Implantica Achieves Milestone with RefluxStop® Clinical Study
Implantica AG, a prominent medtech company, is making waves in the healthcare industry with its innovative device, RefluxStop®. This significantly impacts the treatment of acid reflux, a condition affecting approximately 1 billion people globally. The recent publication of their 5-year clinical trial results showcases compelling long-term outcomes for patients using RefluxStop®, presenting a potential shift in treatment methodologies.
Remarkable Results from the 5-Year Study
The publication of the results in the renowned journal, Surgical Endoscopy, underlines the successful outcomes related to food passageway issues. The study's focus on conditions such as swallowing difficulties and gas-bloating further emphasizes the benefits of this innovative approach in treating gastroesophageal reflux disease (GERD).
Key findings from the clinical study include:
- 97.9% of participants reported no difficulties swallowing (dysphagia).
- 97.9% experienced no painful swallowing (odynophagia).
- 95.7% found improvement in gas-bloating or an elimination of symptoms.
- 100% maintained the ability to belch or vomit.
Innovative Treatment Approaches Highlighted
This groundbreaking study, titled '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', generated substantial interest at the recent SAGES 2025 conference. Dr. Jörg Zehetner, who delivered an engaging oral presentation on the study, highlighted the transformative potential of RefluxStop®.
Dr. Peter Forsell, CEO and founder of Implantica, noted that direct comparisons to traditional treatments like Nissen fundoplication show a remarkable difference in outcomes. For instance, 28.9% of patients undergoing the traditional procedure had difficulties with swallowing after 5 years, while the RefluxStop® users reported significantly better results. This disparity sheds light on the paradigm shift that RefluxStop® offers, promoting a more natural function of the esophageal sphincter with fewer complications.
Future Potential of RefluxStop® in the U.S. Market
With the potential for upcoming FDA approval, the enthusiasm surrounding RefluxStop® is palpable. This treatment presents a unique non-encircling mechanism, promising significant reductions in adverse side effects commonly associated with other GERD treatments. Dr. Forsell expressed optimism about introducing this innovative solution to a substantial number of underserved GERD patients in the U.S., where the condition significantly impacts 22-27% of the population.
About Implantica and RefluxStop®
Implantica strives to enhance healthcare through advanced medical technology. The company’s lead product, RefluxStop®, is CE-marked and recognized for its potential to revolutionize the approach to gastroesophageal reflux. Their commitment extends beyond surgical solutions, as they also work on eHealth technologies aimed at monitoring health parameters and supporting patient care from within the body.
For professional inquiries, please contact:
Nicole Pehrsson, Chief Corporate Affairs Officer
Telephone (CH): +41 (0)79 335 09 49
Frequently Asked Questions
What is RefluxStop®?
RefluxStop® is an innovative device designed to treat gastroesophageal reflux disease (GERD) by restoring the natural function of the lower esophageal sphincter without encircling it.
What were the key findings of the 5-year study?
The study revealed impressive long-term success rates, with 97.9% of patients reporting no swallowing difficulties and 100% maintaining the ability to belch or vomit.
How does RefluxStop® differ from traditional treatments?
Unlike traditional methods like Nissen fundoplication that encircle the esophagus, RefluxStop® maintains the natural anatomy, resulting in fewer adverse side effects.
Is RefluxStop® available in the United States?
Currently pending FDA approval, RefluxStop® can soon address the needs of many GERD patients in the U.S.
Where can I learn more about Implantica?
For additional information, you can visit Implantica's official website.
