Michael Barbella, Managing Editor10.21.22
ClearPoint Neuro Inc.'s Swedish partner, Clinical Laserthermia Systems (CLS), has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its laser, which the company plans to commercialize as the ClearPoint Prism Neuro Laser Therapy System.
The ClearPoint Prism Neuro Laser Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0T magnetic resonance imaging (MRI) guidance.
“It’s wonderful to see new innovation in the space of laser interstitial thermal therapy. Laser ablation is an important and growing part of our surgical armamentarium and offers minimally invasive and powerful treatments for a variety of neurological diseases,” stated John Rolston, M.D., Ph.D., director of the Mapping and Engineering Neural Dynamics (MEND) Laboratory at Brigham & Women’s Hospital and Harvard Medical School. “The new laser system offered by ClearPoint has several exciting technical innovations that are expected to make this therapy simpler and more accessible to surgeons and their patients.”
ClearPoint Neuro has exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system for neuro applications. The system comprises a clinical solution combining the ClearPoint navigation platform, the laser technology from CLS, and a thermal ablation monitoring software called Thermoguide from France-based medical device company Image Guided Therapy SA (IGT).
“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,” ClearPoint Neuro President/CEO Joe Burnett said. “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. This is another example of the innovation that ClearPoint is delivering to the neurosurgery and spine community through our team and our expert partners.”
The ClearPoint Prism Neuro Laser Therapy System is currently in limited market release at select academic medical centers across the United States.
ClearPoint Neuro develops enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in more than 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with more than 45 pharmaceutical and biotech companies, academic institutions, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 5,000 cases have been performed and supported by the company’s field-based clinical specialist team, which offers support and services to customers and partners worldwide.
The ClearPoint Prism Neuro Laser Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0T magnetic resonance imaging (MRI) guidance.
“It’s wonderful to see new innovation in the space of laser interstitial thermal therapy. Laser ablation is an important and growing part of our surgical armamentarium and offers minimally invasive and powerful treatments for a variety of neurological diseases,” stated John Rolston, M.D., Ph.D., director of the Mapping and Engineering Neural Dynamics (MEND) Laboratory at Brigham & Women’s Hospital and Harvard Medical School. “The new laser system offered by ClearPoint has several exciting technical innovations that are expected to make this therapy simpler and more accessible to surgeons and their patients.”
ClearPoint Neuro has exclusive global rights to commercialize the CLS magnetic resonance (MR) guided laser interstitial thermal therapy (MRgLITT) system for neuro applications. The system comprises a clinical solution combining the ClearPoint navigation platform, the laser technology from CLS, and a thermal ablation monitoring software called Thermoguide from France-based medical device company Image Guided Therapy SA (IGT).
“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,” ClearPoint Neuro President/CEO Joe Burnett said. “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. This is another example of the innovation that ClearPoint is delivering to the neurosurgery and spine community through our team and our expert partners.”
The ClearPoint Prism Neuro Laser Therapy System is currently in limited market release at select academic medical centers across the United States.
ClearPoint Neuro develops enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the company’s current product portfolio include deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in more than 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with more than 45 pharmaceutical and biotech companies, academic institutions, and contract research organizations providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, more than 5,000 cases have been performed and supported by the company’s field-based clinical specialist team, which offers support and services to customers and partners worldwide.