Monteris wins FDA nod for NeuroBlate Optic laser probe

Monteris Medical said today it won FDA clearance for the NeuroBlate Optic laser probe designed for its minimally invasive magnetic resonance imaging-guided NeuroBlate robotic laser thermotherapy system, which is intended for use in treating brain tumors and epileptic foci.
The Plymouth, Minn.-based company said that the newly cleared laser probe replaces previous generation’s metal thermocouple inside the laser probe with a non-metallic fiber optic temperature sensor to eliminate the risk of unintended probe heating. The shift to non-metallic patient contacting components means that MR-scan restrictions, which were issued last year, have been removed.
Monteris touted that the newly cleared probe allows the operator to customize trajectories during surgical planning and positioning, which can be helpful for reaching challenging target locations.
“This is an important milestone for Monteris Medical, as well as the neurosurgeons and patients we serve. 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,” prez & CEO Martin Emerson said in a press release.
In March, the FDA issued a recall for select NeuroBlate systems and laser delivery probes over issues with unexpected heating and damage to the tip of the probe that could cause serious injuries.
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Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Monteris Medical Source Type: news