Laser neurosurgery tool receives Health Canada license as Class 4 medical device
Monteris Medical (Winnipeg, MB, Canada)'s NeuroBlate system, a minimally invasive robotic laser thermotherapy tool, has received Health Canada License as a Class 4 Medical Device. NeuroBlate, which is the first and only minimally invasive robotic laser thermotherapy tool available in Canada, employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and other neurological soft tissue lesions.
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NeuroBlate pairs magnetic resonance imaging (MRI) and software-based visualization to allow surgeons to remotely ablate tumors in many locations in the brain, at the surface or deep inside, through a computer module. With the system, a surgeon makes a small hole in the skull, approximately as wide as a pencil. The surgeon then precisely guides the small laser probe via an MRI-compatible robotic driver to apply controlled amounts of heat to the targeted lesion, until the tissue is destroyed.
With its minimally invasive and image-guided approach, the NeuroBlate system has shown results analogous to open surgery.1 Patients undergoing procedures with the system may experience less pain compared with those undergoing open surgical procedures and reduced hospital length of stay over open surgical procedures.1-3
Cleared by the FDA in April 2013, the NeuroBlate system has been used in more than 275 surgical procedures in American institutions across the country, including Cleveland Clinic, UC San Diego Health System, Barnes Jewish Hospital, Washington University, and Yale New Haven Hospital.
Already licensed in Canada are Monteris' AXiiiS stereotactic anchoring device for image-guided trajectory alignment and the AtamA Stabilization System for MR-based procedures requiring versatile head fixation.
Monteris Medical supports the installation of new systems with comprehensive hands-on training, ongoing technical support and awareness/outreach resources. In collaboration with its physician network, the company is also continuing to contribute to the body of knowledge about the NeuroBlate system in scientific settings with ongoing peer-reviewed studies and reports.
REFERENCES
1. A. H. Hawasli et al., Neurosurgery, 73, 6, 1007–1017 (Dec. 2013).
2. A. E. Sloan et al., J. Neurosurg., 118, 6, 1202–1219 (June 2013).
3. A. M. Mohammadi and J. L. Schroeder, Expert Rev. Med. Devices, 11, 2, 109–119 (2014).
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