Origami Surgical has secured an expanded clearance from the US Food and Drug Administration (FDA) for the insertion and removal of its StitchKit device, through any existing 8mm trocar incision while the surgeon is monitoring the action through the laparoscope.
The US-based medical device maker has designed the StitchKit technology to offer a clear view to allow the surgeon to handle every aspect of suture use and needle disposal during robotic-assisted surgery.
The new FDA indication allows for the use of StitchKit even when no 12mm trocars are in use.
According to the medical device maker, the technique requires the removal of one 8mm trocar, which is followed by direct implantation of StitchKit into the surgical field via the trocar incision.
The surgeon removes StitchKit at the end of the case using the retrieval string. After this, the surgeon pulls it flush to the robotic trocar and removes the trocar and StitchKit as a unit.
Origami Surgical CEO Sean McNerney said: “As many procedures have reduced port size from 12mm to 8mm, we have listened to our customers’ needs and now have regulatory clearance for the smaller 8mm insertion.”
StitchKit technology is said to offer added safety, autonomy, and efficiency while enhancing outcomes of robotic surgery.
Origami Surgical said that the robotic surgeon using the console inserts StitchKit into the peritoneal cavity. All the sutures required for the specific robotic technique are included in StitchKit, together with a SHARPS container for discarded sutures.
The used needles are stored safely within StitchKit, which is then removed from the operating room after the procedure. At the end of the surgery, StitchKit prevents the bedside helper from passing sutures or needles, which saves time and prevents needle loss inside the patient.
StitchKit delivers better safety by preventing exposed needle transfer and offering a visible, secure receptacle area to collect discarded needles, claimed the company.
Additionally, it features a pre-loaded suture delivery canister housing six sutures and needles for quick access.
