BACKGROUND
RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected.
METHODS
In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction.
RESULTS
There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects.
CONCLUSION
The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.