Fiagon Receives FDA 510(k) Clearance for Pediatric Catheter Shunt Placement
Austin, TX - September 29, 2017 - Fiagon AG today announced 510(k) clearance for the indication of Pediatric Catheter Shunt Placement from the United States Food and Drug Administration (FDA) expanding procedural support to include non-fixed surgical procedures. Fiagon is an IGS company driven by the belief that every minute and every millimeter matters. By compressing the traditional navigation system into a powerful, compact unit – small enough to fit in a preexisting endoscopic tower – Fiagon provides more room around the operating table. To maximize surgeon control, Fiagon offers innovative instruments that can be manipulated, bent, and reshaped while maintaining best-in-class accuracy.
“Fiagon has revolutionized the way IGS is valued and used in everyday rhinologic procedures; specifically, in the rapidly evolving office market space. We are excited to bring that same innovative technology and approach to the field of cranial surgery,” said Matt Jones, VP Sales & Marketing, North America.
The strategic addition to the portfolio will allow Fiagon to expand the range of care for patients in need, including pediatrics. In response to the indication clearance, Fiagon will explore opportunities for strategic partnerships with distributors and neuro surgeons.
With the recent indication approval, the Fiagon Cranial Navigation platform now offers the surgeon greater flexibility and more control than ever before. In addition to supporting non-fixed surgical procedures, Fiagon continues to support rigid fixation shunt catheter placement, biopsies, craniotomies, and skull base procedures.
Fiagon is an electromagnetic based surgical navigation company that seeks to improve patient outcomes by enabling physicians with easy-to-use, integrated navigation solutions. We have meticulously engineered a smart, intuitive, and simple navigation system that tracks Fiagon surgical instruments directly at the tip. Further, we pursue innovation by centering our development process around the physician, delivering navigation solutions that allows seamless, unobtrusive integration into their surgical environment. In sum, we at Fiagon pride ourselves in our revolutionary approach to surgical navigation, providing physician and patient value simultaneously.