RefluxStop™

RefluxStop™️ hinders acid reflux without compressing the food passageway

Implantica

Gastroesophageal reflux disease

Gastroesophageal reflux disease (GERD or acid reflux) is a disease caused by the reflux of gastric acid into the esophagus.

Source: 1.The Karolinska Institute 2017; Cancer Research UK 2014; Lagergren et al. 19992. Modiano, Gerson 2007; Cossentino, Wong 2003

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Chronic acid reflux can cause serious damage to the esophagus such as inflammation and ulceration, which can lead to a precancerous condition called Barrett‘s esophagus1, affecting 10-20% of daily sufferers2.

Between the esophagus and the stomach is a closing ring muscle, the Lower Esophageal Sphincter (LES). It allows food to pass into the stomach but prevents stomach fluid from flowing back into the esophagus. The esophageal sphincter functions properly when it remains in its natural position in the abdomen below the diaphragm (see Fig. 1).

How acid reflux developsWhen the esophageal sphincter istemporarily or permanently in thechest and thus above the diaphragm, itmay not function properly, and stomachfluid can travel backwards into theesophagus causing acid reflux (see Fig. 2). While breathing, pressure variation isproduced in the chest hindering the LESfrom functioning properly. The pressurein the chest is lower than the pressure in the abdomen and therefore does notsupport the closing of the LES, resulting in acid reflux.

Figure 1

Figure 2

Source: 1. Raghunath AS et al. 20092. W. Gomm 2016; Moreira Faulhaber 2010; M. E. Grams et al. 2016; Rosch P 2010; Cheung K et al. 2017; Washio et al. 2016

Typical symptoms, discomforts and syndromes associated with acid reflux● Heartburn● Barrett’s esophagus (precancerous changes)● Regurgitation (reflux of gastric contents / fluids)● Pain in the upper abdomen● Bloating / gas bloat syndrome● Difficulties to swallow● Lump in throat● Chronic cough● Hoarseness● Tooth damage

Methods of treatment● Change eating habits● Drug therapy to alleviate the symptoms● Surgical treatment

DrugsDrugs are the standard therapy, particularlyat initial diagnosis. The production of acid islimited by proton pump inhibitors (PPIs), the most commonly used drug. The advantagewith this treatment method is that no surgeryis needed. The disadvantage, however, is thatreflux is not prevented and only the symptomsare alleviated due to lower acidity in the regurgitating stomach fluid. Furthermore, thesymptoms often do not completely disappear1

and continue to restrict the patient’s life.Lifelong drug therapy can lead to complicationsand unwanted side effects.2

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Source:1. Modiano, Gerson 2007; Cossentino, Wong 2003;2. The Karolinska Institute 2017; Brusselaers et al. 2018

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Cancer risk and drugsMost alarmingly, acid reflux is associated with precancerous changes in the lower esophagus (Barrett’s esophagus), which occurs in 10-20% of daily sufferers1 compared to 1-2% of the global population1.There is no proof that cancer risk is prevented by drug therapy2, which may be one of the major reasons to choose a surgical treatment.

Surgical treatmentThe fundoplication procedure hasbeen the standard acid reflux operation since the 1950s, although side effects are common. In this procedure, the upper part of the stomach is wrapped around the esophagus.These and other restric-tions or constrictions of the food passageway may lead to swallowing problems and other complications. Other operations such as radio- frequency treatments or other endoscopic procedures are only rarely used.

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RefluxStop™️ helps to restore the natural anatomy

● RefluxStop™ is an implantable medical device which ensuresthe natural function of the esophageal sphincter withoutcompressing the food passageway.

● The esophageal sphincter functions normally because RefluxStop™prevents it from gliding up from the abdomen into the chest.

RefluxStopTM maintains the esophageal sphincter in itsappropriate natural position

If the esophageal sphincter is temporarily or permanently above the diaphragm, it normally does not function correctly.

RefluxStop™ restores the naturalanatomy by keeping the esophagealsphincter permanently in theabdomen, below the diaphragm,acting as a mechanical stop. It isnot necessary to wrap, constrict or electronically stimulate theesophageal sphincter in order toprevent reflux as this could causeunwanted side-effects.

