Abbott has secured the US Food and Drug Administration (FDA) and CE Mark approvals for its Amplatzer Piccolo delivery system, designed for premature infants diagnosed with patent ductus arteriosus (PDA).
The approval allows for its use alongside the Amplatzer Piccolo occluder, especially tailored for infants with this congenital heart condition.
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PDA is a condition characterised by an opening between two blood vessels in a newborn’s heart that does not close after birth as it typically should.
This opening, which is necessary before birth to allow blood to bypass the lungs, can cause complications if it remains open, including abnormal blood flow to the lungs and difficulty breathing.
The Amplatzer Piccolo occluder is a minimally invasive, transcatheter device used for closing a PDA in premature infants.
The device is inserted via a small incision in the leg and navigated through the vessels to the heart using the Amplatzer Piccolo delivery system. It seals the heart opening once it is in place.
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By GlobalDataThe occluder previously secured CE Mark and FDA approval in 2019.
Abbott structural heart business senior vice-president Sandra Lesenfants said: “We designed the Amplatzer Piccolo delivery system based on feedback from leading physicians across the world to make PDA closure procedures even safer and easier.
“With the Amplatzer Piccolo occluder, which is the world’s smallest heart device, and now with the new delivery system to complement it, we’re continuing to advance how we meet the needs of our tiniest patients with structural heart disease.”
The company’s range of paediatric heart treatments also includes the Masters HP 15mm mechanical heart valve and the HeartMate 3 heart pump, which secured approval for use in paediatrics.
Last month, Abbott entered a definitive agreement to acquire all outstanding shares of Exact Sciences for an estimated enterprise value of $23bn, marking its entry into the cancer diagnostics market.
