FDA Clears Stereotactic System for Neurologic Surgeries and Procedures
The Food and Drug Administration (FDA) has granted 510(k) clearance to the SmartFrame OR Stereotactic System (ClearPoint Neuro, Solana Beach, CA), which consists of the SmartFrame OR, a system that assists in the placement of instruments or devices during neurologic, stereotactic surgeries and procedures, and the ClearPointer Optical Navigation Wand. According to a statement from the company, ClearPoint Neuro expects to release the SmartFrame OR Stereotactic System on a limited-market basis in the first half of 2024 and on a full-market basis in the second half of the year.
The approved platform’s SmartFrame OR component is intended to be used in combination with a compatible optical stereotaxic navigation system that utilizes preoperative CT and/or MR imaging, while the ClearPointer Optical Navigation Wand component functions in conjunction with a compatible optical stereotactic navigation system to assist in patient navigation and registration. The SmartFrame OR Stereotactic System is designed to assist in placing catheters, introducing electrodes, conducting biopsies, and other procedures. According to ClearPoint Neuro, the SmartFrame OR Stereotactic System constitutes an improvement over other stereotactic neuronavigation platforms because imaging takes place before and not during surgery.
“More than 95% of all stereotactic neuro-navigation procedures take place in the OR, supporting DBS, Laser Ablation, Biopsy, sEEG, and more,” said Joe Burnett, President and CEO of ClearPoint Neuro. “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.”