Fiagon Receives FDA Clearance for ENT instrument FlexPointer 1.5

Saturday, April 23, 2016

Fiagon AG medical technologies announced today that it received U.S. Food and Drug Admiration (FDA) 510(k) clearance for its ear, nose and throat (ENT) FlexPointer 1.5 instrument. The clearance includes the company’s tip-navigated Pointer instrument, FlexPointer 1.5.

Fiagon’s FlexPointer is designed to provide surgeons with flexibility and easier navigation of open or endoscopic (transnasal) ENT procedures:

“The 1.5mm FlexPointer is another big Step for Fiagon in office market where „small“ is paramount,” said Matt Jones, Fiagon´s Marketing & Sales Director North America. “The instrument easily bends and can be used as a navigated malleable seeker throughout a typical sinus procedure.” Jones went on to say Fiagon anticipates the 1.5mm FlexPointer to increase Fiagon’s presence and versatility in the U.S. Office market for ENT procedures. “This adds another valuable instrument to the growing line of Fiagon products.”

• The FlexPointer 1.5 has a diameter of 1.5 mm and helps surgeons position the instrument during procedures under CT guidance.

Fiagon’s Navigation system uses an electromagnetic tracking system to locate surgical instruments during an operation relative to a patient’s CT scan. Fiagon’s instruments have a proprietary “chip on the tip” technology, including bendable instrumentation to reach challenging anatomy. The use of surgical navigation tools allow surgeons to significantly reduce the risk to patients of each intervention and shorten operation time by reducing the number of instrument changes.


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