FDA Expands Approval of Master Series Mechanical Heart Valve to Pediatrics

The expanded approval of the heart valve makes it the smallest mechanical heart valve approved in the world, a size small enough to be used in newborn pediatric patients to treat heart defects.

The US Food and Drug Administration (FDA) expanded the approval of the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world — a size small enough to be used in newborn pediatric patients in order to treat heart defects.

Prior to today’s approval, there have been limited replacement heart valve options available for pediatric patients because of the small size, and now the Masters Series 15-mm HP valve represents an important treatment option for these patients.

“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,” Jeff Shuren, MD, JD, director, FDA’s Center for Devices and Radiological Health, said in a statement.

The Master Series Mechanical Heart Valve, manufactured by Abbott, is a rotatable, bileaflet (2-leaflet) valve, that is designed for implantation in the aortic or mitral position. The design consists of 2 semi-circular discs that open and close, responding to blood pressure changes during the heartbeat.

The approval is based on clinical data from a single-arm study of 20 pediatric patients with serious heart failure ranging in age from 1.5 weeks to 27 months at the time of mitral valve implant.

Study findings concluded that after 1 year after the implant procedure, the probability of survival was 69.3% and the probability of not experiencing a valve-related adverse effect was 66.8%.

Serious adverse effects observed during the study and follow-up included blood clots in the device and bleeding in the brain.

Anticoagulation therapy may be necessary after the procedure in order to prevent clotting on the device.

The FDA advises for the heart valve to not be used by patients unable to tolerate anticoagulation therapy.

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