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RefluxStop™️ – safe and effective

The implant consists of 5 parts for optimal flexibility and maximum safety.

CE marked medical device

Clinical investigation successful

Approximate size and weight:

21.5 x 21.5 mm, 9 grams

Medical grade silicone

● Safe material with highbiological compatibility

● Decades of clinical experiencedemonstrate the safety ofmedical grade silicone in thegastrointestinal region

● Contains barium sulphateto make the implant visibleon x-rays

● Flexible rounded material● Without metal or

electronic components

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RefluxStop™️ – the surgery explained

● The surgery is performed as a minimally invasive procedure(keyhole surgery).

● The surgery typically lasts about an hour on average and isperformed under general anesthesia.

The procedureRepair of hiatal hernia, including repositioning the esophageal sphincter back into the abdomen and reducing the size of the hole in the diaphragm.Then placement of the Reflux-StopTM device as shown.

The implant consists of 5 parts for optimal flexibility and maximum safety. Result

RefluxStop™ now prevents the sphincter from gliding up into the chest, preventing acid re-flux by maintaining the natural anatomy. The food passageway remains unaffected.

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RefluxStop™️ – positive treatment & CE clinical trial results

Quality of life improved by 91% * pH value improved by 95%*

● RefluxStop™ does not cause swallowing problems.● Swallowing problems before surgery improved or disappeared

in all patients with the RefluxStop™ procedure.

Successful discontinuation of PPI medication*

*Multicenter Study Clinical Investigation RXI 001

30

Before Surgery With RefluxStop TM

6-8 month after surgery

20

10

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2.6

28.8

Before Surgery With RefluxStopTM

6-8 month after surgery

20

10

0

0.82

16.35

50

Before Surgery (n = 50) 6 weeks (n = 50) 3 months (n = 47) 6 months (n = 47)

45

40

35

30

25

20

15

10

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Source: 1.The Karolinska Institute 2017; Brusselaers et al. 2018

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Who can benefit from surgery with RefluxStopTM?

Patients suffering from acid reflux● who have concerns about the long-term side effects

of drugs (PPIs)● whose symptoms are not fully alleviated by medication,

e.g. heartburn● who want to reduce the risk of precancerous changes

not prevented by drug therapy1

● who suffer from chronic hoarseness and/or tooth damagedue to acid reflux

● who are subject to restrictions in everyday life and workdue to acid reflux

● whose quality of life is impaired● who have not benefitted from other anti-reflux surgical

procedures

Patients will undergo examinations such as esophageal 24-hour pH monitoring prior to surgery.

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RefluxStop™️ – frequently asked questions

What could I expect after the procedure?Acid reflux is expected to disappear shortly after surgery.

How fast am I back on my feet?Depending on local practice, patients can usually go home within a couple of days after surgery. After a week you should normally have completely recovered.

When can I eat normally again?The first day after surgery you will usually follow a liquiddiet and thereafter you can start to eat normally again.

Will I have difficulties swallowing?The food passageway is not restricted by the surgery with RefluxStop™and therefore swallowing is unimpeded.If you experienced swallowing problems before the surgery, there is a high likelihood that such swallowing problems will diminish or disappear,according to the experience of the RefluxStopTM clinical trial.

Will I have problems vomiting?The ability to vomit is normally not affected with RefluxStop™.

What are the results of the RefluxStopTM procedures?The results from the clinical trial are excellent, see page 8, but there always remains a small risk that an implant, or anysurgical procedure, might not or may only partially produce itsintended effect.

What is the likelihood that the implant will break in the long-term?RefluxStopTM is made of solid medical grade silicone and therefore has a high probability to last for life.

Can I feel the implant in my everyday life?No - you do not feel the implant.

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RefluxStop™️ – frequently asked questions

I’ve heard that other procedures could affect the ability to belch. Will RefluxStopTM also affect belching?Since RefluxStop™ does not constrict or confine the food passageway as opposed to other surgical methods, belching should normally be unaffected.

Once I have recovered from the surgery with RefluxStopTM, can I pursue my usual activities?There are no restrictions.

Do I have to show an implant passport at airport security? This is not needed. The implant is free of metal or electronic compo-nents - in contrast to, for example, cardiac pacemakers. Therefore, there should be no problems with air travel.

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