The valve, which is claimed to be the world's smallest mechanical heart valve. will help doctors to replace mitral or aortic valve in babies and toddlers.
Abbott’s dime-sized new valve is said to be the first and only pediatric mechanical heart valve developed for newborns and infants.
Surgeons generally use a range of larger-sized valves to replace a pediatric heart valve, which cannot be repaired easily.
To provide the body with oxygen-rich blood, the heart's mitral and aortic valves move blood across the heart.
When functioning correctly, both valves open and close sequentially as blood enters and leaves the heart with each contraction. Heart failure is expected to occur when either valve doesn't work properly.
The approval was based on the data of a clinical trial that recruited pediatric patients five years of age or younger who had a diseased, damaged or malfunctioning heart valve.
The Masters HP 15mm, which is a rotatable and bileaflet mechanical heart valve, is part of the Masters Series line that comprises seven valves with diameter sizes ranging from 15mm to 27mm
First approved in 1995, the valves are provided with pyrolytic carbon leaflets and orifice rings, as well as 85-degree leaflet opening angle to improve flow and reduce turbulence and controlled torque rotation mechanism for rotation and intraoperative adjustment.
A sewing cuff includes additional suture markers for accurate placement.
Abbott's structural heart business vice president Michael Dale said: "There's an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive.
"Abbott's new mechanical pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart."
Image: FDA has approved Abbott’s Masters HP 15mm rotatable mechanical heart valve to treat pediatric patients. Photo: courtesy of Abbott.
