Key result
The STARFlex system was successfully deployed in 100% of created atrial septal defects in sheep, with no residual leak in 70% of cases.
Why the study?
Does the STARFlex system effectively close created atrial septal defects in a sheep model?
Does the STARFlex system effectively close created atrial septal defects in a sheep model?
The STARFlex system demonstrated acute feasibility and effectiveness in closing created atrial septal defects in a sheep model.
Answers are grounded in this paper and cite their sources.
Demonstrates acute feasibility in ovine ASD model; leaves open translation to human closure trials.
The STARFlex system is a modified CardioSEAL device with a flexible self-centering mechanism comprised of nitinol springs strung between opposing arms, a connecting ball (sleeve joint that allows the device to pivot prerelease), and a front-loading delivery system. It was designed to allow a smaller device/defect sizing ratio and delivery profile, provide centering capability, and improve closure rates. To test this system, 13 devices (23, 28, and 33 mm) were deployed in six sheep within created atrial septal defects (12- 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 successful, 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 </= small immediate leaks). The STARFlex system was effective in closing created atrial septal defects using a 10 Fr delivery sheath and low device/defect sizing ratios, comparing favorably with the standard CardioSEAL. Cathet. Cardiovasc. Intervent. 49:225-233, 2000.
No takes yet. Share an insight, caveat, or question.
Kreutzer et al. (2000) studied Atrial septal defects (n=6). STARFlex system was evaluated on Successful implantation in atrial septal defects. The STARFlex system was successfully deployed in 100% of created atrial septal defects in sheep, with no residual leak in 70% of cases.
Synapse has enriched 10 related papers. Consider them for comparative context: