Author: Timothy Snow, DO
FreeHold Surgical received FDA approval for the Trio Hands-Free Intracorporeal Retractor on August 15, 2014.
The FreeHold TrioTM intracorporeal retractor is a single-use device, which can be inserted through a 5mm laparoscopic trocar and used to assist with tissue retraction. The FreeHold TrioTM is most appropriate for use in sling-style retraction, such as retraction of the liver or uterus. The adjustable retractor provides the surgeon with autonomy by optimizing visualization without the addition of extra incisions for other types of retraction devices. Additional benefits include ease of insertion/removal, broad range of tissue retraction, and simplicity of adjustment without device repositioning.
The retractor consists of hooks, suture, and a pulley system in order to suspend tissue away from the operative field. It can easily be introduced and removed through existing 5 mm trocars. During the operation, the hooks are strategically positioned, and the retractor can be manipulated to conform to the patient’s anatomy.
The device has been approved as a FDA Class 1 device and has met all the requirements for such a product. Studies comparing liver retraction techniques suggest that suture suspension devices may result in decreased post-operative pain[i],[ii] and decreased liver dysfunction[iii] compared to other instrument retraction devices.
According to the FDA, the FreeHold TrioTM is a modification of previously applied simple suture suspension methods utilized by surgeons for retraction. The device eliminates the need for intracorporeal suturing and allows for the adjustment of suture length throughout the procedure.
The FreeHold TrioTM is FDA approved for retraction of internal organs during laparoscopic and robotic surgical procedures including but not limited to cholecystectomy, hiatal hernia repair, gastrectomy, sleeve gastrectomy, Roux-en-Y gastric bypass, and duodenal switch.
The FreeHold TrioTM is contraindicated for patients who are unable to safely tolerate laparoscopic or robotic surgery and should not be used for nerve or vessel retraction.
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