The Enterra® Therapy difference
A different approach to managing gastroparesis
Enterra® Therapy is the first and only device designed to reduce the nausea and vomiting associated with diabetic or idiopathic gastroparesis through gastric electrical stimulation (GES).
Implanted in over 20,000 patients, it is an advanced treatment option for patients with gastroparesis seeking relief from their most troublesome symptoms.
Targets nausea
& vomiting
Adjustable
Reversible
Targeted neurostimulation for nausea and vomiting relief
GES delivers electrical pulses to the nerves of the stomach wall to modulate gastric physiology and neural pathways involved in relieving nausea and vomiting.
Central Nervous System Pathways
Modulates brain pathways involved in nausea perception and visceral sensation.
Vagus Nerve Pathways
Stimulates afferent and efferent vagal pathways that support
autonomic balance and anti-inflammatory signaling.
Stomach Pathways
Supports gastric accommodation and improves gastric rhythm and contractility.
Procedure overview
Electrodes are implanted in the stomach wall
Enterra Therapy implant procedure typically takes 1-2 hours in a minimally-invasive laparoscopic or robotic surgical procedure, where the leads are placed on the serosal surface of the stomach’s greater curvature.
Neurostimulator is implanted in subcutaneous abdominal pocket
The neurostimulator is placed in subcutaneous tissue, typically in the abdomen.
Patient recovery is typically 1-2 days
While some patients leave same-day, a 1-2 day hospital stay is typical.
Therapy is adjusted non-invasively
Post-procedure, Enterra Therapy can be adjusted for symptom control via a programmer in an outpatient clinic.
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.
- Lacy BE, Tack J Gyawali CP, AGA Clinical Practice Updated on Management of Medicall Refractory Gastroparesis: Expert Review [published online ahead of print, 2021 Oct29] Clin Gastroenterol Hepatol. 2021;S1542-3565(21)011151-4.
doi:10.1016/j.cgh.2021.10.038.
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?