The US Food and Drug Administration (FDA) expanded approval of the heart valve (Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff, Abbott).
This new dime-sized 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.
The device consists of a rotatable, bileaflet valve intended for aortic or mitral position implant where its two semi-circular discs open and shut in response to blood pressure changes during the heartbeat.
The Masters Series 15-mm HP valve represents an important treatment option for these patients, the FDA said in a statement.
“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,” said Jeff Shuren, MD, director, FDA Center for Devices and Radiological Health.
Approval of the smaller size valve was based on a clinical study of 20 infants ranging in age from 1.5 weeks to 27 months.
Potential valve-related adverse reactions could include blood clots in the device and bleeding in the brain. The valve should not be used in patients who cannot tolerate anticoagulation therapy, the FDA said.
A mechanical heart valve mimics the valve of a healthy heart, opening and closing with each heartbeat, permitting proper blood flow through the heart.
“There’s an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive,” said Michael Dale, vice president of Abbott’s structural heart business.
“Abbott’s new mechanical pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart.”
The device is part of the Masters Series line, which now includes seven valves with diameter sizes ranging from 15 to 27mm.