Sam Brusco, Associate Editor01.17.24
ClearPoint Neuro has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its SmartFram OR stereotactic system.
The system is comprised of the SmartFrame OR and ClearPointer optical navigation wand. SmartFrame OR provides stereotactic guidance for placing instruments or devices during neurological procedure planning and operation, performed in tandem with a compatible, optical stereotactic navigation system using pre-op MRI and/or CT images. Procedures include biopsies, catheter placement, and electrode introduction.
ClearPointer is used with SmartFram OR and compatible stereotactic optical navigation for patient registration and navigation. SmartFrame OR can also be used with or without bone screw fiducials.
The company plans to begin limited market launch in H1 2024, with planned full release in H2.
“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” said ClearPoint Neuro CEO Joe Burnett. “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.”
The system is comprised of the SmartFrame OR and ClearPointer optical navigation wand. SmartFrame OR provides stereotactic guidance for placing instruments or devices during neurological procedure planning and operation, performed in tandem with a compatible, optical stereotactic navigation system using pre-op MRI and/or CT images. Procedures include biopsies, catheter placement, and electrode introduction.
ClearPointer is used with SmartFram OR and compatible stereotactic optical navigation for patient registration and navigation. SmartFrame OR can also be used with or without bone screw fiducials.
The company plans to begin limited market launch in H1 2024, with planned full release in H2.
“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” said ClearPoint Neuro CEO Joe Burnett. “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.”