Neurosurgical laser ablation device receives FDA clearance
The FDA has granted Monteris Medical with a second 510(k) clearance for the company's magnetic resonance imaging (MRI)-guided laser ablation device for brain tumors and other lesions.
The FDA has granted Monteris Medical (Minneapolis, MN) with a second 510(k) clearance for the company's magnetic resonance imaging (MRI)-guided laser ablation device for brain tumors and other lesions. Called NeuroBlate, the device employs a surgical laser to ablate diseased brain tissue with updated visualization provided by active MRI. A first-generation version of the device has been available in U.S. hospitals since 2010.
Gene Barnett, MD, MBA, Burkhardt Chair in Neurosurgical Oncology, Cleveland Clinic Neurological and Cancer Institutes, notes that Cleveland Clinic will soon be using the NeuroBlate device to treat brain tumor patients who are seeking a minimally invasive option or are not candidates for traditional surgery.
NeuroBlate enables controlled, 3D ablation via a powerful software platform, explains John Schellhorn, Monteris' president and CEO. It supports surgical decision-making during brain operations as well as provides post-procedure confirmation of the effects of the thermal therapy, he adds.
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