NMT Medical CardioSeal
This article was originally published in The Gray Sheet
Executive Summary
Septal occluder cardiac implant receives second FDA humanitarian use designation approval, expanding use to include closure of ventricular septal defects that cannot be closed using standard surgical approaches, the firm announces Sept. 28. On Sept. 9, NMT announced FDA approval for humanitarian use (under 4,000 patients) of the device to close fenestrated Fontan procedures (1"The Gray Sheet" Sept. 13, In Brief)