The Netherlands-based medical device company Fortimedix Surgical has received US Food and Drug Administration (FDA) 510(k) clearance for its single-port platform, FMX314, to be used for minimally invasive abdominal laparoscopic surgery.
FMX314 is developed as a single-port surgery solution compatible with a standard 15mm laparoscopic trocar, with fewer port-site complications. It helps in reducing hospital readmission rates, while treating hernias and infections.
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The procedure involves less incisions, which results in a faster recovery, and a reduction in the use of analgesics, thereby improving overall procedural efficiency.
Fortimedix Surgical CEO Wout Bijker said: "We are very pleased to announce we have secured 510(k) clearance for our platform, as it signifies an important milestone in our quest to deliver on the promise of single-port surgery.”
Patients benefit from less post-operative pain, faster recovery rates, and less scarring.
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The device, measuring 15mm, is easy to use and allows surgeons to conduct procedural steps in an ergonomic manner, while paving the way for a comfortable and secure single-port approach, based on the procedures of a conventional laparoscopy.
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By GlobalDataThe company is expecting to release FMX314 in the US during the ensuing ACS Clinical Congress 2016 in Washington, DC.
