Five-year RefluxStop outcomes demonstrate favourable food passageway-related outcomes
- owenhaskins
- 23 minutes ago
- 2 min read
RefluxStop surgery (developed by Implantica) results in a favourable profile of food passageway-related outcomes throughout the five-year study with no adverse events (AEs) dysphagia in 97.9% of subjects and no AE odynophagia in 97.9% of patients.
“A few data points from a large recently published literature review on standard of care Nissen fundoplication are helpful to provide an indirect comparison and offer some perspective on how extraordinary the RefluxStop five-year results are, “ said Dr Peter Forsell, Implantica CEO and founder. “Nissen fundoplication at five years presented with: dysphagia in 28.9%, gas bloating in 52.7% and inability to belch and vomit in 39.8%. The difference in outcomes are of such magnitude that they support an edict to a paradigm shift in acid reflux treatment. Publication of this study marks the dawn of a new era in the surgical treatment of GERD, one in which patients will have an innovative surgical treatment available that can restore the natural function of their body with minimal food passageway-related sequelae.”
Standard surgical management of GERD can result in troublesome postoperative food passageway-related sequelae (i.e., dysphagia, odynophagia, gas-bloat syndrome, inability to belch/vomit), significantly impacting quality of life, according to an international team of researchers. Therefore, they assessed the impact of the RefluxStop procedure - involving reconstruction of the anti-reflux barrier without encircling the food passageway - in reducing such related sequelae.
The RefluxStop procedure aims to restore the normal healthy anatomy at the base of the oesophagus. The RefluxStop device is a non-active implant that is placed on the upper part of the stomach through laparoscopic surgery. RefluxStop surgery was evaluated in a prospective, single-arm, multi-centre study with 50 GERD subjects. This report focuses on food passageway-related outcomes.
Forty-four subjects completed five-year follow-up; three participants were missing due to COVID-19 (i.e., two deaths and one bedbound with long-COVID) and three terminated early. Data from three- and four-year follow-up were carried forward in COVID-affected cases. Food passageway-related adverse events (AEs) between two weeks of surgical recovery and five-year follow-up included: one case (2.1%) of dysphagia (and another case, mild dysphagia for 2 weeks postoperatively, viewed as normal recovery); one case (2.1%) of odynophagia; zero (0%) cases of inability to belch/vomit; and gas-bloating none/improved in 42 cases with only two worsening.
These outcomes were well-aligned with improvement in total GERD-HRQL score (i.e., median 29.5 at baseline to 3.0 at five years), PPI usage (2.1%), and 24-h pH monitoring (i.e., mean 1.57% acid exposure time at five years). For clinical correlation, 97.9% of subjects did not take PPIs at five years.
“With a potential US approval, pending FDA approval, in the near future, we are very excited about the opportunity to bring RefluxStop to highly underserved GERD patients in the US (where the disease affects 22-27% of the US population) where RefluxStop’s unique non-encircling mechanism of action reduces side effects,” he added.
The findings were reported in the paper, ‘Food passageway-related sequelae in the RefluxStop prospective multicenter trial: patient-centric outcomes of dysphagia, odynophagia, gas-bloating, and inability to belch and/or vomit at 5 years’, published in Surgical Endoscopy. To access this paper, please click here