Gastric Electrical Stimulation for the Treatment of Gastroparesis and Obesity
DESCRIPTION
Gastric electrical stimulation (i.e., gastric pacing, gastric pacemaker) is performed using an implantable device designed to treat chronic drug-refractory nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The device (i.e., Enterra™ Therapy System) consists of four components: the implanted pulse generator, two unipolar intramuscular stomach leads, the stimulator programmer, and the memory cartridge. The intramuscular stomach leads are implanted either laparoscopically or during a laparotomy and are connected to the pulse generator that is implanted in a subcutaneous pocket. The programmer sets the stimulation parameters.
Gastroparesis is a chronic disorder of gastric motility characterized by delaying emptying of a solid meal. Symptoms include bloating, distension, nausea and vomiting. Severe and chronic, gastroparesis can be associated with dehydration, poor nutritional status and poor glycemic control in diabetics. While most commonly associated with diabetes, gastroparesis is also found in chronic pseudo-obstruction, connective tissue disorders, Parkinson's disease, and psychological pathology. Treatment of gastroparesis includes prokinetic agents such as cisapride and metoclopramide, and antiemetic agents such as metoclopramide, granisetron, or ondansetron. Severe cases may require enteral or total parenteral nutrition.
Gastric electrical stimulation has also been investigated for the treatment of obesity as a technique to increase a feeling of satiety with subsequent reduced food intake and weight loss. The exact mechanisms that result in changes in eating and behavior are uncertain. The mechanisms may be related to neuro-hormonal modulation and / or stomach muscle stimulation.
POLICY
Gastric electrical stimulation for the treatment of gastroparesis or obesity is considered investigational.
See also:
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ADDITIONAL INFORMATION
The data is inadequate to permit scientific conclusions regarding the application of gastric electrical stimulation for the treatment of gastroparesis or obesity.
Currently, there is only one gastric electrical stimulator that has received approval from the U.S. Food and Drug Administration (FDA), the Enterra™ Therapy System (i.e., Gastric Electrical Stimulator [GES]), manufactured by Medtronic, Inc. This approval is for the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The FDA approval was given through a "humanitarian device exemption." This regulatory category was established in 1996 and only applies to devices intended to benefit less than 4,000 patients. The approval process is similar to that of a pre-market approval application (PMA), but is exempt from the effectiveness requirements of a PMA. Thus, the application is not required to provide results of scientifically valid clinical investigations, but must contain sufficient information for the FDA to determine that the device does not pose unreasonable or significant risk of illness or injury. A humanitarian use device may only be used in facilities that have an Institutional Review Board (IRB) to supervise clinical testing of the device.
SOURCES
American Gastroenterological Association. (2004, November). American Gastroenterological Association medical position statement: Diagnosis and treatment of gastroparesis. Retrieved July 13, 2010 from http://download.journals.elsevierhealth.com/pdfs/journals/0016-5085/PIIS0016508504016336.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (6:2009). Gastric electrical stimulation (7.01.73). Retrieved July 13, 2010 from BlueWeb. (19 articles and/or guidelines)
Greenway, F., & Zheng, J. (2007). Electrical stimulation as treatment for obesity and diabetes. Journal of Diabetes Science and Technology, 1 (2), 251-259.
Lin, Z., Sarosiek, I., & McCallum, R. W. (2007). Gastrointestinal electrical stimulation for treatment of gastrointestinal disorders: gastroparesis, obesity, fecal incontinence, and constipation. Gastroenterology Clinics of North America, 36 (3), 713-734.
National Guideline Clearinghouse. (2007, April). Endoscopy in patients with implanted electronic devices. Retrieved July 13, 2010 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2004, December). Gastroelectrical stimulation for gastroparesis. Retrieved July 13, 2010 from http://www.nice.org.uk/nicemedia/live/11130/31201/31201.pdf.
Sallam, H. S., Chen, J. D., & Pasricha, P. J. (2008). Feasibility of gastric electrical stimulation by percutaneous endoscopic transgastric electrodes. Gastrointestinal Endoscopy, 68 (4), 754-759.
U. S. Food and Drug Administration. (2000, March). Medical devices. Enterra™ therapy system (formerly named gastric electrical stimulation (GES) system) - H990014. Retrieved July 13, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H990014.
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, April). Gastric electrical stimulation for gastroparesis. Retrieved July 13, 2010 from www.Hayesinc.com/subscribers. (34 articles and/or guidelines reviewed)
Zhang, J., & Chen, J. D. (2006). Systematic review: applications and future of gastric electrical stimulation. Alimentary Pharmacology & Therapeutics, 24 (7), 991-1002.
ORIGINAL EFFECTIVE DATE: 8/10/1998
MOST RECENT REVIEW DATE: 8/12/2010
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