FDA Clears NeuroBlate MRI-Guided Brain Tumour Ablation System

In short

Monteris® Medical has announced that the U.S. FDA has issued a second 510(k) clearance for its MRI-guided ablation device for brain tumors and other lesions.

Background

Device company Monteris® Medical is dedicated to the development of innovative MRI-guided, laser-based brain lesion therapies. The company’s NeuroBlate® System, a neurosurgical ablation device providing controlled therapy for difficult-to-treat brain tumors and epilepsy.

The NeuroBlate® System is a second generation device employing a surgical laser to ablate diseased brain tissue with updated visualization provided by active MRI. A first generation system has been available in US hospitals since 2010.

The system is indicated for use to ablate, necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. It is intended for planning and monitoring thermal therapies under MRI visualization, provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible NeuroBlate Laser Delivery Probe. It also provides real-time thermographic analysis of selected MRI images.

When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy.

Monteris also offers the AXiiiS® Stereotactic Miniframe; a single use platform for image-guided, stereotactic brain biopsy; and the AtamA™ Head Coil and Stabilization System for MRI-guided neurosurgical procedures requiring head fixation.

Physician comments

Dr. Gene Barnett, MD, MBA, Burkhardt Chair in Neurosurgical Oncology, Cleveland Clinic Neurological and Cancer Institutes offered, “The NeuroBlate System will make laser ablation of brain lesions accessible to more neurosurgeons by virtue of its intuitive user interface and time-saving enhancements. Cleveland Clinic will soon be employing this tool to treat brain tumor patients who are seeking a minimally invasive option or are not candidates for traditional surgery.”

Company comments

“Monteris invested significant resources to develop a laser ablation system that is faster and adapts to contemporary clinical workflow,” said John Schellhorn, President and CEO. “The NeuroBlate System provides neurosurgeons controlled, 3-dimensional ablation via a powerful software platform. It supports surgical decision making during brain operations as well as providing post-procedure confirmation of the effects of the thermal therapy. We believe the NeuroBlate System will offer a new option for surgeons managing patients with brain tumors and other neurologic lesions.”

Source: Monteris Medical, Inc., Business Wire

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