Abbott Reports FDA Clearance and CE Mark Approval of its Amplatzer Piccolo Delivery System for Premature Babies with a Hole in the Heart
Shots:
- Abbott has received the US FDA clearance & European CE Mark for its Amplatzer Piccolo Delivery System, used with Amplatzer Piccolo Occluder, to treat premature babies (≥2lbs) with patent ductus arteriosus (PDA; hole in the heart)
- Approved in the US & EU in 2019, Amplatzer Piccolo Occluder is a minimally invasive transcatheter device, smaller than a pea, to close PDA in premature infants, which is now equipped with a delivery system
- Amplatzer Piccolo is delivered via a small leg incision & guided to the heart using a single, shorter & softer catheter, simplifying implantation & enabling more precise placement in premature infants
Ref: Abbott | Image: Abbott | Press Release
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