AUSTIN, Texas, (April 23, 2015) — 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 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.