Hot on the heels of last week’s announcement of its CE marking, Fortimedix Surgical has now announced the first-in-man use in the United States of FMX314, the world’s first single-port surgery solution that is compatible with a standard 15mm trocar for use in minimally invasive abdominal laparoscopic surgery.
FMX314 emulates conventional, multi-port laparoscopy, making it easy to use and enabling surgeons to perform procedural steps ergonomically, which allows for a comfortable and secure single-port approach.
Following recent receipt of U.S. FDA 510(k) clearance and CE Mark approval, 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. The European commercial launch is planned for 2017.
The first U.S. cases were two laparoscopic cholecystectomy procedures, performed through the umbilicus with the Fortimedix Surgical system by renowned surgeon Santiago Horgan, MD, professor of surgery and chief of minimally invasive surgery at UC San Diego Health.
“In my experience, the FMX314 surgical platform addresses unmet needs in minimally invasive surgery by delivering benefits to patients and physicians over more invasive, laparoscopic methods,” said Dr. Horgan. “The single-port platform allows physicians to offer patients a minimally invasive treatment option that could potentially result in fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis in comparison to conventional multi-port laparoscopic surgery.”
Source: Globe Newswire