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Challenge of gastroparesis

Gastroparesis is more than a motility issue

Current treatments focused on addressing motility often fail, leaving gastroparesis patients without options focused on relieving nausea and vomiting—the most distressing symptoms of gastroparesis.2

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).

In 2021, a 12-year NIH study of patients with upper GI symptoms found gastric emptying results are variable and do not correlate with clinical symptoms.3

Gastroparesis is a quality of life issue

  1. Janssen P, Harris MS, Jones M, et al. The relation between symptom improvement and gastric emptying in the treatment of diabetic
    and idiopathic gastroparesis. The American journal of gastroenterology. 2013;108(9):1382-1391. doi:10.1038/ajg.2013.118.
  2. Yu D, Ramsey FV, Norton WF, et al. The Burdens, Concerns, and Quality of Life of Patients with Gastroparesis. Dig Dis Sci .
    2017;62(4):879-893. doi:10.1007/s10620 017 4456-7.
  3. Pasricha, J. et al. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features. Gastroenterology. 2021 May; 160(6):2006-2017. doi: 10.1053/j.gastro.2021.01.230.
  4. Lacy BE, Crowell MD, Mathis C, Bauer D, Heinberg LJ. Gastroparesis: Quality of Life and Health Care Utilization. J Clin Gastroenterol.
    2018;52(1):20-244.doi:10.1097/MCG.0000000000000728.

MKT-D-0006, Rev M

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?