Enterra^®Therapy: gastric neurostimulator for gastroparesis

Abstract

Gastroparesis is a chronic disorder of gastric motility characterized by delayed gastric empting in the absence of mechanical obstruction, which can lead to symptoms of nausea, vomiting, bloating, abdominal pain, postprandial fullness and weight loss. Although there are many etiologies, the primary causes are diabetes or are idiopathic. The mainstay of treatment is dietary and drug therapies. However, many patients will continue to suffer intractable symptoms despite these treatments. Gastric neurostimulation with the Enterra Therapy system has been approved for use under the Humanitarian Device Exemption by the US FDA. The device produces pulses of electrical stimulation that are delivered to the stomach continuously. One randomized clinical trial and multiple nonrandomized unblinded clinical trials and case series have documented improvement of symptoms in intractable diabetic and idiopathic gastroparesis. The purpose of this article is to introduce the Enterra Therapy gastric neurostimulator. Gastroparesis and its pathophysiology will be discussed in this clinical context to enhance the understanding of the device and its development. We will analyze the device in detail, its placement and the results of studies evaluating its efficacy.

A Novel Approach in Spinal Cord Stimulation for Enhancing Gastric Motility: A Preliminary Study on Canines

“…13,29 Alternatively, surgical treatments, such as jejunostomy tube feeding, may be used if intestinal motility is normal; however, they do not solve the main problem. GES or Enterra Therapy on the other hand for treating nausea and vomiting in gastroparesis 7 has not been very promising on overall symptoms of gastroparesis or gastric emptying. [8][9][10] All the above-mentioned treatment approaches due to their natures can address only a fraction of overall symptoms/problems and somehow exacerbate the other symptoms.…”

“…4 While the individual and societal burden of gastroparesis are substantial, currently limited treatment options are available with no satisfactory outcomes. Gastric electrical stimulation (Enterra Therapy) has been approved for humanitarian use in treating nausea and vomiting in gastroparesis, 7 however reports of efficacy have varied among different centers and some have failed to show any promising effects on overall symptoms of gastroparesis or gastric emptying. [8][9][10] On the other hand, while a number of prokinetic medications (such as cisapride) were developed to restore normal gastrointestinal motility, they have been withdrawn from the market due to their unfavorable cardiovascular safety.…”