Important update regarding Enterra® Therapy availability
We want to share an important update regarding Enterra Therapy.
The U.S. Food and Drug Administration (FDA) has informed Enterra Medical that Enterra Ascent™ may be made available to patients while the FDA review process continues.
Enterra Ascent™, a gastric electrical stimulation (GES) system made by Enterra Medical, has not been approved by the FDA. Because of the shortage of the Enterra® II device, the FDA has notified Enterra Medical that Enterra Ascent may be distributed under an FDA enforcement policy for medical device supply shortages while the FDA’s review of the Enterra Ascent submission continues. This does not mean that FDA has approved Enterra Ascent or made any determination about its safety or probable benefit. Enterra Medical expects initial shipments to healthcare providers to begin in mid-November 2026.
Enterra Ascent is intended to provide the same therapy as the Enterra II System, which is no longer available, but it has design changes that the FDA has not yet fully reviewed or approved. Your doctor will decide whether Enterra Ascent is right for you.
Is Enterra Therapy available again?
Yes.
Enterra Therapy is expected to become available again through Enterra Ascent, with initial shipments to healthcare providers expected to begin in mid-November 2026.
Supply will be very limited at first. Enterra Medical has begun manufacturing Enterra Ascent and is working to make more devices available as quickly as possible. Because many patients are already waiting for treatment, demand is expected to far exceed available supply early on.
Supply is expected to improve as production increases, but demand is expected to remain higher than available supply for some time. Timing will depend on several factors, including manufacturing output and demand. Enterra Medical cannot guarantee when a device will be available for any individual patient.
Why might I still have to wait for treatment?
Because device availability is limited, treatment timing will vary based on several factors, including:
- Your individual medical needs
- Scheduling at your healthcare provider or hospital
- Product availability
- Whether your treatment center is currently able to offer Enterra Ascent
Your doctor will decide, based on your clinical circumstances, whether Enterra Ascent is right for you and when treatment may be scheduled. Your doctor will also discuss the possible risks and benefits of Enterra Ascent, as well as other treatment options, including waiting for an approved device. There is limited experience with use of the Enterra Ascent in humans. Although your doctor will discuss the potential risks of the device with you, there may be other risks, side effects, or complications that are currently unknown or unexpected. Your decision whether to receive Enterra Ascent is voluntary.
What should I do if I am waiting for or considering Enterra Therapy?
We encourage you to stay in close contact with your healthcare provider.
Your healthcare provider can:
- Discuss whether Enterra Therapy remains appropriate for your situation
- Provide updates regarding treatment availability
- Help determine the next steps in your care
- Answer questions about procedure scheduling
If you were previously scheduled for a procedure that was delayed, please contact your healthcare provider for the most current information regarding your treatment plan.
Frequently Asked Questions
What is Enterra Ascent?
Enterra Ascent is a gastric electrical stimulation system made by Enterra Medical for use with Enterra Therapy. It is intended to provide the same therapy as the Enterra II system, which is no longer available, but it has design changes that the FDA has not yet fully reviewed.
Is Enterra Ascent FDA approved?
No. Enterra Ascent has not been approved by the FDA. The FDA has notified Enterra Medical that Enterra Ascent may be distributed under an FDA enforcement policy for medical device supply shortages while the FDA’s review continues.
This does not mean that FDA has approved Enterra Ascent or made any determination about its safety or probable benefit. Enterra Medical continues to work with the FDA toward approval.
Is Enterra Ascent safe?
Patient safety remains Enterra Medical’s highest priority.
Enterra Ascent has not been approved by the FDA, and distribution under the FDA enforcement policy does not mean that the FDA has made any determination about its safety or probable benefit. Enterra Ascent is intended to provide the same therapy as Enterra II, but it includes design changes that the FDA has not yet fully reviewed. Enterra Medical continues to work with the FDA as its review continues.
Your doctor will discuss the possible risks and benefits of Enterra Ascent, as well as other treatment options, including waiting for an approved device. There is limited experience with use of Enterra Ascent in humans. Although your doctor will discuss the potential risks of the device with you, there may be other risks, side effects, or complications that are currently unknown or unexpected.
Is there something wrong with Enterra Therapy or the device?
The recent interruption in availability was not caused by a safety issue with Enterra II. It was caused by a shortage of electronic components needed to manufacture Enterra II neurostimulators. Enterra Ascent is a different device that has not been approved by the FDA, which means that the FDA has not yet made any determination about its safety or probable benefit. Your doctor can discuss its possible risks and benefits with you.
Will more devices become available?
Yes. Enterra Medical is increasing manufacturing and expects device availability to improve over the coming weeks and months. Timing depends on factors such as manufacturing output and demand, and Enterra Medical cannot guarantee when a device will be available for any individual patient.
Stay updated
The information on this page is current as of the date posted and may change. We will provide updates as product availability and regulatory status change.
If you would like to receive updates regarding Enterra Therapy availability, please sign up below.
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Questions about your care?
Questions about whether Enterra Ascent is right for you, your treatment plan, procedure scheduling, or medical care should be directed to your doctor.
Questions about Enterra Therapy?
Contact Enterra Medical’s 24-hour support line at 1-855-768-3772
A message to patients and caregivers
We recognize that many patients and families have been waiting for treatment and may be eager for updates. We appreciate your patience and understanding during this period.
Enterra Medical remains committed to supporting patients, caregivers, and healthcare providers, including device programming and follow-up care for patients who receive Enterra Ascent. We are working hard to increase production and support healthcare providers.
For informational purposes only. Patients should consult their healthcare provider regarding medical decisions.
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?