Patient selection & referral
Recommending the right patients for Enterra® Therapy
Enterra Therapy may be appropriate for patients meeting the following criteria:
- Have gastroparesis caused by diabetic or idiopathic origin
- Have difficulty managing nausea and vomiting symptoms, despite having tried first-line therapies of diet modification and medications
- Are 18-70 of age
Referring your gastroparesis patients to an implanting physician is a 3-step process.
Step 1
Educate
Educate your patients about gastroparesis symptoms, diagnosis, and treatment options.
Step 2
Recommend
If you think your patient may be a candidate for GES, complete the referral form and recommend that they consult with a specialist.
Step 3
Refer
Send your patients to a trained Enterra implanter or GI specialist.
Consider the patient care pathway and full patient selection criteria for your gastroparesis patients when recommending Enterra Therapy:
Care pathways are directed by the physician to reflect their current practice protocols.
Evaluation & Diagnosis
Medical History,
Physical Exam
Endoscopy
(no obstruction)
Gastric Emptying Test
(presence of delayed emptying)
First line therapies
Dietary Modifications
- Gastroparesis diet
- Glucose control
Pharmacologic Management
- Prokinetics
- Antiemetics
- Cessation of narcotics
Advanced Therapies
Gastric electrical
stimulation
Pyloric surgery
Other treatments
- feeding tubes
- gastrectomy
- and more
Patient selection criteria for gastric electrical stimulation
- Symptomatic gastroparesis ≥ 1 year
- Documented gastroparesis based on 4-hour solid-phase nuclear medicine emptying test
- 60% ≥ retention at 2 hours
- 10% ≥ retention at 4 hours
- Documented gastroparesis based on 4-hour solid-phase nuclear medicine emptying test
- Failed dietary modifications
- Refractory or intolerant antiemetic/prokinetic medications
- Viable surgical candidate
- Ages between 18-70 years
MKT-D-0006, Rev H
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?