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Clinical evidence

Designed to deliver durable relief from nausea & vomiting

A number of key clinical studies involving diabetic and idiopathic gastroparesis patients receiving Enterra® Therapy resulted in significant nausea and vomiting symptom improvements.

Additional clinical studies

Prospective

Effectiveness of gastric electrical stimulation in gastroparesis

(2019)

Abell et al.

Prospective

Surgical treatment for refractory gastroparesis: stimulator, pyloric surgery, or both?

(2020)

Zoll et al.

Prospective

Tailored approach to gastroparesis significantly improves symptoms

(2018)

Arthur et al.

Enterra Therapy supported by practice guidelines

AGA best practices review (2021)

“Enterra Therapy does improve refractory nausea and vomiting in some patients with gastroparesis and may improve glycemic control, nutritional status, and quality of life, while reducing hospitalizations and medication use.”5

ACG guidelines (2022)

“Gastric Electric Stimulation (GES) may be considered for control of GP symptoms as a Humanitarian Use Device (HUD).”6

  1. McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study. Clin Gastroenterol Hepatol. 2010;8(11):947-e116. doi:10.1016/j.cgh.2010.05.020.
  2. McCallum RW, Snape W, Brody F, Wo J, Parkman HP, Nowak T. Gastric electrical stimulation with Enterra therapy improves symptoms of idiopathic gastroparesis. Neurogastroenterol Motil (2013) 25, 815–e636.
  3. Ducrotte P, Coffin B, Bonaz B, et al. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020;158(3):506-514.e2. doi:10.1053/j.gastro.2019.10.018.
  4. Hedjoudje A, Huet E, Leroi AM, Desprez C, Melchior C, Gourcerol G. Efficacy of gastric electrical stimulation in intractable nausea and vomiting at 10 years: A retrospective analysis of prospectively collected data. Neurogastroenterol Motil. 2020;32(11):e13949. doi:10.1111/nmo.13949.
  5. Lacy BE, Tack J, Gyawali CP. AGA Clinical Practice Update on Management of Medically Refractory Gastroparesis: Expert Review [published online ahead of print, 2021 Oct 29]. Clin Gastroenterol Hepatol. 2021;S1542 3565(21)01151 4. doi:10.1016/j.cgh.2021.10.038.
  6. Camilleri, et al. ACG Clinical Guidelines: Gastroparesis. Am J Gastroenterol. 2022 Aug 1;117(8):1197-1220. doi: 10.14309/ajg.0000000000001874.

MKT-D-0006, Rev K

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?