About EnterraTM Therapy
A different approach to managing gastropararesis
Gastric electrical stimulation (GES) with Enterra Therapy enables you to offer your diabetic and idiopathic gastroparesis patients an advanced therapy option in their journey to find relief from nausea and vomiting.
The Enterra Therapy difference
Over 15,000 gastroparesis patients have received Enterra Therapy to treat their nausea and vomiting symptoms.
Minimally invasive
Targets nausea & vomiting
Adjustable
Reversible
How Enterra Therapy works
Enterra Therapy stimulates the nerves and smooth muscles of the stomach by delivering mild electrical pulses, thereby reducing nausea and vomiting symptoms associated with diabetic and idiopathic gastroparesis.
Unlike other surgical options, therapy with GES is reversible and preserves the patient’s innate anatomy. Using the external clinician programmer, therapy can be turned on or off at any time without surgery. The device can also be removed from the patient’s body.
Neurostimulator
A small, battery-powered gastric neurostimulator is implanted beneath the skin in the lower abdominal region.
Leads
Leads deliver mild, controlled electrical pulses to the antrum portion of the stomach muscle wall.
Programmer
The system is programmed to optimize therapy for the individual patient.
The exact mechanism of action of GES is unknown, but research is beginning to show that GES may impact the afferent (sensory) and efferent (motor) pathways between the stomach and the central nervous system, the cells types found in the circular muscle (ICC-CM), and myoneural connections—allowing for the alleviation of symptoms.1
Procedure overview
Electrodes are implanted in the stomach wall
Neurostimulator is implanted in subcutaneous abdominal pocket
Patient recovery is typically 1-2 days
Therapy is adjusted non-invasively
Enterra Therapy is most commonly implanted via laparoscopy or robotic surgical procedure. During the 1-2 hour procedure, the electrodes are placed 10 cm from the pylorus along the stomach’s greater curve, one cm apart, parallel from one another, and secured to the serosal surface. The neurostimulator is placed in subcutaneous tissue, typically in the abdomen.
While some patients leave same-day, a 1-2 day hospital stay is typical.
Post-procedure, Enterra Therapy can be adjusted non-invasively without surgery via the external programming device to optimize therapy for each patient.
Indication
Enterra Therapy 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.
FDA-approved as humanitarian device
GES with Enterra Therapy has been FDA approved as a humanitarian device since 1999.
A humanitarian use device is a medical device intended to treat or diagnose a disease or condition that affects, or is manifested in, fewer than 8,000 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.
Manuals and technical guides
Access prescriber, implant, MRI, and other manuals on the manual library.
MKT-D-0006, Rev F
IMPORTANT SAFETY INFORMATION
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
HUMANITARIAN DEVICE
Authorized by Federal law 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. The effectiveness of this device for this use has not been demonstrated. What does this mean?