Abstract: The present invention provides combination therapies for treating a metabolic disorder, such as type 2 diabetes, obesity, and related comorbidities (e.g., NASH or NAFLD)) in an individual undergoing treatment with a gastrointestinal implant. The combination therapies described herein include methods for treating an individual with a gastrointestinal implant with a metabolic agent, a bariatric procedure, and/or a microbiota modulator.

Abstract: The present invention provides methods of predicting and monitoring treatment with a gastrointestinal implant (e.g., a gastrointestinal sleeve), including efficacy and complications associated therewith (e.g., complications attributed to the gastrointestinal implant or occurring concurrently with, but independent from, the gastrointestinal implant). Further provided are methods of determining a time point for removing a gastrointestinal implant (e.g., based on one or more biomarkers, e.g., biomarkers associated with safety and efficacy).

Abstract: A delivery system for placing a gastrointestinal device in a mammalian gastrointestinal tract comprises a container assembly; a gastrointestinal implant device that includes proximal and distal ends stored within the container assembly, the proximal end including an anchor and the distal end including a sleeve, coupled to the anchor and folded into the container assembly; and an inner extension to draw a portion of the sleeve from the anchor and from the container assembly as the anchor is retained therein. The inner extension comprises an atraumatic tip, such as a ball, that includes a guidewire rail. Further, a handle is provided that retains or captures an inner catheter within the handle. Within the handle is an elongated element that surrounds a portion of the catheter. A button on a side of the handle is configured to cause engagement of the catheter via the element when the button is depressed.