Acute animal studies of the STARFlex system: A new self-centering CardioSEAL septal occluder

The STARFlex system is a modified CardioSEAL device with a flexible self-ce ntering mechanism comprised of nitinol springs strung between opposing arms , a connecting ball (sleeve joint that allows the device to pivot prereleas e), and a front-loading delivery system. It was designed to allow a smaller device/defect sizing ratio and delivery profile, provide centering capabil ity, and improve closure rates. To test this system, 13 devices (23, 28, an d 33 mm) were deployed in six sheep within created atrial septal defects (1 2- to 22-mm diameter; n = 10), in the left atrium (n = 2), and in inferior vena cava (n = 1), All implantations in atrial septal defects were successf ul, with device/defect ratio ranging from 1.3 to 1.9 (median, 1.3), with no residual leak by angiography or echocardiography in seven (3/10 had less t han or equal to small immediate leaks). The STARFlex system was effective i n closing created atrial septal defects using a 10 Fr delivery sheath and l ow device/defect sizing ratios, comparing favorably with the standard Cardi oSEAL. (C) 2000 Wiley- Liss, Inc.