chapter  26
7 Pages

Complications of the CardioSEAL Occluder (NMT Medical)

WithMark Reisman

In Europe, CardioSEAL was awarded the CE mark in September 1997 and is now commercially available.The CE mark signifies that the product has been designed, tested, and manufactured in a manner which demonstrates safe use in humans. In the US, the CardioSEAL device is only approved for ventricular septal defects, but is used in an off-label fashion for patent foramen ovale.