heart business, Michael Dale, said “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.”

“Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve,” Mr Dale said.

Amplatzer Piccolo Occulder is not yet available for Australian consumers.

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