Abbott’s latest device approval is a tiny advance
FDA approval of Abbott’s Amplatzer Piccolo means that even the smallest patients with patent ductus arteriosus now have a device to close the hole in their heart. The minute device is approved for use in premature babies, including those weighing as little as 2lb – and since open-heart surgery is of course very risky in such tiny patients the Piccolo, which is implanted via the femoral artery in a much safer minimally invasive procedure, will be hugely appealing. That said, the device is unlikely to be a huge money-spinner for Abbott since only around 12,000 babies are born each year in the US with PDA severe enough to warrant treatment. The device is the latest in the Amplatzer range of products designed to plug various kinds of holes in the heart, also including the Amplatzer Duct Occluder II, which treats PDA in larger paediatric patients, and the Amplatzer PFO Occluder, used to treat patent foramen ovale.