Surgeries using RefluxStop restore the lower oesophageal valve to its natural position. Credit: chrisdorney/Shutterstock.

Medtech Implantica’s RefluxStop device for gastro-oesophageal reflux disease (GORD) has been rolled out at University Hospital Southampton.

The Swedish company’s device was first used in the National Health Service (NHS) in September of last year at St Mary’s Hospital, part of Imperial College Healthcare NHS trust.

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Until now, proton pump inhibitors (PPIs), a class of drugs that reduce the amount of stomach acid produced by the glands in the stomach lining, have been a common method in addressing GORD. However, according to Implantica CEO Peter Forsell, up to 40% of patients are not helped by PPIs. In addition, studies have shown that PPI use can increase the risk of gastric cancer.

Forsell states that in the US and Europe combined, around 48,000 people die from oesophageal cancer each year.

“This is a totally unacceptable situation for patients in this treatment field, and the main reason for this is that there is no existing good alternative to these drugs,” Forsell told Medical Device Network.

Previous implantable solutions to manage acid reflux work by closing up the stomach to limit the amount of gas that enters the oesophagus. However, putting pressure on the lower oesophagal sphincter (LES) can often result in further issues including difficulty in swallowing and patients experiencing gas bloating.

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“What we find with RefluxStop is that there is nothing wrong with this sphincter muscle (LES),” Forsell said. “The problem is its position. We place our device parallel to the food passageway, which remains unaffected.

“This approach means that we restore the normal anatomy, wherein the LES keeps its distance to the diaphragm placed in the abdomen, mitigating the risk of acid reflux and hiatal hernias by the way LES stays in position and avoids moving into the chest, with RefluxStop acting like a mechanical stop to control the LES’ position.

“The results so far have been outstanding, both in improving treatment effect and reducing side effects.”

For these reasons, Implantica anticipates that its RefluxStop solution may become the future standard of care for GORD.

In addition, research by the University of York’s Health Economic Consortium, which compared RefluxStop to the other available methods of treating GORD including PPI, found that it was the most cost-effective treatment type, compared with medical treatment with PPI and current surgical standards of care.

Implantica hopes to announce the rollout of RefluxStop to several more NHS trusts throughout 2024.

Eight Italian hospitals have begun offering the treatment so far in 2024, with six further hospitals to follow by the end of the year.

Six Spanish hospitals are also implanting the device, with at least six more anticipated to do the same by the end of 2024.