A device completely disposable within a bodily lumen of a patient and for controlling flow through the bodily lumen having a device body having a proximal end, a distal end and a device lumen within the device body extending from the proximal end to the distal end and a fixation element extending from the outer wall of device body adapted and configured to engage with the wall of the bodily lumen. The device body is adapted and configured to move from a position where the device lumen blocks flow through the bodily lumen to a position where the device lumen allows flow through the bodily lumen. In other configurations, there are one or more valves within the device lumen adapted and configured to move between a position to block flow through the bodily lumen and a position to allow flow through the bodily lumen. There is also a method for implanting a device within a body lumen by placing a device having a device body and fixation elements extending from the device body on a catheter and then dilating the body lumen such that the device body and the fixation elements may advance through the dilated body lumen without the fixation elements engaging the wall of the body lumen. Next, advancing the device to an implant site within the body lumen and then engaging the walls of the body lumen with the fixation elements.