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Fiagon Receives FDA Clearence for ENT Instruments

Berlin, GERMANY (March 22, 2016) – Fiagon AG medical technologies announced today that it received U.S. Food and Drug Administration (FDA) clearance for new ENT instruments. The clearance includes, PointerShell Lightseeker, Universal PointerShell and Lo-Pro GuideWire 0,6mm.



“Now we have the clearance for our complete ENT instrument portfolio and are prepared to set our focus on the ENT hospital market in the U.S.”, said Dr. Timo Krüger, CEO Fiagon AG.



Fiagon´s Navigation system uses an electromagnetic tracking system to locate surgical instruments during a surgery in relation to a patient´s CT scan. The use of surgical navigation tools allows surgeons to significantly reduce the risk to patients of each intervention and shorten surgery time by reducing the number of instrument changes.



Fiagon’s technology includes instruments that have a proprietary “chip on the tip” technology, including bendable instrumentation to reach challenging anatomy.



The navigation set for ENT interventions is designed to provide surgeons with flexibility and easier navigation of sinus surgeries (e.g. FESS), ear (e.g., lateral scull base), plastic reconstructive surgery and tumor navigation.



In addition, the ENT navigation unit can be easily integrated into any endoscopic tower or microscope.



The clearance includes the following instruments:


  • PointerShell Lightseeker
  • Universal PointerShell
  • Lo-Pro GuideWire 0,6mm
  • BiopsyPointer



The instrument set previously received regulatory clearance in EMEA, Australia and Russia. It is currently sold in more than 50 countries worldwide.


“With the new regulatory clearance we will bring a wider range of surgical navigation tools to surgeons in the U.S. and continue our expansion in the North American market, said Wolfgang Urbild, President of Fiagon NA Inc. “The Lo-Pro GuideWire has been exclusively designed for Entellus Medical Inc., our cooperation partner in the ENT office sector to enhance navigated balloon dilation products.”



Fiagon´s smart system with a small footprint, enables surgeons to increase patient safety during standard and critical ENT procedures.



Fiagon NA Inc., with U.S. headquarters in Austin, Texas, is a manufacturer of clinical navigation systems. With the proprietary “FlexSensor” technology, Fiagon develops and produces unique surgical navigation systems of the latest generation.





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