FDA Approves Replacement Heart Valve For Newborn Patients

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

The Master Series Mechanical Heart Valve is a rotatable, bi-leaflet valve designed for implantation in the aortic or mitral position. The design consists of two semi-circular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve.

Each year, more than 35,000 infants in the U.S. are born with congenital heart defects, some of which will require heart valve surgery. Prior to this approval, the small size necessary for this type of treatment limited the number of available replacement heart valve options. The Masters Series 15-mm HP valve represents an important treatment option for this patient population.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and CHD and Pediatrics, Congenital Heart Disease, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, Interventions and Structural Heart Disease

Keywords: Infant, Infant, Newborn, United States Food and Drug Administration, Blood Pressure, Heart Defects, Congenital, Cardiac Surgical Procedures, Hemodynamics, Aorta, Heart Valves

< Back to Listings