The US Food and Drug Administration (FDA) has approved the first heart valve that can be implanted via a venous catheter, offering a new option for some adult and pediatric patients with congenital heart problems.
The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System was approved under the FDA's Humanitarian Device Exemption program, which allows the agency to approve a device for limited use in patients with conditions that affect fewer than 4000 US individuals each year. Products approved under the program can be used only at medical institutions that have an institutional review board to provide oversight.
De Alba F. Percutaneous Heart Valve. JAMA. 2010;303(12):1139. doi:10.1001/jama.2010.302