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Synaptive Medical Wins FDA Clearance for Groundbreaking Surgical System Brightmatter™ Guide

New Neuro-Navigation System Brings Unprecedented 3D Views of Brain Tractography into the Operating Room

WASHINGTON (April 7, 2015) — Following months of review, the US Food and Drug Administration cleared Synaptive Medical’s BrightMatter Guide system for use in US operating rooms. Hospitals and surgical facilities will now be able to incorporate this game-changing surgical navigation system from Synaptive, the Toronto-based creator of leading edge neurosurgery products, into their clinical workflow.

BrightMatter Guide is a neuro-navigation system that displays 3D tractographic visuals of the brain in the Operating Room, to aid surgeons in guiding their tools and informing their surgical approach. This trajectory-centric navigation system fully considers that the path through the brain is as important as the destination itself. The 3D DTI visuals, carefully overlaid on an anatomical scan, provide valuable information allowing surgeons to visualize the brain’s internal networks. In addition, BrightMatter Guide provides continuous tracking of multiple tools throughout a procedure for real-time location updates within the surgical cavity.

When BrightMatter Guide is interfaced with Synaptive’s BrightMatter Vision and BrightMatter Drive technologies, it forms a compelling solution in the operating room called Servo. Servo mounts a powerful optics platform onto an automated positioning system for use with BrightMatter Guide. These technologies – Guide, Vision, and Drive are designed to work in concert to allow a surgeon far greater flexibility in both the navigation and execution of a complex surgery.

Specifically, the BrightMatter Servo solution allows a surgeon to:

  • Automatically track surgical tools with Drive, using a robotic arm to keep optics and light externally aimed where they are most needed.
  • Replace cumbersome optics with Vision for a collaborative and accessible surgical field with great resolution and a high depth of field.
  • Evaluate a surgical plan in the operating room with Guide; 3D tractography and other advanced visualizations that are available for navigation using a surgical trajectory.

“BrightMatter Guide is a GPS of sorts for the brain, giving surgeons a visual representation of the complex structures and associated tractography of the brain in the operating room, where they need them.” said Cameron Piron, President of Synaptive Medical. “Combined with our other technologies, Synaptive can streamline the entire procedure, from pre-operative imaging to post-operative evaluation. We are providing surgeons with the tools to adapt to the changing surgical environment, integrating imaging modalities and technologies as they are needed. I am looking forward to seeing Guide successfully used in operating rooms around the country.”

About Synaptive Medical

Synaptive Medical has dedicated a talented team of engineers and scientists specifically to the development of neurosurgical technologies. The result is their BrightMatterTM Neurosurgical Products that provide advanced tools and information to allow surgeons to focus on patient outcomes. From advanced visualization and guidance to their first hands-free surgical scope, Synaptive medical is collaborating with surgeons, hospitals and industry partners to define a new standard of care for neurosurgical intervention.