Implantica has announces finalisation of the five-year CE mark study results as part of the upcoming Module 2 submission (of 3 modules) of the RefluxStop premarket approval application (PMA) to the FDA. Implantica has prepared responses to FDA’s feedback from Module 1 to be submitted together with Module 2 of the RefluxStop PMA application. Module 2 is planned to be submitted in the near-term (third quarter of 2024) as agreed with the FDA.
"Our independent data handling partner, together with our CRO, have now performed data auditing and analysed our CE mark study five-year data. We are so pleased to see the fantastic final results of the CE mark study that are largely in line with recently published excellent four-year results and several independent published real-world outcomes,” said Implantica’s CEO, Dr Peter Forsell. “These results will echo around the world and will significantly advance RefluxStop’s position as a potential leading treatment option for the hugely underserved GERD patients.”
RefluxStop is an innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. According to the company, it’s unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GORD involve encircling the food passageway to support the lower oesophageal sphincter’s closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit. In contrast, the RefluxStop device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower oesophageal sphincter in its original, natural position.
The RefluxStop mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux.
Module 2 is the most important of the three modules included in the PMA filing and will contain the clinical and usability data, including the results of the CE-mark clinical investigation and the results from its Human Factors Validation Study performed earlier this year with 16 US foregut/reflux surgeons in Chicago.
A summary of the objective and exceptional 5-year clinical results from the CE mark study shows:
Contrast swallow x-rays at year five show the devices in place and well-functioning with no device dislocations, no device migration, and no re-herniation.
24-hour pH monitoring, measuring the acidity in the lower oesophagus over 24-hours, also provides excellent results. Only one subject is dissatisfied and has a failed/pathologic 24-hour pH monitoring test.
In comparison, the main device competitor at their FDA trial reported 42% pH test failures at year one.
“Many of the articles published in prominent journals, such as Nature and Surgical Endoscopy, present consistent excellent outcomes, including the most recent results from one of Germany’s largest Reflux centers in Frankfurt performing about 250 surgeries per year, presented by Dr Moustafa Elshafei,” added Forsell. “With over 50 RefluxStop procedures completed, Dr. Elshafei’s results are in line with our pivotal CE mark study results, showing no serious complications or reoperations that once again reinforce similar outcomes witnessed by many of the other RefluxStop users in Europe.”
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