Monteris wins U.S. and Canadian nods for its NeuroBlate tumor "cooker"

April 15, 2013 by Sony Salzman

Monteris Mecical scores regulatory wins in the U.S. and in Canada, also touting positive clinical trial results for the NeuroBlate MRI-guided brain tumor treatment system.

Monteris Medical logo

Monteris Medical won a regulatory nod in the U.S. and in Canada for its NeuroBlate MRI-guided tumor ablation device, the company said.

Monteris calls NeuroBlate a tumor "cooker" which uses an MRI-guided laser system to heat and kill brain tumors. Positive results in the 1st-in-human trials were published earlier this month in the Journal of Neurosurgery.

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The device, which was developed in partnership with Case Comprehensive Cancer Center, won the FDA's 510(k) clearance and regulatory approval from Health Canada, according to company announcements. The Plymouth, Minn.-based device maker said that this marks the 1st approval of the device in Canada and the 2nd clearance in the U.S. The 1st-generation NeuroBlate system has been available in the States since 2010.

Prior clinical trials conducted at Cleveland Clinic and University Hospitals Case Medical Center evaluated the device on inoperable tumors in 10 high-risk patients.