03.27.15
Fiagon AG Medical Technologies has 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.
Fiagon’s Navigation system uses an electromagnetic tracking system to locate surgical instruments during an operation relative to a patient’s computed tomography (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 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 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 system can integrate seamlessly into the surgeon’s office.”
Edwin K. Chan, M.D., attending surgeon with the Department of Otolaryngology - Head & Neck Surgery, in the New York Eye & Ear Infirmary at Mount Sinai in New York, N.Y., was the first U.S. doctor 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,” Chan said, adding that in-office navigation potentially can expand the surgeon's armamentarium of procedures that 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.”
In addition to the FDA approval, the company also announced that it has established its U.S. headquarters in Austin, Texas, to further expand into North America.
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 medical device distributors in North America, including ABS Medical Inc., Precision Surgical Inc., Surgical One Inc., Micro Image Technologies Inc., Nautilus Surgical Inc., Day Surgical, Surgical Specialties Corporation, Neuro Dynamics and Neuro-Tec Inc.
“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 grow as we seek additional regulatory approvals.”
Fiagon, a private investor-owned company based in Berlin, Germany, is the parent company of Fiagon GmbH Holding. Fiagon AG develops and manufactures latest-generation surgical navigation systems with proprietary “chip on the tip” technology. Fiagon AG surgical navigation products are sold for use in oral and maxillofacial surgery, neurosurgery, spine and dental surgery.
Fiagon’s Navigation system uses an electromagnetic tracking system to locate surgical instruments during an operation relative to a patient’s computed tomography (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.
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The FlexTube is easily bent to any angle, enabling suction and irrigation to all nasal sinuses without the need to exchange instruments.
“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 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 system can integrate seamlessly into the surgeon’s office.”
Edwin K. Chan, M.D., attending surgeon with the Department of Otolaryngology - Head & Neck Surgery, in the New York Eye & Ear Infirmary at Mount Sinai in New York, N.Y., was the first U.S. doctor 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,” Chan said, adding that in-office navigation potentially can expand the surgeon's armamentarium of procedures that 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.”
In addition to the FDA approval, the company also announced that it has established its U.S. headquarters in Austin, Texas, to further expand into North America.
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 medical device distributors in North America, including ABS Medical Inc., Precision Surgical Inc., Surgical One Inc., Micro Image Technologies Inc., Nautilus Surgical Inc., Day Surgical, Surgical Specialties Corporation, Neuro Dynamics and Neuro-Tec Inc.
“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 grow as we seek additional regulatory approvals.”
Fiagon, a private investor-owned company based in Berlin, Germany, is the parent company of Fiagon GmbH Holding. Fiagon AG develops and manufactures latest-generation surgical navigation systems with proprietary “chip on the tip” technology. Fiagon AG surgical navigation products are sold for use in oral and maxillofacial surgery, neurosurgery, spine and dental surgery.