Implantica’s Solution to Acid Reflux, IM 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 375 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 due to the lack of viable long-term alternatives. We expect that the surgical treatment addressable market, once a viable treatment is available, 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.
- 1Stuart 2005
- 2AstraZeneca 2010
- 3The Karolinska Institute Review Article, not yet published
IM RefluxStop™ Design Thesis
- RefluxStop™ device hinders the reflux process – which occurs due to anatomical misalignment associated with suboptimal belch-like fundus contractions also including fluid, in combination with relaxation of the sphincter.
- RefluxStop™ device also acts as a mechanical stop, preventing the LES from moving into the thorax. Due to the pressure in the abdomen, the lower esophageal sphincter (LES) thereby can function normally.
The device works with a proven concept to prevent the closing sphincter from gliding up into the thorax through the opening in the diaphragm breathing muscle. When this happens, the sphincter muscle enters the chest, and while breathing, it does not have enough power to close.
As per the design thesis’ double mechanism, RefluxStop™ device is intended to treat acid reflux without affecting the food passageway, including hindering the LES from entering the thorax.
RefluxStop™ surgical procedure named the Forsell procedure after the inventor involves a reconstruction of the angle of His, a small left side adherence of the stomach to the esophagus, in broader terms also a fundoplication. RefluxStop™ device is invaginated in the fundus wall and thus reinforces the created cuff.
RefluxStop™ Operating Technique
With RefluxStop™ device enclosed in the fundoplication cuff it becomes thicker/deeper, allowing the cuff to be created with less circumferential distribution, thereby reducing side effects related to the food passageway and at the same time treating GERD more efficiently.
Placing RefluxStop™ at fundus
Removal of tool
RefluxStop™ Clinical Investigation
RefluxStop™ obtained CE mark certification on August 8, 2018. The approval enables Implantica to market and sell RefluxStop™ in member countries of the European Economic Area and Switzerland. Implantica, under confidentiality, informs about the clinical investigation month 6 results and the intended use of RefluxStop™.
24-hour pH monitoring showed a 95% improvement after RefluxStop™ surgery, with the percentage of overall time with pH less than 4 substantially reduced to 0.8% at month 6, an excellent result. As soon as the results are published, they will be disclosed in more detail.
Using a validated questionnaire, GERD symptoms in total GERD-HRQL score were assessed before and 6 months after RefluxStop™ surgery.
Results at month 6-8 showed an average improvement of 91% in the total GERD-HRQL score with 97.9% having > 50% improvement (p-value<0.001). The total score dropped to 2.6 at month 6-8. One patient experienced less improvement because the device was placed too low at surgery.
No safety concerns were associated with the RefluxStop™ device at month 6. There were no deaths, no device deficiencies, device related complications (no ADEs, no SADEs), no device explantations and no complications (AEs) leading to withdrawal.
In comparison to a literature review and meta-analysis on Nissen fundoplication performed by the Karolinska Institute (978 articles reviewed – 50 randomised articles selected), the results of the RefluxStop™ clinical investigation show (95% confidence intervals):
- Heartburn: 60% symptom reduction
- Dysphagia: 70% symptom reduction
- Odynophagia: 100% symptom reduction
At month 6 after surgery all patients with evaluable data stopped taking PPIs.4 As soon as the results are published, they will be disclosed in more detail.
- 41 patient was abroad at the 6 months data collection – presenting successful 1 year results
1 patient is no longer contactable – presented successful 3 months results
1 patient did not undergo the planned examinations and additional esophageal manometry showed motility disorder (EMD)
Complications 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 patients5. For daily sufferers the incidence is even higher probably at 20%6. 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 reflux7 and only 1 out of 9 become completely symptom free.7
Therefore, it’s logical that when performing a literature review one cannot find any proof that drug therapy reduces this cancer risk4. With up to 75 million people suffering from Barrett’s esophagus5 and an annual cancer risk of between 0.1-0.5% per year8, this treatment field is in urgent need of a well-working surgical treatment which does not exist today.
The current surgical treatments of acid reflux are all plagued with complications, such as swallowing problems and the inability to burp and vomit, because they all compress the food passageway. RefluxStop™ does not compress the food passageway thereby reducing complications, as supported by the clinical investigation.
- 5Semin Gastrointest Dis. 2003 Jul;14(3):128-35, Barrett’s esophagus and risk of esophageal adenocarcinoma, Cossentino MJ1, Wong RK
- 6Moreira Faulhaber & Weber Furlanetto, Arch Intern Med. 2010
- 7Raghunath AS, Hungin AP, Mason J, Jackson W 2009
- 8Hvid-Jensen F, et al. Incidence of adenocarcinoma among patients with Barrett’s esophagus. New England Journal of Medicine. 2011;365(15):1375–1383. [PubMed
Benefits of RefluxStop™
Treats GERD without affecting food passageway
RefluxStop™ successfully treats acid reflux without affecting the food passageway, thereby minimizing side effects. Current surgical methods compress the food passageway, leading to complications, such as pain when swallowing or the inability to burp or vomit.
Removes the need for drug therapy
In the clinical investigation, at month 6 after RefluxStop™ surgery all patients with evaluable data stopped their daily PPI drug therapy.
Successful clinical trial results
RefluxStop™ clinical investigation showed 95% improvement in measured 24 hour pH in the lower esophagus at months 6 after surgery.
In addition, a validated acid reflux questionnaire (GERD-HRQL) showed a 97,7% improvement in score from before surgery to 6 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 basis9 and around 375 million with daily problems10. GERD has a considerable financial impact on society11.
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.
- 9Zebrowski & fox-tucker, 2006
- 10Stuart 2005
- 11Brook 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.12 This is probably the reason why the cancer risk with Barrett’s esophagus is not reduced by drug therapy.13
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. One relative new treatment is the Linx System, which is a magnetic band that compresses the LES to support the closing.
All of these methods, however, have one major drawback – they all compress the food passageway – thereby causing swallowing problems and the inability to burp 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 100’00014 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 2010.15 Yet only 1 out of 9 drug consumers become completely symptom free, thus there is a large need for a complication-free surgical procedure.
- 12Raghunath AS, Hungin AP, Mason J, Jackson W 2009
- 13The Karolinska Institute Review Article, not yet published
- 14Moreira Faulhaber & Weber Furlanetto, Arch Intern Med. 2010
- 15AstraZeneca 2010