A retrospective analysis of data from three medical centers has revealed promising results for the SOFIA catheter in treating acute ischemic stroke, demonstrating high success rates in both accessing and removing blood clots during endovascular procedures.
The study, conducted between November 2013 and December 2014, evaluated 115 acute stroke procedures using the SOFIA catheter, a new distal intermediate and aspiration catheter designed for stroke intervention. The results showed remarkable accessibility, with physicians successfully advancing the catheter to the occlusion site in 110 out of 115 cases (96%).
Clinical Outcomes and Safety Profile
The investigation demonstrated strong efficacy metrics, with successful recanalization achieved in 86.9% of cases, as measured by Thrombolysis In Cerebral Infarction (TICI) scores of 2b or higher. Patient outcomes showed marked improvement, with mean NIH Stroke Scale (NIHSS) scores decreasing from 16.8 (±6) at admission to 8.2 (±7.7) at discharge, indicating significant neurological recovery.
Safety data was particularly encouraging, with no complications reported during catheter positioning. Only three patients (2.6%) experienced distal thrombus migration into new vascular territory following stent retriever thrombectomy, representing a relatively low complication rate for this type of procedure.
Patient Population and Mortality
The study population consisted of acute stroke patients requiring endovascular intervention, with varying degrees of stroke severity as indicated by the initial NIHSS scores. Of the total cohort, sixteen patients died during the study period, though the specific causes of mortality were not detailed in the findings.
Technical Performance
The SOFIA catheter's high success rate in reaching target vessels suggests it may offer advantages in navigating complex cerebral vasculature. The device's performance in achieving successful recanalization compares favorably with existing treatment options, though direct comparative studies would be needed to establish superiority.
The findings suggest that the SOFIA catheter represents a promising addition to the neurointerventional toolkit for acute stroke treatment, offering a combination of reliable access, effective recanalization, and a favorable safety profile. These results may have significant implications for improving stroke care protocols and patient outcomes in the future.
