Authors: Xavier Jean MD, Kate Lak MD
Origami Surgical received FDA approval for the StitchKit® COMBO Suture Delivery Canister in February 2021.
The StitchKit® COMBO Suture Delivery Canister is a device that assists in transporting suture to the operative field and removing needles after suturing in minimally invasive robotic surgery cases. This device allows passing of multiple needles and different types of suture at once with safe retrieval using a clear sharps container that additionally allows for accurate needle counts during the case. The Stitchkit® device can be delivered through any trocar that is ≥ 12 mm. Once delivered, the Stitchkit® can be opened using the large tabs on either end of the device. At the end of the case, the canister is closed and can be retrieved using an attached retrieval string, removing all needles at once. The system is intended to improve safety, increase efficiency, and enhance autonomy.
The StitchKit® platform including the canister containing the suture and integrated sharps container has previously been approved by the FDA. This new FDA approval involves novel combinations of both absorbable and nonabsorbable sutures contained within the canister that are commonly used in robotic cases. The suture materials were provided by their corresponding manufacturers without modifications from Origami Surgical. The combinations of sutures were designed with input from leading surgeons in urology, general surgery, and bariatric surgery to develop the following three different combinations of suture contained in the Stitchkit® canister:
- StitchKit® COMBO SK-103: Polysorb®, Vloc™-180, and Vloc™-90
- StitchKit® COMBO SK-104: Polysorb®, SofSilk®, and Vloc™-90
- StitchKit® COMBO SK-105: Polysorb®, and Vloc™-90
The FDA has determined that this product is substantially equivalent to the previously approved StitchKit canister and the included suture material. This product is indicated for use in minimally invasive robotic surgery cases in which the use of the specific suture contained in the StitchKit® COMBO Suture Delivery Canister is appropriate for the case. The device cannot be introduced through ports <12 mm in size.
