07 March 2018 | News
FDA approves First and only pediatric mechanical heart valve for Pediatric Patients with Heart Defects
Abbott announced that U.S. Food and Drug Administration (FDA) approved the Masters HP™ 15mm rotatable mechanical heart valve, the world's smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement.
Until today, surgeons could 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 the first and only pediatric mechanical heart valve developed for newborns and infants, and offers hope for pediatric patients in urgent need of treatment who have no other approved options.