Germany-based Fiagon AG medical technologies has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ear, nose and throat (ENT) Extended Instrument Set.
The approval has been received for the firm’s tip-navigated GuideWire, PointerShell instrument adaptor and FlexTube navigated suction and irrigation.
The instrument set has been developed to provide surgeons with flexibility and easier navigation of open or endoscopic (transnasal) ENT procedures.
The GuideWire has a diameter of 0.8 mm, which allows surgeons position a balloon during sinus dilation procedures under CT guidance, while the PointerShell uses an automated calibration process to turn a cylindrical rigid instrument, such as a shaver blade, into a navigated tool within seconds.
The FlexTube can be easily bent to any angle, enabling suction and irrigation to all nasal sinuses without the need to exchange instruments.
Fiagon said that its instruments feature chip on the tip technology, including bendable instrumentation to reach challenging anatomy.
The ENT Extended Instrument Set has also been approved in Europe, China, the Middle East and South Korea, and is currently sold in around 40 countries across the globe.
Fiagon also noted that it has established US headquarters in Austin, Texas, to further its expansion into North America.
Fiagon chief sales officer Wolfgang Urbild said: "Our new headquarters and distributor partners will help us continue to grow as we seek additional regulatory approvals."