ClearPoint system is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint system is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion.
The ClearPoint® system is the only surgical platform that provides real-time MRI guidance for a range of minimally invasive procedures in the brain. It is an integrated system of hardware components, disposable components and intuitive, menu-driven software.
ClearPoint procedures can be performed in a hospital's existing diagnostic MRI suite and can be used with both 1.5T and 3T scanners.
The ClearPoint reusable hardware includes a integrated head fixation frame, dedicated computer workstation, and MRI-compatible in-room computer monitor.
The ClearPoint SmartFrame® device is a single-use, disposable trajectory frame that is MRI-compatible and enables the MRI-guided alignment and insertion of devices used during ClearPoint procedures. The trajectory of the SmartFrame device can be adjusted from outside the bore of the MRI scanner with a disposable physician controller.
The ClearPoint software is an intuitive, menu-driven software system used to guide the physician in all aspects of a ClearPoint procedure, including surgical planning, device alignment, navigation to target, procedure monitoring and report generation at the conclusion of the ClearPoint procedure.
The ClearPoint surgical kit includes all accessory components necessary for a ClearPoint procedure. These components include a surgical draping, which helps create a sterile surgical field in a standard diagnostic MRI suite, and the SmartGrid® array, which assists the surgeon in identifying the entry point for a ClearPoint procedure.
The ClearPoint real-time interventional MRI-guided methodology for deep brain stimulation (DBS) lead placement may offer advantages to frame-based approaches and allow accurate implantation under general anesthesia. In a study, Ostrem et al assessed the safety and efficacy of DBS in Parkinson's disease (PD) using this surgical method.
Symptom severity was evaluated at baseline and 12 months postimplantation using the change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III “off” medication score as the primary outcome variable.
Twenty-six PD patients (15 men and 11 women) were enrolled from 2010 to 2013. Twenty patients were followed for 12 months (16 with a subthalamic nucleus target and 4 with an internal globus pallidus target). The mean UPDRS Part III “off” medication score improved from 40.75 ± 10.9 to 24.35 ± 8.8 (p = 0.001). “On” medication time without troublesome dyskinesia increased 5.2 ± 2.6 hours per day (p = 0.0002). UPDRS Parts II and IV, total UPDRS score, and dyskinesia rating scale “on” medication scores also significantly improved (p < 0.01). The mean levodopa equivalent daily dose decreased from 1072.5 ± 392 mg to 828.25 ± 492 mg (p = 0.046). No significant cognitive or mood declines were observed. A single brain penetration was used for placement of all leads, and the mean targeting error was 0.6 ± 0.3 mm. There were 3 serious adverse events (1 DBS hardware-related infection, 1 lead fracture, and 1 unrelated death).
DBS leads placed using the ClearPoint interventional real-time MRI-guided method resulted in highly accurate lead placement and outcomes comparable to those seen with frame-based approaches 1).