Authors: Sarah Assali DO & Nova Szoka MD
Standard Bariatrics received FDA approval for the Standard Clamp in October, 2016.
The Standard Clamp is a device intended for use in laparoscopic sleeve gastrectomy to clamp the entire length of the stomach. It is a single-use, non-energized, laparoscopic clamp designed to help the surgeon establish a predictable and reproduceable gastric sleeve size, shape, and volume. This disposable, manually articulated, device is designed to fit through a 12mm trocar and has 3 main sections: handle, shaft, and end effector. The clamp has upper and lower jaws, 25cm in length and 1cm in width, that close in parallel to grasp tissue.
Preclinical evaluation included testing in a porcine model to gauge the Standard Clamp’s ability to clamp gastric tissue without damaging it in comparison to other laparoscopic graspers and clamps that are currently available. Tissues were observed in vivo to visualize the effect when being clamped and released. Initial clinical data suggest that the Standard Clamp may achieve fewer stapler firings when compared with the number of staple firings used in traditional sleeve gastrectomy technique.
The FDA determined this device is substantially equivalent to predicate devices on the market.
