Enterra Therapy: gastric neurostimulator for gastroparesis.
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.
Gonzalez
Humberto C
HC
Henry Ford Hospital, Detroit, MI 48202, USA.
Velanovich
Vic
V
D002986:Clinical Trials as Topic; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D004560:Electricity; D018589:Gastroparesis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D013270:Stomach / Q000503:physiopathology