Easing Neurosurgery With Newly Approved SmartFrame OR Stereotactic System: Joe Burnett

WATCH TIME: 3 minutes

"This should be the easiest product for us to bring into a lab because it doesn’t require any of our own hardware or software or capital equipment to come in. It’s compatible with a device or series of devices that are already very commonplace in the operating room today."

The field of neurosurgery has consistently represented an area of innovation and integrating of technology since its inception. Several neurological procedures necessitate a substantial amount of pre-, post-, and intraoperative clinical data acquisition, making decisions, attention, and convalescence.

Earlier this month, the FDA granted 510(k) clearance to ClearPoint Neuro for its SmartFrame OR Stereotactic System, a device intended to guide the placement and operation of instruments or devices during planning and operation of neurological procedures. Comprised of the SmartFrame OR and the ClearPointer Optical Navigation Wand, the system is geared towards those set to undergo biopsies, catheter placement, or electrode introduction. The company is planning to commence limited market release in the first half of 2024, with a planned full market release in the second half of the year.

At the core of ClearPoint’s navigation system is an MRI-compatible stereotactic frame that is mounted on the patient’s skull; subsequent MRIs taken with this mounted frame are processed by an integrated software to define and align to the optimal stereotactic trajectory. The newly approved stereotactic system is the first product in ClearPoint’s history that does not require the use of MRI during the procedure, allowing for greater access to more hospitals.

To learn more about how the recent approval impacts the workflow of operating rooms and neurosurgery, NeurologyLive® sat down with Joe Burnett, chief executive officer at ClearPoint. In the interview, Burnett spoke on the novelty of the device and how it can be easily integrated into clinical care settings, as well as the significance of not needing an MRI while performing a neurosurgical procedure.

REFERENCE
1. ClearPoint Neuro announces FDA clearance for SmartFrame OR Stereotactic System. News release. January 16, 2024. Accessed January 25, 2024. https://ir.clearpointneuro.com/news-events/press-releases/detail/1098/clearpoint-neuro-announces-fda-clearance-for-smartframe