History of The Devices

CardioSEAL & STARFlex Logo

HISTORY OF THE DEVICES

ClamShell I: Prior to the development of the device now in use, there was a device known as the ClamShell Septal Umbrella (Clamshell-I) manufactured by C.R. Bard, Inc. ClamShell-I was used in more than 900 patients during FDA trials to close both atrial septal defects (ASDs) and several other types of heart defects. During the clinical trials, it was discovered that sometimes one or more of the arms of the device broke after the device was implanted. The arms of the device are necessary to hold the device in position until tissue grows over the device. Most of the arm fractures were discovered on routine chest x-rays. Although the vast majority of patients who had devices with broken arms had no problems, concern about the arm breaks resulted in clinical trials with the ClamShell I being terminated.

DEVICE IMPROVEMENTS:

CardioSEAL: The CardioSEAL device is a redesigned version of ClamShell I. The structure of the device has changed and the material used in the device is different. The new design is currently being tested in clinical trials. For some heart defects, the CardioSEAL device has been approved for use outside of clinical trials. This approval is limited to Humanitarian Use Guidelines. Although fractures have occurred with the new device, the rate appears to be substantially lower than with the ClamShell I.

STARFlex: The STARFlex device is an updated version of the CardioSEAL device. It is structurally the same as the CardioSEAL device, with the addition of a self-centering mechanism. Although it is still unknown if the design changes in the STARFlex device will reduce the number of device arm fractures, this design should allow for more complete closure of the defect. The STARFlex device is currently being used in both the ASD Trial (where it is used exclusively) and the High Risk Trial (where the implanting doctor will decide which device is better for the defect).