Medtronic won FDA approval under the humanitarian device exemption (HDE) provision to treat symptoms of chronic, intractable nausea and vomiting resulting from diabetic gastroparesis or other cause when traditional treatments haven’t worked. The Enterra II neurostimulator is placed within the lower abdominal wall with two leads snaking to the stomach muscle. The neurostimulator sends regular electrical signals through the leads to energize the smooth muscles of the lower stomach. After implantation the device is programmed remotely and can be turned on and off using the wireless controller.
The new device improves on the previous model, approved since 2000, by having new software that aids in programming, a new implantation tool that simplifies the process, and a new battery life indicator that promises more accurate estimates of the remaining power.
Here’s a video from the Nebraska Medical Center presenting Enterra therapy (using the original Enterra neurostimulator):
Product page: Enterra II Neurostimulator…