The ClearPoint Prism Neuro Laser Therapy System is authorised for use to necrotise or coagulate soft tissue using interstitial irradiation or heat therapy
ClearPoint Neuro said that its Swedish partner Clinical Laserthermia Systems (CLS) has secured the US Food and Drug Administration (FDA) 510(k) clearance for its neuro laser therapy system.
According to ClearPoint Neuro, the system will be commercialised under the name ClearPoint Prism.
The ClearPoint Prism Neuro Laser Therapy System is authorised for necrotising or coagulating soft tissue using interstitial irradiation or heat therapy under 3.0T magnetic resonance imaging (MRI) guidance.
ClearPoint Neuro has the global exclusive rights to market the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system designed for neuro applications.
The device is made up of the ClearPoint navigation platform, CLS laser technology, and Thermoguide, a thermal ablation monitoring software from France-based Image Guided Therapy.
ClearPoint Neuro said that Tthe ClearPoint Prism Neuro Laser Therapy System is presently in limited market release at certain academic medical centres in the US.
ClearPoint Neuro president and CEO Joe Burnett said: “Over the past decade, the ClearPoint Neuro Navigation System has offered an efficient one-room solution to assist neurosurgeons in the United States and Europe to accurately place laser fibers and help treat brain tumors, radiation necrosis and epileptic foci in thousands of patients.
“We look forward to leading the expansion of laser therapy treatment options for patients and neurosurgeons in the United States and beyond in the coming years.”
Last month, the firm secured FDA 510(k) clearance for its ClearPoint Maestro brain model for automatic labelling, visualisation, volumetric and shape quantification of segmentable structures of the brain. The Maestro brain model is designed to automatically detect, categorise, and measure the volume and form of the different regions of the brain that could be seen in MRI scans.