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Gastric Electrical Stimulation

  • Education
  • Clinical Outcomes
  • Products and Procedures
  • Reimbursement and Practice Management
  • Indications, Safety, and Warnings
  • About Gastric Electrical Stimulation

    Gastric electrical stimulation is an FDA-approved* approach to treating patients with chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of idiopathic or diabetic origin.

    Therapy Overview

    For your patients who have chronic nausea and vomiting from gastroparesis, finding the right treatment can be challenging. When symptoms are refractory, expand your treatment options by evaluating whether your patient is a candidate for gastric electrical stimulation. This introduction covers how the therapy works and how it helps patients.

    What Is Gastric Electrical Stimulation?

    Gastric electrical stimulation with the Medtronic Enterra system helps control the chronic nausea and vomiting associated with gastroparesis by stimulating the smooth muscles of the lower stomach. A small, battery-powered gastric neurostimulator is implanted beneath the skin in the lower abdominal region. Leads deliver mild, controlled electrical pulses to the antrum portion of the stomach muscle wall. The system is programmed to optimize therapy for the individual patient.


    How Gastric Electrical Stimulation May Help Patients

    Prospective clinical studies show that gastric electrical stimulation may significantly reduce vomiting frequency in patients with gastroparesis of idiopathic or diabetic origin.1

    Gastric electrical stimulation may also deliver significant improvement in health-related quality of life.1

    The American College of Gastroenterology conditionally recommends** gastric electrical stimulation for compassionate treatment in patients with refractory symptoms of gastroparesis, particularly nausea and vomiting.2

    Enterra Therapy does not work for everyone. Enterra Therapy requires surgery and has risks which may include infection, bleeding, bruising, and pain at the implant site. Adverse events related to the Enterra system may include implant site pain, lead penetration, bowel obstruction or perforation, lead entanglement or erosion, irritation/inflammation over implant site and device mechanical or electrical problems. Any of these situations may require additional surgery or cause return of symptoms. Learn more about the probable benefits and risks of this therapy.

    To explore whether this therapy may be right for your patient, review the guidelines for patient selection.


    FDA-Approved as a Humanitarian Use Device

    Enterra is a proven-safe therapy that has been approved by the FDA as a humanitarian use device.

    A humanitarian use device is a medical device intended to treat or diagnose a disease or condition that affects, or is manifest in, fewer than 4,000 individuals a year in the United States. Approval is based on a determination that the device is safe and has probable benefit. Humanitarian use devices must be implanted in a medical center whose institutional review board has approved use of the device. Learn more about humanitarian use devices.


    **A recommendation is graded “conditional” when there is uncertainty about the desirable effects of an intervention outweighing the undesirable effects.

    References
    1. Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003; 125:421-28.
    2. Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L. Clinical Guideline: Management of Gastroparesis. Am J Gastroenterol. 2013;108:18-37.

    Indications and Contraindications

    Product technical manuals must be reviewed prior to use for detailed disclosures.

    Indications

    The Medtronic Enterra Therapy System for gastric electrical stimulation (GES) is indicated for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.


    Contraindications

    The Enterra Therapy System is contraindicated in patients whom the physician determines are not candidates for surgical procedures and/or anesthesia due to physical or mental health conditions. Also, diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) is contraindicated because diathermy's energy can be transferred through the implanted system (or any of the separate implanted components), which can cause neurostimulation system or tissue damage and can result in severe injury or death.

    Treating Gastroparesis Symptoms

    Gastoparesis is a neuromuscular disorder of the stomach in which food empties from the stomach more slowly than normal. There is no cure for gastroparesis, but treatment may help control its most debilitating symptoms, chronic vomiting and nausea. Learn about gastroparesis and compare treatment options.

    Impact of Chronic Nausea and Vomiting

    Patients with gastroparesis have a variety of upper gastrointestinal symptoms including chronic nausea, frequent vomiting, early satiety, abdominal bloating, and abdominal pain. These symptoms prevent the person from eating normally and may lead to dehydration, weight loss, and eventually life-threatening electrolyte imbalances and malnutrition. The impact on work, school, family, and activities is devastating for patients.

