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Enterra Ascent® has not been approved by the U.S. Food and Drug Administration (FDA). FDA has notified Enterra Medical that Enterra Ascent® and Enterra Entrust® may be distributed for implant under an FDA enforcement policy.

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Magnetic Resonance Imaging (MRI)

The Enterra Ascent® and Enterra® II Systems are MR Conditional. This means that patients with the the Enterra Ascent and Enterra II gastric electrical systems can safely have MRI examinations of some body parts under certain conditions. The conditions for MRI scans will vary with the type of MRI coil. For MRI using detachable head, upper extremity, or lower extremity RF transmit/receive volume coils, make sure that the neurostimulator stimulation is turned OFF prior to MRI. After scan is completed, turn stimulation back on using the clinician programmer.

Always obtain the latest MRI guidelines. Go to https://www.enterramedical.com/hcp/manual-library/.

MR conditional sign

Clinician Programmer (Enterra Entrust® 40100) on/off instructions

Instructions for turning a patient’s neurostimulator on or off with the 40100 clinician programmer, plus MRI impedance check and telemetry troubleshooting.
MKT-PM-04442, Rev B

Clinician Programmer (N’Vision® 8840) on/off instructions

Instructions for turning a patient’s neurostimulator on or off with the 8840 clinician programmer, plus MRI impedance check and telemetry troubleshooting.
MKT-PM-00638, Rev D

Need help?
Contact Enterra Medical

  • Technical support
  • Device-related questions
  • Patient identification card updates
  • Finding an Enterra provider
  • MRI-related questions
Call 1-855-768-3772

Questions about your Enterra device?

For technical support, device-related questions, or help finding an Enterra provider, call Enterra Medical at 1-855-768-3772.

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.

Regulatory statement

Enterra Ascent® has not been approved by the U.S. Food and Drug Administration (FDA). FDA has notified Enterra Medical that Enterra Ascent® and Enterra Entrust® may be distributed for implant under an FDA enforcement policy.

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?