Stereotactic Navigation System Enhances Precision of Brain and Spinal Surgeries

The integration of image-guided navigation with intraoperative magnetic resonance imaging (MRI) has facilitated real-time surgical decisions to improve clinical outcomes. Now, a stereotactic system is designed to enable such integration by providing stereotactic guidance for the placement and operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging.

ClearPoint Neuro’s (Solana Beach, CA, USA) SmartFrame OR stereotactic system comprises two key components: the SmartFrame OR, and the ClearPointer Optical Navigation Wand. The SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices during the planning and operation of neurological procedures performed along with a compatible optical stereotaxic navigation system utilizing preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement, and electrode introduction. The ClearPointer is designed for use in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR can be used with or without available bone screw fiducials. The company will kick off a limited market release in the first half of 2024 and plans the full market release during the second half of 2024.

Image: The SmartFrame OR Stereotactic System has been granted FDA clearance (Photo courtesy of ClearPoint Neuro)

“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” said Joe Burnett, President and CEO at ClearPoint Neuro. “More than 95% of all stereotactic neuro-navigation procedures take place in the OR, supporting DBS, Laser Ablation, Biopsy, sEEG, and more. This product is the first in ClearPoint’s history that does not require the use of MRI during the procedure, allowing us to access more hospitals, and to support an order of magnitude more patients than our legacy portfolio. Importantly, the SmartFrame OR is compatible with capital hardware and software already present in many neurosurgical operating rooms and should not require the approval by hospital capital committees for surgeons to try this new product.”

“SmartFrame OR embodies over a decade of accumulated expertise in MRI-guided navigation, now enhanced with the latest OR imaging technology,” added Rob Rubio, Segment Leader for Neuromodulation at ClearPoint Neuro. “It offers surgeons flexible workflows, including iCT forward projection, enabling precise image-based corrections to achieve submillimetric accuracy.”