Products and Procedures
Gastric electrical stimulation may provide relief from chronic nausea and vomiting caused by gastroparesis of diabetic or idiopathic origin for drug-refractory patients.
Our gastric electrical stimulation system includes the following components:
Procedural content for gastric electrical stimulation includes:
Products for Gastric Electrical Stimulation
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Enterra NeurostimulatorModel 3116 |
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Product Details |
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Unipolar Intramuscular LeadModel 4351 |
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Product Details |
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N'Vision Clinician ProgrammerModel 8840 |
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Product Details |
Procedure Overview
Implant Procedure
The surgical procedure for the gastric neurostimulation system is performed under general anesthesia and takes 1 to 2 hours. Using laparotomy (abdominal incision) or laparoscopy (abdominal visualization via an endoscope), the stimulating electrode of each intramuscular lead is fixed to the muscle of the antrum (lower stomach).
The connector end of each lead is attached to the neurostimulator, which is then placed in a small pocket through an incision in the abdomen.
Product technical manuals must be reviewed for detailed step-by-step instructions on the implant procedure.
Implant Procedure Resources
Educational Brief on Enterra Implant Procedures
This brief provides important information for physicians who implant or monitor patients with the Enterra gastric neurostimulator.
HDE Informed Consent Template-English
HDE Informed Consent Template-Spanish
This optional tool can help you in preparing an informed consent document for your patients if your IRB requires it.
Suggested OR Supply Lists for Laparotomy
Suggested OR Supply Lists for Laparoscopy
These are examples of typical laparotomy and laparoscopic OR supply lists.
Device Tracking Registration Form
Print and fill out this form every time you implant an Enterra gastric neurostimulator. This information is used by the FDA. There is also a sample of a completed Device Tracking Registration Form.
Replacing the Neurostimulator
The battery life of the neurostimulator will vary depending on how strong the stimulation must be for managing the patient’s condition. The battery life is estimated to be from 5 to 10 years.
Procedure Videos
Medtronic offers the following procedure videos to qualified healthcare professionals. Please register or Log In to view these videos.
Laparoscopic Implant Procedure Videos
Chapter 1: Introduction
(1:55, 10 MB)Introduces the Medtronic Enterra® Therapy System for gastric electrical simulation (GES) to help control the chronic nausea and vomiting symptoms associated with gastroparesis.
Laparoscopic Implant Procedure Video by Chapter
Chapter 2: Prepare for Procedure
(1:53, 10 MB)Provides a suggested list of Medtronic, products and supplies required to implant the Enterra Therapy System for GES.
Chapter 3: Surgical Preparation
(2:00, 10 MB)Gives an overview of pre-surgery procedures including setting up programmer, administering IV antibiotics, and identifying laparoscopic ports and the neurostimulator pocket site.
Chapter 4: Implantation of Leads/Tunneling
(5:21, 27 MB)Discusses how to implant the lead electrodes into the muscle layer of the stomach and verify placement with endoscopy to ensure optimal stimulation.
Chapter 5: Pocket Creation
(2:32, 13 MB)Explains how to form the pocket, prepare the neurostimulator for placement, and ensure that all connections are secure.
Chapter 6: First System Check
(2:17, 11 MB)Introduces steps for conducting the first system check prior to implant to ensure the electrode impedance values are at an acceptable range.
Chapter 7: Implanting the Stimulator
(1:32, 8 MB)Describes how to place the neurostimulator in the pocket and wrap wires to minimize damage or kinking during closure.
Chapter 8: Second System Check
(0:55, 5 MB)Demonstrates how to conduct a second check of the system to ensure it is working properly once the neurostimulator is placed in the open pocket.
Chapter 9: Concluding the Procedure
(1:45, 9 MB)Describes the final steps of the procedure including anchoring the neurostimulator, closing the surgical wound, checking the system, and obtaining X-rays to verify original placement.
