FDA approves the world’s smallest mechanical heart valve

Masters HP 15mm

The US FDA has approved the Masters HP 15mm rotatable mechanical heart valve (Abbott), which a press release says is the world’s smallest mechanical heart valve. It adds that valve is designed to treat the babies and toddlers in need of a mitral or aortic valve replacement. This dime-sized new valve is the first and only paediatric mechanical heart valve developed for newborns and infants.

According to the press release, prior to the approval of Masters HP,  surgeons could only use a range of larger-sized valves to replace a paediatric heart valve that could not be repaired and larger valves are often not suitable given the smaller size of children’s hearts. Therefore for children who have a poorly functioning valve that cannot be repaired, a valve replacement procedure using the 15mm mechanical heart valve is now an option.

Kirk R Kanter (Emory University School of Medicine, USA), comments: “In my practice, I want to be able to provide a treatment option that works for a critically ill child when a larger-sized valve may not be suitable.  The approval of this smaller paediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children.”

The approval of Abbott’s new Masters HP 15mm rotatable mechanical heart valve was primarily based on the results of a clinical trial, which enrolled paediatric patients five years of age or younger who had a diseased, damaged or malfunctioning heart valve. Jonathan M Chen (Seattle Children’s Hospital Heart Center, Seattle, USA) was the first physician in the trial to implant the Masters HP 15mm valve in a paediatric patient.

Michael Dale, vice president of Abbott’s structural heart business, comments: “There is an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive. Abbott’s new mechanical paediatric heart valve is a life-changing technology for the smallest paediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart.”


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