Fortimedix Surgical, a company with offices in Nuth, The Netherlands and Rancho Santa Fe, California, won FDA clearance to bring to market its FMX314 laparoscopic surgical system. The device provides surgeons the opportunity to use two instruments at once via a single port in the abdomen.
The device is inserted via a standard 15 mm trocar, while controls outside the body closely mimic traditional laparoscopic equipment that make it seem like two different tools within their own trocars are being used. Since the port is a common size and doesn’t require a wider incision, patients will hopefully benefit from fewer complications, quicker recovery with less pain, and reduced scarring. For surgeons the benefits are the need to punch only one hole and intuitive operation they’re already used to. The company also believes that hospitals will see lower usage of analgesics and fewer readmissions for hernias and incision-site infections.
The company plans to begin making the FMX314 available for purchase toward the end of October this year in conjunction with the ACS Clinical Congress 2016 in Washington, DC.
“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,” commented Mr. Wout Bijker, CEO of Fortimedix Surgical.
Via: Fortimedix Surgical…