The EndoStim system is CE-marked and has been in clinical use in Germany since 2013.
The evaluation was conducted in a six-month pilot study1. 24 GERD patients with residual symptoms despite daily PPI intake, pathological pH-metry, and confirmed esophagitis participated. The EndoStim therapy significantly improved the endoscopic findings and pH-metry. The percentage of time with a pH < 4 decreased from 10.1% to 5.1% over 24 hours. Additionally, sphincter pressure increased significantly, and by the end of the study, 91% of participants were off PPIs. After another six months, the time with a pH < 4 was 3.3%, and 96% of patients were off PPIs2. The stimulation did not lead to unexpected complications. An international multicenter study confirmed these results3. In this study, the pacemaker reduced the percentage of pH time after half a year from 11.3% to 2.6%, and 92% of participants no longer took PPIs.
The long-term results published three years after the first implantation of 21 patients also support the findings4. The period with pH values < 4 decreased from 10.1% to 4.1%. Disease-related quality of life improved significantly over two years, even compared to PPIs. Only four participants continued to take PPIs. Unexpected implant/stimulation-related complications or postoperative dysphagia did not occur. Finally, the interim analysis of an international multicenter study also showed that six months after the implantation of EndoStim, the GERD-related quality of life score of the 17 participants had significantly improved5. 88% of patients no longer needed PPIs. Again, the procedure offered high safety, and there were no stimulation-related gastrointestinal side effects.
Worldwide, EndoStim has been used in more than 160 patients to date, and in Germany, it has been implanted in about 60 patients.