Using data supplied by Children's Hospital Boston, NMT, Inc.,  the manufacturer of the CardioSEAL and STARFlex devices, has received the first United States approval for this type of intra-cardiac occluder device.  The approval was granted for the CardioSEAL device under FDA Humanitarian Use Guidelines and is applicable to certain types of cardiac defects.

If a hospital wishes to use the CardioSEAL under Humanitarian Use Guidelines, it must receive training in the use of the device from the manufacturer.  It must also gain approval from its IRB (Institutional Review Board).