First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation

The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. The device, developed by world-leading medical technology company Medtronic, is indicated for both pediatric and adult patients who have severe pulmonary valve regurgitation. The condition causes blood to leak backward into the right lower chamber of the heart.