Implantica’s Solution to Acid Reflux, RefluxStop™
RefluxStop™ treats acid reflux without affecting the food passageway, a novel method that will possibly create a paradigm shift in acid reflux treatment. This ingenious device is a non-active implant and is placed on the upper part of the stomach through laparoscopic (key hole) surgery. CE mark approval was granted August 8, 2018, on the strength of a multi-center clinical investigation in which the safety and effectiveness of the device in patients was demonstrated.
RefluxStop™ treats acid reflux without affecting the food passageway, a novel method that possibly will create a paradigm shift in acid reflux treatment.
Acid reflux is the second largest treatment field in the world, with 400 million daily sufferers1. RefluxStop™ not only treats the symptoms of acid reflux but also eliminates the regurgitation of stomach fluid – unlike drug therapy. The clinical investigation supports that complication rates are reduced with RefluxStop™ compared to current surgical treatments.
The clinical investigation indicates reduced complication rates compared to current treatments.
Acid reflux sufferers consumed drugs for USD 24 billion in 20102. We expect the surgical treatment addressable market to grow substantially to reach a couple of million operations yearly3, and the clinical trial results support that RefluxStop™ has the potential to completely change the treatment of acid reflux.
We expect the addressable market to reach 2.4 million operations yearly3.
- 1Johnson 2009; Stuart 2005
- 2AstraZeneca 2010
- 3The Karolinska Institute Review Article, 2017, not yet published
Complication and Cancer risk with Acid Reflux
Acid reflux creates precancerous changes in the lower esophagus, called Barrett’s esophagus, by iterative damage caused by stomach fluid found in 10-15% of acid reflux patients4. For daily sufferers the incidence is even higher probably at 20%5. The most common treatment method, drug therapy, does not prevent acid reflux but only reduces the acidity in the regurgitating stomach fluid, and the majority of patients continue to experience heartburn now and then. 59% of drug users continue to intermittently have acid reflux6 and only 1 out of 9 become completely symptom free.6
Therefore, it’s logical that when performing a literature review one cannot find any proof that drug therapy reduces this cancer risk3. With up to 60 million people suffering from Barrett’s esophagus4 and an annual cancer risk of 0.6% per year7, this treatment field is in urgent need of a well-working surgical treatment.
The current standard of care surgical treatments of acid reflux often lead to complications, such as swallowing problems, because they encircle the food passageway. RefluxStop™ has a unique mechanism of action and does not affect the food passageway thereby reducing complications, as supported by the clinical investigation.
- 4Cossentino MJ, Wong RK. 2003. Barrett’s esophagus and risk of esophageal adenocarcinoma. Semin Gastrointest Dis.; Schlottmann F, Molena D, Patti MG. 2018. Gastroesophageal reflux and Barrett’s esophagus: a pathway to esophageal adenocarcinoma. Updates in Surgery
- 5Modiano N, Gerson L. 2007. Barrett’s esophagus: Incidence, etiology, pathophysiology, prevention and treatment. Therapeutics and Clinical Risk Management
- 6Raghunath AS, Hungin AP, Mason J, Jackson W. 2009. Symptoms in patients on long-term proton pump inhibitors: prevalence and predictors. Alimentary Pharmacology & Therapeutics
- 7Yousef F et al. 2008. The incidence of esophageal cancer and high-grade dysplasia in Barrett’s esophagus: a systematicc review and meta-analysis. Am. Jour. of Epedimiol.
Benefits of RefluxStop™
Treats GERD without affecting food passageway
RefluxStop™ successfully treats acid reflux without affecting the food passageway, thereby minimizing side effects. Standard of care fundoplication encircles and compresses the food passageway, leading to complications, such as pain when swallowing or the inability to belch or vomit.
Removes the need for drug therapy
In the clinical investigation, at 3 years after RefluxStop™ surgery all patients with evaluable data no longer took regular daily PPI drug therapy.
Successful clinical trial results
RefluxStop™ clinical investigation showed 95% improvement in measured 24 hour pH in the lower esophagus at 6 months after surgery.
In addition, a validated acid reflux questionnaire (GERD-HRQL) showed a 97.7% improvement in score from before surgery to 6-8 months after surgery.
Safety issues during the clinical trial
- No RefluxStop™ related adverse events/complications (ADEs or SADEs)
- No device deficiencies
- No device taken out
- No complications (AEs) leading to withdrawal from the CE-mark clinical trial
Acid reflux or gastroesophageal reflux disease (GERD) is the term describing a condition in which liquid, acid content of the stomach, regurgitates (or refluxes) up to the esophagus, the tube connecting the stomach with the throat. The condition is common and almost everyone experiences this from time to time. Acid reflux affects people of all ages and backgrounds. The condition turns into the chronic disease gastroesophageal reflux disease, commonly referred to as GERD, when the frequency of acid reflux is abnormal.
GERD is one of the most highly prevalent diseases in the world with 31% of people suffering on a weekly basis8 and around 375 million with daily problems9. GERD has a considerable financial impact on society10.
The most common symptom of GERD is heartburn, a burning pain from behind the sternum, the breastbone. Other symptoms in more advanced cases are chest pain, difficulty swallowing, pain when swallowing, coughing, wheezing and/or vomiting. Sleeping disorder often becomes part of these patients’ everyday life as lying down increases the risk of acids entering the esophagus. For all GERD patients, their quality of life is severely affected.
- 8Zebrowski & fox-tucker, 2006
- 9Johnson 2009; Stuart 2005
- 10Brook et al. 2007; El-Serag, 2007
The most common way to treat GERD is through pharmaceutical treatment. Proton pump inhibitors, PPI drugs, are proven to be the most efficient non-surgical treatment for GERD, even though they only treat the symptoms and not the cause – reflux with lower acidity is still present. Also 59% of the drug users experience heartburn now and then.11 This is probably the reason why the cancer risk with Barrett’s esophagus is not reduced by drug therapy.12
Since the 1950’s the standard surgical treatment of GERD has been the fundoplication procedure, even though side effects are common. This procedure is when the top part of the stomach is wrapped around the ring muscle closing between the stomach and esophagus, the lower esophageal sphincter (LES). Other surgeries, radiofrequency treatment, or several different endoscopic procedures have proven less effective and are not used much.
All of the fundoplication methods have one major drawback – they all compress the food passageway – thereby causing swallowing problems and the inability to belch and vomit. Implantica’s new device treats acid reflux without affecting the food passageway at all. The complications of existing surgical treatments are so frequent that only around 100’00013 operations are performed in the US and Europe p.a. – although the need easily could be seen as a multiple of tenfold.
The substantial size of this treatment field can be concluded from the annual drug consumption of USD 24 billion in 2010.14 Yet only 1 out of 9 drug consumers become completely symptom free, thus there is a large need for a complication-free surgical procedure.
- 11Raghunath AS, Hungin AP, Mason J, Jackson W 2009
- 12The Karolinska Institute Review Article, 2017, not yet published
- 13ISS, Integrated Scientific Services 2018
- 14AstraZeneca 2010