FDA Greenlights Label Expansion for Origami Robotic StitchKit Device

The FDA has cleared a label expansion for Origami Surgical’s StitchKit robotic surgery device for insertion and removal through an 8 mm trocar incision while the surgeon is watching the robot’s actions through a laparoscope.

The surgeon places the robotic device into the peritoneal cavity and manipulates the device from a console. The StitchKit contains all the sutures needed plus a sharps container for used needles.

At the end of the surgery, the surgeon removes the device with the needles stored safely inside, eliminating the potential for needle loss inside the patient.

“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 Origami Surgical CEO Sean McNerney.