Chapter 10: Post-Operative Considerations
(1:38, 9 MB)Discusses post-op treatment and explains necessary Medtronic registration forms to ensure patient receives important follow-up information.
Laparotomy Implant Procedure Videos
Chapter 1: Introduction
(2:01, 10 MB)Introduces the Medtronic Enterra Therapy System for gastric electrical simulation (GES) to help control the chronic nausea and vomiting symptoms associated with gastroparesis.
Laparotomy Implant Procedure Video by Chapter
Chapter 2: Prepare for Procedure
(1:51, 9 MB)Provides a suggested list of Medtronic products and supplies required to implant the Enterra Therapy System for GES.
Chapter 3: Surgical Preparation
(1:57, 10 MB)Gives an overview of pre-surgery procedures including setting up programmer, administering IV antibiotics, and identifying laparoscopic ports and the neurostimulator pocket site.
Chapter 4: Implantation of Leads
(4:30, 22 MB)Discusses how to properly implant the lead electrodes into the muscle layer of the stomach and verify placement with endoscopy to ensure optimal stimulation.
Chapter 5: Pocket Creation/Tunneling
(2:48, 14 MB)Explains how to form the pocket, prepare the neurostimulator for placement, and ensure that all connections are secure.
Chapter 6: First System Check
(1:58, 10 MB)Introduces steps for conducting the first system check prior to implant to ensure the electrode impedance range is at an acceptable range.
Chapter 7: Implanting the Stimulator
(1:32, 8 MB)Describes how to place the neurostimulator in the pocket and wrap wires to minimize damage or kinking during closure..
Chapter 8: Second System Check
(0:55, 5 MB)Demonstrates how to conduct a second check of the system to ensure it is working properly once the neurostimulator is placed in the open pocket.
Chapter 9: Concluding the Procedure
(1:44, 9 MB)Describes the final steps of the procedure including anchoring the neurostimulator, closing the surgical wound, checking the system, and obtaining X-rays to verify original placement.
Chapter 10: Post-Operative Considerations
(1:38, 8 MB)Discusses post-op treatment and explains necessary Medtronic registration forms to ensure patient receives important follow-up information.
Tips for Success Videos
For first time implanters, do you recommend a laparotomy or laparoscopic procedure?
(:51, 5 MB)Discusses reasons why first-time implanters may want to consider the open implant procedure for the Enterra Therapy System.
Tips for Success Video by Chapter
How large is the neurostimulator? How large should the incision be?
(1:04, 6 MB)Describes the neurostimulator dimensions, recommended incision size, and appropriate placement.
If a patient has a jejunal feeding tube (J tube), are there any modifications to the implant?
(:43, 4 MB)Recommends how to position the neurostimulator for patients with a jejunal feeding tube (J tube).
What causes impedance to be too low?
(:47, 4 MB)Describes how low impedance can be attributed to either a short in the lead or the electrode spacing being too close.
What causes impedance to be too high?
(:56, 5 MB)Describes how high impedance can be caused by neurostimulator set screws either too tight or not tight enough, fractured lead wire, electrode spacing, or other reasons.
What causes impedance to be unacceptable when I insert the lead into the neurostimulator and do my system check?
(1:29, 8 MB)Discusses how to trouble shoot the ‘impedance out of range’ error message.
What if the impedance reading is still outside of the acceptable range?
(1:31, 8 MB)Explains how to perform an automated impedance check and adjust the voltage.
Why should I anchor the neurostimulator to the fascia in the pocket?
(1:09, 6 MB)Discusses how neurostimulators can migrate if they are not properly anchored.
If the neurostimulator is explanted, what happens to the leads?
(1:12, 7 MB)Describes how to handle leads if a neurostimulator is removed for a reason other than infection or for the patient to have an MRI.
What should I do if the electrode is penetrating the stomach mucosa?
(1:07, 6 MB)Reviews the process for using endoscopy to verify placement of electrodes during implant.
Humanitarian Device: The effectiveness of this device for this use has not been demonstrated. Learn more about HDE.