Implantica has announced the start of its marketing process in the US and preparations for a potential US approval following data presentations for its RefluxStop device.
The data was presented as two independent abstracts at the 2023 Annual Swiss College of Surgeons Congress (SCS) in Basel.
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RefluxStop is a device that addresses acid reflux without affecting the food passageway. Its mechanism of action restores and supports the natural anatomical physiology of the body. It focuses on reconstructing all three components of the anti-reflux barrier, which if compromised could possibly result in acid reflux.
RefluxStop for gastroesophageal reflux disease (GERD)
A total of 45 patients with gastroesophageal reflux disease (GERD) who received a laparoscopic implantation of RefluxStop reported a significant reduction in the GERD -HRQL score from baseline to six weeks post-operation (23.9 and 4.3). Furthermore, the scores were also reduced at the last follow-up after a median of 3.2 years (6.8, p = 0.021).
The GERD-HRQL questionnaire is a validated method to measure changes in typical GERD symptoms such as heartburn and regurgitation, in response to surgical or medical treatment.
At a median follow-up time of 3.2 years post-surgery, primary presenting symptoms were gone in 31 patients, improved in six patients, and stayed the same in two patients.
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By GlobalDataTypical symptoms were gone or improved in 34 of the 37 patients (92%). In 12 of the 15 patients, dysphagia and pain were resolved or improved. Respiratory symptoms were resolved or improved in all 14 patients.
RefluxStop for hiatal hernia with reflux symptoms
In a retrospective chart review, 30 patients with hiatal hernia with oesophageal dysmotility who underwent hiatal hernia surgery with RefluxStop were assessed for a 12-month follow-up.
Among 30 patients, the mean GERD Health-Related Quality of Life (GERD-HRQL) score (from 0-75 points) was reduced from 37.6 ± 15.8 before surgery to 4.4 ± 6.9 after one year.
The reported adverse events upon follow-up included persistent dysphagia requiring treatment (three patients), asymptomatic partial migration of the implant (one patient), recurrence of hiatal hernia after 2 years in patients who required surgical repair (one patient), and persistent left thoracic pain requiring implant removal (one patient).
CEO of the Switzerland-based company, Dr Peter Forsell, stated: “Motility disorder is a field where no optimal treatment exists today, as patients suffer from more frequent and severe swallowing difficulties and often pain. The disadvantage with the current standard of care, fundoplication, is that it encircles the food passageway and often causes these symptoms to worsen.”
