LAUSR

BACKGROUND The ClearPoint SmartFrame Array® system consists of a magnetic resonance imaging (MRI) compatible frame supported by a customized neuro navigation software. This system received Food and Drug Administration (FDA) clearance for clinical use in January 2021. OBJECTIVE To report initial safety data and user experience of SmartFrame Array®-supported stereotactic procedures. METHODS We prospectively followed the first ten, consecutive patients who underwent stereotactic procedures supported by SmartFrame Array®. Clinical and procedural data were recorded and compared to data obtained from prior cases with SmartFrame XG®. RESULTS Ten patients underwent stereotactic needle biopsy, stereotactic laser ablation (SLA), or combined biopsy/SLA procedures. For needle biopsies (n=9), the average maximal diameter of the contrast-enhancing target lesion was 9.9 + 2.8 mm. The radial error of stereotaxis was less than 2 mm. Definitive diagnosis was achieved in all cases. For procedures involving SLA (n=5), 100% of the contrast-enhancing lesion was ablated. All patients were discharged home by postoperative day two. There were no 30-day readmissions, morbidity, or mortality. The average stereotaxis time for the SmartFrame Array®-aided single trajectory procedure was 80 + 9.5 minutes, which compared favorably to that required for the earlier generation SmartFrame XG® frame (111.5 ± 16.5 minutes; p < 0.01). The unique Array design supported stereotactic procedures that cannot be easily achieved with the previous SmartFrame XG® frame. CONCLUSION The SmartFrame Array® system offers a more rigid and compact build to enhance procedural efficiency while maintaining accuracy and safety. The design supports multi-trajectory stereotaxis, allowing novel clinical applications.