Adult Congenital Heart Association
American Heart Association
Children’s Heart Foundation
www.childrensheartfoundation.org
Humanitarian Device. Authorized by Federal law (USA) for use in pediatric and adult patients with a regurgitant or stenotic Right Ventricular Outflow Tract (RVOT) conduit (≥ 16 mm in diameter when originally implanted). The effectiveness of this device for this use has not been demonstrated.
www.childrensheartfoundation.org