Abbott's Masters HP 15-mm Pediatric Heart Valve Approved by FDA

March 8, 2018–Abbott announced that the US Food and Drug Administration (FDA) approved its Masters HP 15-mm rotatable mechanical heart valve, which will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement.

As noted by the company, surgeons have had only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of children's hearts. This dime-sized new valve is specifically designed as a pediatric mechanical heart valve for newborns and infants with congenital heart defects.

The Masters HP 15-mm device is a rotatable, bileaflet mechanical heart valve designed for implantation in the mitral or aortic position and is part of the Abbott's Masters Series portfolio, which now includes seven valves with diameter sizes ranging from 15 to 27 mm.

The approval of Abbott's Masters HP 15-mm rotatable mechanical heart valve was primarily based on the results of a clinical trial that enrolled pediatric patients who are 5 years old or younger and had a diseased, damaged, or malfunctioning heart valve.

In the company's announcement, study investigator Kirk R. Kanter, MD, commented, "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 pediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children."