“Our company is poised for significant growth, as we continue to achieve regulatory milestones to introduce innovative surgical instruments in key markets around the world,” said Marc van de Graaf, VP Global Business Development of Fortimedix Surgical. “Following 510(k) clearance from the United States Food and Drug Administration last August, this CE Mark allows us to expand the availability of our innovative technology to patients in Europe, who will benefit from the unique advantages of FMX314.”
Because it is the first single-port platform that is compatible with a standard 15mm laparoscopic trocar, FMX314 holds the promise of fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis compared with conventional multi-port laparoscopic surgery.
FMX314 emulates conventional, multi-port laparoscopy, making it easy to use and enabling surgeons to perform procedural steps ergonomically, allowing for a comfortable and secure single-port approach.
FMX314 will be launched in the U.S. during the American College of Surgeons (ACS) Clinical Congress, taking place October 16 – 20, 2016 in Washington, D.C. at booth #1139. A European commercial launch is planned for 2017.
Note: FMX314 is the engineering code name for symphonX™ used during the pre-commercial phase.