FDA clears Monteris MRI-guided ablation device for brain tumor treatment

9 April 2013 (Last Updated April 9th, 2013 18:30)

Monteris Medical has obtained 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its NeuroBlate system, designed for the treatment of brain tumors and other lesions.

Monteris Medical has obtained 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its NeuroBlate system, designed for the treatment of brain tumors and other lesions.

The device, a second-generation product, features a surgical laser to ablate (lethally heat) diseased brain tissue and an MRI system to guide and provide visualisation during the procedure.

Monteris Medical president and CEO John Schellhorn said the company has invested significant resources to develop a laser ablation system that is faster and adapts to contemporary clinical workflows.

"The NeuroBlate system provides neurosurgeons controlled, 3-dimensional ablation via a powerful software platform," Schellhorn said.

"The device, a second-generation product, features a surgical laser to ablate (lethally heat) diseased brain tissue and an MRI system to guide and provide visualisation during the procedure."

"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."

Neurological and Cancer Institutes Cleveland Clinic neurosurgical oncology Burkhardt chair Dr Gene Barnett said the intuitive user interface and time-saving features of the neurosurgical device also makes laser ablation of brain lesions accessible to more neurosurgeons.

"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," Barnett said.

The company also offers AXiiiS stereotactic miniframe, a single-use platform for image-guided, stereotactic brain biopsy and the Atama head coil and stabilisation system for MRI-guided neurosurgical procedures requiring head fixation.