Fiagon Receives FDA Clearance For Brain Surgery

BERLIN, April 22, 2016 /PRNewswire/ -- Fiagon AG medical technologies announced today that it received U.S. Food and Drug Administration (FDA) 510k clearance for its brain navigation software. The clearance includes the company's navigation system and software, BiopsyPointer FlexPointer 1.5 and the ShuntPointer.

Fiagon´s Navigation system uses an electromagnetic tracking system to locate surgical instruments during a surgery in relation to a patient´s CT scan. Fiagon's technology includes instruments that have a proprietary "chip on the tip" technology, including bendable instrumentation to reach challenging anatomy. 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 navigation set for brain interventions is designed to provide surgeons with flexibility and easier navigation of craniotomies (e.g. tumor resection), skull base procedures, cranial biopsies and general catheter placement. They include:

• Navigation module with Navigation software
• Navigation sensor (headrest/articulating arm with field generator)
• Navigation instrument
• Patient reference localizer (with fixation material)
• ShuntPointer
• FlexPointer 1.5
• BiopsyPointer

The Brain navigation system and instrument set received previous 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. "Fiagon´s smart system with a small footprint, enables surgeons to increase patient safety during standard and critical brain surgeries."

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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