The CardioSEAL device is a small double umbrella with two
sets of tiny metal arms attached to Dacron fabric and is manufactured by
Nitinol Medical Technologies, Inc.
It was designed to close holes in the Atrial Septum (known as ASDs),
but is used to close other types of holes as well. The device is
folded into a special catheter, inserted in a vein, moved into the heart and
through the hole. The device is slowly pushed out of the delivery
catheter, allowing each umbrella to open up and cover each side of the hole
and close it. When the device is in proper position, it is
released. The delivery catheter is then removed. The device
remains in the heart and serves to close the hole.
The STARFlex device is an updated version of the CardioSEAL
device. A self-centering mechanism has been built into the device consisting
of four flexible springs which pass between the two fabric disks. This
updated design should improve the ability of the device to center itself into
the defect. The STARFlex device is delivered to the defect in the same manner
as the CardioSEAL. The delivery catheter has been updated to allow for an
easier delivery and positioning of the device.