Switzerland-based medtech firm Implantica says its RefluxStop device for treating acid reflux can ‘eliminate the need for proton-pump inhibitors (PPIs)’.
The company describes its lead product RefluxStop as ‘a passive CE-marked implant for prevention of gastroesophageal reflux’ that has the ‘potential to spur a paradigm shift in anti-reflux surgery as supported by clinical trial results’.
But what is it and how does it work?
RefluxStop is a silicon implant that is placed on the upper part of the stomach through laparoscopic (keyhole) surgery.
Once implanted, the device prevents reflux by making it difficult for the lower oesophageal sphincter (LES) to ‘enter the chest’.
What is the theory?
The fundoplication procedure is a popular surgical treatment for reflux, which involves wrapping the top part of the stomach around the LES.
But, according to Implantica, this procedure compresses the food passageway and leads to other issues, such as swallowing problems and the inability to burp and vomit.
The idea behind RefluxStop is that it tackles two ‘malfunctions’ that lead to reflux:
1. The first event includes an anatomical misalignment of the Angle of His (the acute angle created between the cardia at the entrance to the stomach, and the oesophagus) allowing for the reflux of stomach contents to enter the oesophagus. The Angle of His forms a valve preventing the reflux of duodenal bile, enzymes (pepsin) and stomach acid from entering the oesophagus.
2. The second event allows the lower oesophageal sphincter (LES) to enter the chest resulting in weaker pressure combined with abnormal breathing resulting in acid reflux.
The claim is that the surgical placement of RefluxStop will address these malfunctioning events.
Placing RefluxStop on the outside of the stomach top fundus wall achieves the reconstruction of the angle of the stomach top fundus wall and reinforcement of the top part of the stomach (fundus) by invaginating the device into the pocket created from the anterior wall of the fundus.
Is it safe?
According to Implantica, the device is safe as there have been no reports of serious adverse events associated with it. A CE mark approval was granted in August 2018, on the strength of a multi-centre clinical investigation in which the safety and effectiveness of the device in patients was demonstrated.
In January 2023, Implantica announced it had obtained renewed ISO 13485 Quality Management System (QMS) and Medical Device Single Audit Program (MDSAP) certificates from its notified body, BSI..
How effective is it?
Implantica has recently published the results of a three-year study with 47 patients and claims the results were ‘remarkable’. It reports that although all the patients were in need of regular daily use of PPIs (proton-pump inhibitors) before surgery, none needed the medication post-surgery.
The claim is that applying pressure on the food passageway reduces complications.
RefluxStop’s clinical investigation showed 95 per cent improvement in measured 24-hour pH in the lower oesophagus at six months after surgery.
According to the company, in 2022 the University of York’s Health Economics Consortium made an in-depth and robust health economic analysis of RefluxStop™ versus other treatment options. It claims the analysis “clearly showed improved incremental cost-effectiveness ratios (ICERs) of RefluxStop against other anti-reflux interventions” including Fundoplication, Magnetic augmentation device and PPI medical treatment.
What are the disadvantages to RefluxStop?
People may consider RefluxStop to be a very invasive technology.
Concerns could also arise regarding the lack of information on potential long-term issues caused by the implant and the small sample sizes used in the studies.
Some experts suggest that the misalignment of the Angle of the His is rare in adults and only normally seen in infancy.
We need further studies and follow-ups to be conducted.
Is it available yet?
RefluxStop is available in Italy, Spain, Switzerland, Germany as well as the UK.
In October 2022, Implantica implemented the RefluxStop procedure at Spire Manchester Hospital, which is also part of the Spire Healthcare Group, a network consisting of 39 hospitals and eight clinics across England, Wales, and Scotland.
Its investor update in November 2022 revealed that Implantica is working on approval in Canada, and it has started the process in Japan. However, the US its “number one target”.
Implantica is also currently preparing for premarket approval application for FDA (Food & Drug Administration) regulatory approval in the US.
Please note: This blog post is for information only and is not an endorsement or critique of the RefluxStop device. You should always consult your doctor prior to undertaking any treatment for reflux. The last update to this blog content took place in January 2023.
An early and objective diagnosis of reflux, such as Peptest provides, opens the door to lifestyle changes, and future treatment.
Peptest can also assess the success or failure of any reflux treatment after the treatment is administered.
Find out more about Peptest and order your Peptest home testing kit now.