Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world.
The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or mitral position and consists of two semi-circular discs that open and close in response to blood pressure changes during the heart beat, according to an FDA release.
The newly approved 15mm version of the device clears the valve for use in pediatric patients who previously had no options, the FDA said.
The agency claims that more than 35,000 babies are born in the US each year with congenital heart defects, many of which will require replacement heart valves that, prior to the approval, were not available.
“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” FDA Center for Devices and Radiological Health director Dr. Jeff Shuren said in a press release.
Approval came based off clinical data from a single-arm study of 20 pediatric patients, between the ages of 1.5 weeks and 27 months, with serious heart failure in which the device was used as a mitral valve replacement.
Data from the study showed that one year post-implant, survival rates were 69.3% while the rate of freedom from valve-related adverse events was 66.8%, according to the FDA release.
Serious adverse valve-related events noted during the study include blood clots in the device and brain bleeds. The FDA said that anticoagulation therapy may be required to help prevent device clotting.