    Over time, high blood glucose levels and their metabolic effects can damage the vagus nerve and interfere with normal function. Inconsistent stomach emptying and poor absorption make blood sugar levels hard to control.


    Comparing Treatment Options

    This chart compares the use and challenges of treatments for symptoms of gastroparesis. A combination of treatments may be needed.

    Patient selection provides guidelines for recognizing candidates for gastric electrical stimulation in your practice.

    Treatment Use Challenges
    Diet modification Reduce symptoms and maintain adequate fluids and nutrition Does not relieve nausea. May not relieve vomiting.
    Prokinetic agents Improve rate of stomach emptying Up to 40% of patients cannot take prokinetic agents due to intolerable side effects. Side effects can be serious, including tardive dyskinesia and sudden cardiac death.1
    Antiemetic agents Control nausea and vomiting Have no effect on stomach emptying. May have side effects.
    Enteral nutrition Usually temporary and only when gastroparesis is severe Does not relieve nausea.
    Total parenteral nutrition Only if enteral feeding is not tolerated or is insufficient to meet caloric needs Does not relieve nausea.
    Gastric electrical stimulation Relieve chronic intractable nausea and vomiting due to gastroparesis of diabetic or idiopathic origin Requires surgery and has risks which may include infection, bleeding, bruising, and pain at the implant site**. Indications, Safety, and Warnings
    Gastrectomy After other options have failed Permanent. May not relieve nausea.

    **In addition to these risks, adverse events related to the Enterra system may include implant site pain, lead penetration, bowel obstruction or perforation, lead entanglement or erosion, irritation/inflamation over implant site, and device mechanical or electrical problems. Any of these situations may require additional surgery or cause return of symptoms.

    References
    1. Medications Used to Treat Gastroparesis. International Foundation for Functional Gastrointestinal Disorders. www.aboutgastroparesis.org. Accessed April 14, 2014.

    Why Consider GES

    When looking for new treatment options for a patient with chronic, refractory nausea and vomiting from gastroparesis, consider the probable benefits and risks of gastric electrical stimulation.

    May Reduce Vomiting Frequency

    Prospective clinical studies show that gastric electrical stimulation may significantly reduce vomiting frequency in patients with gastroparesis of idiopathic or diabetic origin.1


    May Improve Quality of Life

    Gastric electrical stimulation may also deliver significant improvement in health-related quality of life.1

    Patients may be able to eat a more normal diet, including solid foods. If symptoms greatly improve, patients may have a better quality of life. However, this therapy does not work for everyone.


    Conditionally Recommended by the American College of Gastroenterology

    The American College of Gastroenterology conditionally recommends gastric electrical stimulation for compassionate treatment in patients with refractory symptoms of gastroparesis, particularly nausea and vomiting. A recommendation is graded "conditional" when there is uncertainty about the desirable effects of an intervention outweighing the undesirable effects.

    Gastric electrical stimulation is included in the clinical guideline for the management of gastroparesis published in the American Journal of Gastroenterology.

    Clinical Guideline: Management of Gastroparesis

    "This guideline presents recommendations for the evaluation and management of patients with gastroparesis...GES may relieve symptoms, including weekly vomiting frequency, and the need for nutritional supplementation, based on open-label studies."

    Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L. Clinical Guideline: Management of Gastroparesis. Am J Gastroenterol. 2013;108:18-37.


    FDA Approved

    Gastric electrical stimulation with the Medtronic Enterra system was approved by the FDA as a humanitarian use device in 2000. Learn more.


    Reversible

    Unlike other surgical options, therapy with gastric electrical stimulation is reversible. Using the external clinician programmer, therapy can be turned on and off at any time without surgery. The device can also be explanted.


    Risks

    Gastric electrical stimulation does not work for everyone.

    Enterra Therapy requires surgery and has risks which may include infection, bleeding, bruising, and pain at the implant site.

    Adverse events related to the Enterra system may include implant site pain, lead penetration, bowel obstruction or perforation, lead entanglement or erosion, irritation/inflammation over implant site and device mechanical or electrical problems. Any of these situations may require additional surgery or cause return of symptoms. For additional safety information, please refer to Indications, Safety, and Warnings.


