The Food and Drug Administration (FDA) has approved a new size of the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff for use in newborn pediatric patients with heart defects. The new 15mm valve size marks the smallest mechanical heart valve to be approved. 

Over 35,000 babies in the United States are born each year with congenital heart defects; some will require heart valve surgery and possible replacement heart valve surgery. Prior to the FDA’s expanded approval, there has been a lack of replacement heart valve options due to the patients’ small size. 

Findings from a single-arm study (N=20) of pediatric patients with serious heart failure (aged 1.5 weeks to 27 months) at the time of mitral valve implant were reviewed by the Agency. Study data showed a 69.3% probability of survival post-implant and a 66.8% probability of not experiencing a valve-related adverse event. Blood clots in the device and bleeding in the brain were serious valve-related events seen through 1-year follow-up. 

Abbott’s Master Series Mechanical Heart Valve was initially approved in 1995 for use in patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. It is also approved for use in patients requiring replacement aortic or mitral prosthetic heart valves. 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. 

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The Master Series Mechanical Heart Valve should not be used by patients unable to tolerate anticoagulation therapy.

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