Abbott has received the European CE-Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo Occluder device to treat babies and children with common congenital heart defects (CHD).
The devices are meant to treat paediatric patients when no other suitable therapies are available.
The rotatable, bileaflet 15mm Masters HP is designed for mitral or aortic valve replacement in babies and toddlers and is considered the world’s smallest mechanical heart valve.
The valve expands Abbott’s Masters Series range, which comprises seven devices ranging from 15mm to 27mm in diameter.
A mechanical valve is required to restore function in the event of significant malformation in the heart valve tissues, which causes irreparable damage.
The heart valve works similarly to a healthy heart valve, opening and closing with each heartbeat and allowing adequate blood flow through the organ.
The minimally invasive Amplatzer Piccolo device is said to be the first that can be implanted even in the smallest babies for the treatment of patent ductus arteriosus (PDA), a fatal opening in the heart.
It is a self-expanding, wire mesh device that can be inserted via a small incision in the leg and guided through vessels to the heart to close the PDA opening.
The device is for use as a corrective treatment in premature infants and newborns who may not respond to medical management and are at high risk for corrective surgery.
Abbott structural heart business vice-president Michael Dale said: “While the children who benefit from these therapies represent a very small segment of the total population with structural heart disease, these advanced technologies enable physicians to treat vulnerable paediatric patients who otherwise have limited options.”
Each year, congenital heart defects affect nearly 36,000 births in the EU, noted the company.