ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine
ClearPoint gets FDA apprval for SmartFrame OR Stereotactic System. (Credit: Piron Guillaume on Unsplash)
ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its SmartFrame OR™ Stereotactic System.
The SmartFrame OR Stereotactic System is composed of two main components: the SmartFrame OR, and the ClearPointer™ Optical Navigation Wand. The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during 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. These procedures include biopsies, catheter placement and electrode introduction. The ClearPointer is intended to be used in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR may be used with or without available bone screw fiducials. The Company plans to commence limited market release in the first half of 2024, with a planned full market release in the second half of 2024.
“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” stated 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,” said 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.”
Source: Company Press Release