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NMT Medical CardioSeal

This article was originally published in The Gray Sheet

Executive Summary

Septal occluder cardiac implant gains FDA humanitarian use designation approval for closing fenestrated Fontan procedures. Designed to close holes in the heart, the device is in clinical trials for "broader approval," NMT says. The HUD allows treatment of up to 4,000 patients per year

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NMT Medical CardioSeal

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)

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