Origami Surgical announced today that it received FDA clearance for the insertion and removal of its StitchKit device.
Madison, New Jersey-based Origami’s new FDA indication allows for insertion or removal through any existing 8mm trocar incision while the surgeon watches the action via the laparoscope. This allows for StitchKit use even with no 12mm trocars in use.
According to a news release, the technique requires the removal of one 8mm trocar. The surgeon then directly places the StitchKit into the surgical field through the trocar incision. At the case’s conclusion, the surgeon removes StitchKit via the retrieval string, Origami said. The surgeon pulls it flush to robotic trocar and removes the trocar and StitchKit as a unit.
Origami designed its StitchKit technology to enhance robotic-assisted surgery. It allows the surgeon to manage all aspects of suture use and needle disposal in clear view. The technology provides safety, autonomy and efficiency in robotic surgery.
StitchKit eliminates exposed needle transfer and provides a transparent, secure receptacle area to capture used needles. It also features a pre-loaded suture delivery canister housing six sutures and needles for rapid access.
“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,” said Sean McNerney, CEO of Origami Surgical.