Global healthcare company Abbott (NYSE:ABT) announced on Thursday that it has received US Food and Drug Administration (FDA) approval and CE Mark for its Amplatzer Piccolo Delivery System, which is used with its Amplatzer Piccolo Occluder.
The new delivery system is designed specifically for the treatment of premature babies (some weighing as little as two pounds) with a hole in the heart known as a patent ductus arteriosus (PDA). It is claimed to be the world's first and only minimally invasive, transcatheter treatment approved to close a PDA in premature infants with this common congenital heart defect.
Evan Zahn, MD, professor of cardiology and paediatrics and director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center in Los Angeles, California, said: "Abbott's new Amplatzer Piccolo Delivery System is a transformative step forward in how we treat PDA in premature infants. The new delivery system simplifies the implant procedure because only one catheter is needed instead of multiple, and a shorter and softer design allows for more precise device positioning in these tiny babies. Doctors can treat this group with more confidence, reducing the risk of adverse events and improving the long-term outlook for this uniquely vulnerable patient population."
Saluda Medical secures CE certification for EVA Sensing Technology in Europe
Antin to acquire clinical trial equipment provider Emsere
Hyphens Pharma licenses Cerapro skin cream to Louis Widmer for six European markets
Profusa signs French distributor to expand Lumee Oxygen rollout in Europe
Sensiva Health names new chief operating officer
BrioHealth Solutions enrols 100th participant in BrioVAD System trial
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
BioCryst wins FDA approval for oral HAE prophylaxis in young children
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
Clinical Laserthermia Systems applies for CE marking of ClearPoint Prism neuro laser system