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| Device | RefluxStop® Device and RefluxStop® Deployment Tool |
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| Generic Name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
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| Applicant | Implantica CE Reflux , Ltd.
Sir Temi Zammit Bldg.S, Malta Life Sciences Park
San Gwann SGN3000 |
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| PMA Number | P250018 |
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| Date Received | 06/23/2025 |
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| Decision Date | 08/20/2026 |
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| Product Code |
LEI |
| Advisory Committee |
Gastroenterology/Urology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
REVEAL: A post-market study to assess safety and effectiveness of RefluxStop® in the treatment of Gastroesophageal Reflux Disease (GERD) in general hospital practice New Enrollment PAS (Study Number RXI009, Version 7.0, dated July 30, 2026): This is a prospective, single-arm, multi-center study designed to evaluate the short- and long-term safety and effectiveness of RefluxStop in the treatment of GERD. The PAS will enroll a total of 200 patients with hiatal hernia size = 3 cm will be implanted with RefluxStop and followed for 5 years. Study participants will be enrolled at up to 10 clinical sites (minimum of 4 sites), with at least 50% of sites located in the United States and at least half of all procedures conducted at U.S. sites.The primary safety endpoint is the incidence of procedure- and device-related serious adverse device effects (SADEs), serious adverse events (SAEs) and device deficiencies (DDs) at 1 year. The rate of this composite endpoint will be compared to a performance goal (PG) of 16.2%. The primary effectiveness endpoint is pathologic acid in the lower esophagus measured by 24-hour pH monitoring (total percentage of time pH <4) at 1 yearSecondary study endpoints are as follows. Secondary safety endpoints include: incidence of procedure- and device-related SADEs, SAEs and DDs at all time points excluding at year 1, comprising month 6 as well as years 2 to 5; and incidence of procedure- or device-related Adverse Events (ADEs or AEs) at 6 months and annually thereafter up to 5 years. Secondary effectiveness endpoints include: subjects with <50% improvement of GERD-HRQL since baseline due to GERD; reduction in GERD-HRQL group score, measured at 6 months and years 1 to 5 compared to baseline; regular daily PPI usage due to GERD/acid reflux at 6 months and years 1 to 5; total percentage of time pH <4 measured by 24-hour pH monitoring at year 1; pathologic 24-hour pH monitoring and on-label device position at years 2 to 5; and incidence of inability to belch at 6 months and at years 1 to 5.The main 1-year safety and effectiveness endpoints will be analyzed as follows:• The incidence of procedure- and device-related SADEs, SAEs and DDs at year 1 (primary safety endpoint) will be compared to a performance goal of <16.2%.• Proportion of patients having pathologic 24-hour pH monitoring at year 1 (primary effectiveness endpoint) will be compared to a performance goal of 40%. • Proportion of patients having <50% improvement of GERD-HRQL score at year 1 compared to baseline (secondary effectiveness endpoint) will be compared to a performance goal of <40%.For each of the three evaluations of 1-year endpoints, a descriptive summary will be provided on the observed rates compared to the defined performance goals.In addition, a long-term evaluation of device performance will be conducted by comparing 5-year endpoints in the PAS to long-term results following Nissen fundoplication based on literature.Descriptive analysis will be conducted on all other clinical endpoints. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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