St. Jude Medical has launched a clinical study of its Masters HP Series 15 mm mechanical heart valve, the world’s smallest pediatric heart valve. The HALO trial will evaluate the valve’s safety and efficacy in pediatric patients who need of mitral valve replacement, cannot be implanted with approved valves without added risk and have no other treatment options.
There are few artificial heart valves available for children under age five, forcing surgeons to sometimes implant larger ones in these small patients, the St. Paul, Minn., devicemaker said. This can lead to suboptimal placement, which can damage surrounding tissue and cause other complications.
The 15 mm valve stems from an FDA-led workshop in 2010 on the pressing need to develop products for the pediatric population, St. Jude said. The agency suggested making smaller versions of approved adult valves, since those would provide a reasonable assurance of safety and effectiveness.
The trial will enroll patients at up to 40 sites nationwide. St. Jude will use the data it collects to support FDA approval of the Masters Series 15 mm valve. The valve is currently available for emergency or compassionate use.
More than 35,000 babies are born with congenital heart defects each year in the U.S., some of whom will require valve replacement, according to St. Jude. The smallest approved valves for use in newborns, infants and toddlers are 16 mm.