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.
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.
"Overall the NeuroBlate procedure was well-tolerated,” said lead author Andrew Sloan in prepared remarks. "All 10 patients were alert and responsive within 1 to 2 hours post-operatively and 9 out of the 10 patients were ambulatory within hours. Response and survival was also nearly 10 ½ months, better than expected for patients with such advanced disease.”
In January, Monteris Medical closed a $7.8 million funding round to support commercial efforts around the NeuroBlate system.
