FDA CLEARS WORLD'S SMALLEST MECHANICAL HEART VALVE

The Medscape - The US Food and Drug Administration (FDA) expanded approval of the Masters Series Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Abbott) to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.Until now, pediatric patients have had limited replacement heart valve options because of their small size. 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...>>>