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We are proud to announce that CLS has received FDA 510(k) clearance for our MR guided laser ablation system in neurosurgery! The clearance marks a breakthrough in the field of neurosurgery and for minimally invasive treatments of brain lesions that will now be performed more efficiently and safely. The system will be commercialized by our global distributor ClearPoint Neuro Inc.
CLS’s 510(k) clearance was achieved thanks to a close collaboration with CLS’s global distributor ClearPoint Neuro who has supported CLS during the entire 510(k) application process. ClearPoint Neuro provides a global, therapy-enabling platform for navigation and delivery to the brain which together with CLS’s system provides a fully integrable system for MR-guided, stereotactic laser ablation of brain lesions.
Having secured the FDA 510(k) clearance, commercialization of the integrated system can be initiated. The integrated system will be commercialized under the brand name ClearPoint Prism™ Neuro Laser Therapy System by ClearPoint Neuro that is the exclusive global distributor of CLS’s system for the neurosurgery market segment.
One of the neurosurgeons who has high expectations for the new system is John Rolston, MD, PhD, Director of the Mapping & Engineering Neural Dynamics (MEND) Laboratory at Brigham and Women’s Hospital and Harvard Medical School. He stated:
“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. 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”.
Read the full Press Release about the FDA 510(k) clearance here.
In a previous interview Joseph M. Burnett, CEO & President at ClearPoint Neuro, talks about how the ongoing collaboration between ClearPoint Neuro and CLS will enable unique streamlined laser ablation treatments of patients with brain tumors, or drug-resistant epilepsy, and the benefits this brings for the patients. By combining the navigation system of ClearPoint Neuro with CLS´ TRANBERG® Thermal Therapy System one team of physicians will be able to perform the whole procedure inside the MRI scanner.
Watch the interview here.
The ClearPoint Prism Neuro Laser Therapy System is currently in limited market release at selected academic medical centers across the United States.
Read more about the PRISM System here.
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Please note that all our products and indications are not yet approved in all markets. Don’t hesitate to contact us for up-to-date market approvals in your area!
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