The ClearPoint Prism™ Neuro Laser Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery for a wavelength of 1064nm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the ClearPoint Prism™ Neuro Laser Therapy System can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
The ClearPoint Prism™ Neuro Laser Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of the thermal therapy. Patient management decisions should not be made solely on the basis of the analysis using the ClearPoint Prism™ Neuro Laser Therapy System.
