Fortimedix Surgical tells us it has received CE Mark approval for 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.
Background
Netherlands-based Fortimedix Surgical says it is is aiming to challenge the status quo in minimally invasive surgery by creating novel devices that capture the claimed benefits of single-port surgery. With a strong history as a global market leader in contract stent manufacturing, the company is committed to minimally invasive surgery and is looking to deliver smart innovation across surgical specialties.
FMX314 claims to address unmet needs in laparoscopic surgery by providing a platform solution that is small, simple and secure. 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.
Fortimedix will launch FMX314 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.
Company comments
“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.”
Source: Globe Newswire
published: October 4, 2016 in: Approval/Clearance, General Surgery, Gynaecology/Obstetrics