NOTE: EndoStim has ceased operation due to lack of funding.
Once you’ve had a positive diagnosis of gastro-oesophageal reflux disease (GORD) or laryngopharyngeal reflux (LPR), the next step is to find the best treatment for you.
These can include reflux medication, changes in diet and lifestyle tweaks. If your reflux symptoms continue to persist, the next approach might be to consider surgery to the lower oesophageal sphincter (LOS).
During normal digestion, the LOS stomach valve opens to allow food to pass into the stomach and closes to prevent food and acidic stomach juices from flowing back into the oesophagus. Reflux often results from a weak or damaged LOS which relaxes inappropriately and allows stomach contents to reflux into the oesophagus.
What is EndoStim?
EndoStim involves applying electronic current to the nerves around the LOS to increase its effectiveness – a technology known as neurostimulation.
The EndoStim system consists of a bipolar lead (electrical wire) that delivers low energy electrical pulses to the lower oesophageal sphincter and an Implantable Pulse Generator (IPG) – a small device similar to a pacemaker – which is wirelessly programmed and can be adjusted to suit each patient’s needs.
By stimulating the LOS valve, it is expected to stay closed to prevent reflux and open to allow for food and drink to pass into the stomach.
How is EndoStim carried out?
The device is implanted through a laparoscopic procedure – a surgical technique that allows a surgeon to access the inside of the abdomen without having to make large incisions in the skin.
The implantation procedure takes around 40 minutes to one hour.
After the procedure, the EndoStim device is programmed wirelessly by a doctor.
How effective is EndoStim?
According to the manufacturer, long-term clinical results of EndoStim patients treated for up to four years shows that electrical stimulation of the LOS is safe and effective in controlling GERD symptoms and improving patient quality of life in most patients.
Researchers have described it as a promising intervention for reflux disease, with a satisfactory safety profile and is therapy that significantly improves both heartburn and regurgitation. Patients have not reported gastrointestinal side effects or new-onset dysphagia, bloating, inability to belch, or diarrhoea associated with LES stimulation effects.
In a 2013 study, researchers concluded that during the long term follow-up of 12 months, electrical stimulation therapy was safe and effective for the treatment of reflux. It found a “significant and sustained improvement in symptoms, reduction in oesophageal acid exposure with elimination of daily PPI usage and no stimulation-related adverse.”
At a presentation at Digestive Disease Week 2016, an annual gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, it was reported that 1-year results show EndoStim significantly improved oesophageal acid exposure, GERD symptoms, PPI use and quality of life in patients with GORD partially responsive to PPIs.
Are there any issues or disadvantages to EndoStim?
All clinical data related to EndoStim has so far been derived from open label trials and commercial registries so lack data from control groups. (You can find clinical data on the EndoStim website).
In a study published online in 2016, it was reported that in a study of 25 implanted patients “no serious implantation or stimulation-related AEs or sensations were reported”, however 15 patients reported adverse effects during the following 12 months – mostly related to postoperative symptoms.
EndoStim therapy is currently not approved by the US Food and Drug Administration. It is, however, CE Marked for patients with gastro-oesophageal reflux disease with symptom duration of six months or longer.
Where can I have EndoStim therapy?
Vist your local EndoStim website to find treatment centres near you. In the UK, it is currently available at North Tyneside Hospital and Spire Leicester Hospital.
Have you had EndoStim therapy? Let us know your experience.