Plymouth's Monteris Medical has obtained a new-product clearance from the Food and Drug Administration that should permanently resolve an issue with older versions of the NeuroBlate system, which uses laser energy to burn away irregularly shaped brain cancers.
Monteris announced Tuesday that it has received FDA permission to market a component called the NeuroBlate Optic Laser Probe, which is the component of the NeuroBlate system that is inserted into a small hole in the patient's skull to precisely deliver energy to treat lesions including cancers.
The new laser probe has fiber-optic controlled cooling, and it doesn't contain a metal thermocouple that could heat up while using the magnetic resonance imaging-guided device.
A Class I recall notice that went out to hospitals last fall, and was published by the FDA in March, said there was a risk that the older probes could be damaged by overheating that happened during use with an MRI scanner, and a damaged probe could lead to unintended tissue damage. The newly cleared probe doesn't have that risk.
"Because all patient-contacting components of the NeuroBlate Optic Laser Probe are nonmetallic, MR scan restrictions issued as part of the field advisory notice in the fall of 2017 are eliminated," the announcement from Monteris said. "Due to its nonmetallic fiber-optic temperature sensor, the NeuroBlate Optical Laser Probe allows for more freedom to customize the trajectory during surgical planning and positioning."
The NeuroBlate system, which received 501(k) clearance from the FDA in 2013, has been used in more than 2,000 procedures at the 60 locations in the U.S. and Canada where it has been installed to date.
The system is described as a minimally invasive, robotically controlled "thermography" that uses MRI-guided laser light to heat up and destroy unwanted tissue in the brain, including cancerous lesions and epileptic foci. The system requires a skull incision about the diameter of a pencil, rather than the larger incisions required for traditional surgical approaches.
While the patient is in the MRI machine, the doctor inserts the laser probe into the small hole and delivers 1,064-nanometer laser energy. Using that wavelength allows for slower and more controlled heating of targeted ablation zones, which can be precisely visualized on the MRI.
"The Optic Laser Probe's fiber optic temperature sensor retains the NeuroBlate System's unique ability to deliver ablation and cooling control while also raising the probe's safety profile," Monteris CEO Marty Emerson said in the announcement of the FDA clearance. "This is an important milestone for Monteris Medical, as well as the neurosurgeons and patients we serve."
Joe Carlson • 612-673-4779
