Fiagon's ENT Extended Instrument Set receives FDA approval

Fiagon AG medical technologies announced today that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ear, nose and throat (ENT) Extended Instrument Set. The clearance includes the company's tip-navigated GuideWire, PointerShell instrument adaptor and FlexTube navigated suction and irrigation. The company also announced that it has established U.S. headquarters in Austin, Texas, to further its expansion into North America.

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.

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

• The GuideWire has a diameter of 0.8 mm and helps surgeons position a balloon during sinus dilation procedures under CT guidance.
• 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 is easily bent to any angle, enabling suction and irrigation to all nasal sinuses without the need to exchange instruments.

The ENT Extended Instrument Set received previous regulatory clearance in Europe, China, the Middle East and South Korea. It is currently sold in more than 40 countries worldwide.

"The new regulatory clearance allows us to bring a wider range of surgical navigation tools to surgeons in the U.S. and continues our expansion into the North American market," said Matt Jones, Fiagon's North American director of sales and marketing. "Fiagon's small yet smart system enables surgeons to use the same safety standards in the office as in the hospital. As procedures continue to shift into an office environment, Fiagon's easy-to-use system can integrate seamlessly into the surgeon's office."

Edwin K. Chan, MD, Attending Surgeon, Department of Otolaryngology - Head & Neck Surgery, The New York Eye & Ear Infirmary of Mount Sinai, New York, was the first U.S. physician to use the Fiagon system in his office for sinus procedures. "In-office navigation is integral to the natural evolution of less invasive sinus surgery. Procedures are now moving from being performed in the OR to the convenient setting of the office. Knowing exactly where the tip of the balloon instrument is during sinus dilation provides an extra layer of safety for the patient, and helps surgeons know they are effectively dilating the sinus drainage pathway."

Dr. Chan went on to say that in-office navigation can potentially expand the surgeon's armamentarium of what can safely be done in the office, including partial ethmoidectomy and polypectomy procedures. "The intuitive interface, ease of use, and portability of the Fiagon System make it ideal for in office use."

Fiagon's new North American headquarters office in Austin is its first step toward establishing a U.S. retailer network and distribution channels for the device. Jones will lead the new office. Fiagon also has partnered with several well established medical device distributors in North America, including: ABS Medical, Precision Surgical, Surgical One, Micro Image Technologies, Nautilus Surgical, Day Surgical, Surgical Specialties, Neuro Dynamics and Neuro-Tec.

"The U.S. market is a key focus for us as we continue to expand globally," said Wolfgang Urbild, Fiagon's chief sales officer. "Our new headquarters and distributor partners will help us continue to grow as we seek additional regulatory approvals."