     

    References
    1. Abell T, McCallum R, Hocking M, et al. Gastric electrical stimulation for medically refractory gastroparesis. Gastroenterology. 2003; 125:421-28.
    GES Product Family

    Enterra System

    The Enterra system delivers mild electrical pulses to the smooth muscles of the lower stomach. This stimulation helps control the chronic nausea and vomiting associated with gastroparesis.

    The Enterra system has the following components.

    • A small, battery-powered gastric neurostimulator implanted beneath the skin in the lower abdominal region.
    • Two intramuscular leads, implanted in the muscle wall of the stomach and connected to the neurostimulator.
    • A handheld, external programmer, used by the clinician to noninvasively adjust the settings of the neurostimulator for customized therapy.

    Product information

    About HDE

    The Medtronic gastric electrical stimulation device, the Enterra® Gastric Neurostimulator, received humanitarian device exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) in 2000. HDE status allows Medtronic, Inc. to provide the Enterra Therapy System for the treatment of chronic intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic origin.

    Institutional Review Board Approval

    A humanitarian use device must be implanted in a medical center whose institutional review board has approved use of the device. Your Medtronic representative can provide a product information packet for your review board submission. Contact your Medtronic representative.

    Frequently Asked Questions About Humanitarian Device Exemption

    Medtronic has compiled this information for your convenience only. The following questions and answers provide information about humanitarian use devices and describes how the U.S. Food and Drug Administration (FDA) approves them. For more information, please contact your local Medtronic Neuromodulation Health Economics Manager.


    What Is a Humanitarian Use Device (HUD)?

    A humanitarian use device (HUD) is a medical device intended to treat or diagnose a disease or condition that affects, or is manifest in, fewer than 4,000 individuals per year in the United States.


    What Is a Humanitarian Device Exemption (HDE)?

    A humanitarian device exemption (HDE) authorizes the marketing of a humanitarian use device. A humanitarian device exemption application is similar in form and content to a FDA premarket application (PMA), but exempt from the efficacy requirements of a PMA. A HDE is a determination that a HUD is safe and has probable benefit.


    How Is Marketing Approval Obtained?

    First, the medical device manufacturer requests a humanitarian use device (HUD) designation from the FDA Office of Orphan Product Development (OOPD). Once the humanitarian use device designation is granted, the manufacturer applies for a humanitarian device exemption from the FDA Office of Device Evaluation (ODE).


    What Does the FDA Look for in a Humanitarian Device Exemption Application?

    The FDA determines whether the probable benefit of the proposed therapy outweighs the risk of injury or further illness to the patient.


    How Does the FDA Safeguard Patient Safety Once a Humanitarian Device Exemption Is Granted?

    The FDA requires that a humanitarian use device be used only in medical centers in which the center’s institutional review board (IRB) has approved use of the device. IRB approval for individual patients is not required.


    Does the FDA Place Restrictions on the Sale of a Humanitarian Use Device?

    In 2012 Congress passed legislation that included humanitarian use device reforms. Now a device manufacturer with an HDE approved before or after 2007 may seek FDA determination that the HDE qualifies as a pediatric or adult HDE that is allowed to profit, and establishes an Annual Distribution Number for the HDE which is the number of devices reasonably needed to treat, diagnose, or cure 4,000 individuals per year in the United States.

    The FDA can inspect HDE sales records and the device manufacturer must report to FDA if sales exceed the Annual Distribution Number. Pediatric HDEs eligible for profit are subject to additional pediatric safety reviews by FDA to review medical Device Reports and to determine if the HDE remains appropriate for pediatric patients.


    Is a Humanitarian Use Device Subject to the Same Regulations as Other Market-Approved Medical Devices?

    Yes. The manufacturer of a humanitarian use device is required to comply with Quality Systems Regulations (QSR), unless an exemption has been granted. Patient informed consent for treating or diagnosing a patient with a HUD is not required by federal regulations, but may be required by the medical center’s IRB.

    In addition to following Medical Device Reporting requirements, the FDA requires that manufacturers report any adverse events not described in the approved labeling.

    For reference and additional information, call Center for Devices and Radiological
    Health (CDRH) Facts-On-Demand at (800) 889-0381.

    Humanitarian Device: The effectiveness of this device for this use has not been demonstrated. Learn more about HDE.

    United States