Cysto-Gastro-Sets are intended to create a transgastric, transduodenal or transpapillary access in the context of biliary or pancreatic fluid collections drainage.
The claimed clinical performance is that the Cysto-Gastro Sets allow an effective cyst puncture and dilation prior to the placement of drainage devices (stents) (success rate >90%). The sets are specifically indicated for the drainage of Pancreatic Fluid Collections (PFCs). In this endoscopic procedure, puncture and dilation enable the creation of a fistulous tract between the PFC and the gastrointestinal lumen, allowing subsequent placement of an endoprosthesis (stent) to achieve effective drainage.