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THE DEVICES

 

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.