Authors: Marguerite Ballou, MD; Nova Szoka, MD
Elucent Medical received FDA approval for the EnVisio™ Navigation System on March 22, 2019.
The EnVisio™ Navigation System is a technology that detects the presence of a SmartClip™ Soft Tissue Marker using an electromagnetic localization system. The SmartClip™ is a permanent marker inserted percutaneously at a biopsy site or a soft tissue site intended for surgical removal. The Envisio™ Navigation System identifies the SmartClip™ in real time, analyzing electromagnetic signatures that display the relative distance, depth, and direction to the implanted SmartClip™. The system can provide three-dimensional navigation for up to three separate SmartClips, each programmed to emit a unique electromagnetic signature. The Navigation System components are the Console, Heads Up Display, Patient Pad, and Foot Pedal.
Performance testing, including verification of system design and navigation performance, as well as validation of navigation performance, was performed to support a determination of substantial equivalence to predicate device, the SAVI Scout Reflector and SAVI Scout System made by Cianna Medical, Inc.
Intended for the non-imaging detection and localization (by navigation) of the SmartClip™ that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
Intended for use in adult patients in an intra-operative setting.