Press Announcements > FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

Press Announcements > FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

The U.S. Food and Drug Administration today expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved 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.Continue reading...