FDA OKs Label Expansion for Origami Surgical’s StitchKit

Origami Surgical has obtained U.S. Food and Drug Administration (FDA) clearance for insertion and removal of its StitchKit device.
 
The new indication enables insertion and removal through any existing 8 mm trocar incision while the surgeon watches the action on the laparoscope, allowing StitchKit use when no 12 mm trocars are in use. The technique involves removing one 8 mm trocar followed by direct placement of StitchKit into the surgical field through the trocar incision.
 
At the end of the case, the surgeon removes StitchKit with the retrieval string, pulling it flush to robotic trocar and removing the trocar and StitchKit as one unit.
 
“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,” Sean McNerney, CEO of Origami Surgical told the press.
 
The StitchKit portfolio is designed to enhance robotic-assisted surgery by letting the surgeon manage all aspects of suture use and needle disposal in clear view. It’s placed in the peritoneal cavity and used at the robotic surgical console. StitchKit has all the sutures required for the given robotic procedure, plus a SHARPS container where used needles are place throughout the case.
 
After the surgery, StitchKit is removed from the surgical field with used needles stored safely inside. StitchKit, in summary, eliminates suture and needle passing by the bedside assistant to save time and eliminate needle loss inside the patient.