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Implantica launches RefluxStop in Spain

Implantica has announced that the first two RefluxStop procedures to treat acid reflux have been performed at the Hospital Universitario Getafe in Spain. The procedures were performed by Dr Alberto Hernández, Specialist in General Surgery and Digestive Disorders, under the supervision of Professor Juan Carlos Ruiz de Adana, Head of the Esophagogastric and Bariatric Department. Both patients are doing well and were discharged the next afternoon.

Figure 1: RefluxStop device is invaginated in the fundus wall and thus reinforces the created cuff

"The new technique (RefluxStop) shortens postoperative functional recovery and especially benefits patients with reflux who have esophageal motor disorders, where the classic surgical technique (Nissen fundoplication) has more side effects in the short and medium term. The first results indicate that RefluxStop can cure reflux in 95% of cases without the need for medication. Likewise, it improves reflux control and reduces difficulty swallowing in the medium-long term. As a consequence, in these patients sick leave is shortened and medical follow-up is reduced (review visits, diagnostic tests, reinterventions, pharmacological treatment, etc.), stated a press release from the hospital.

The RefluxStop device is an implantable, non-active, single use device used in the laparoscopic treatment of GERD, which aims to block the movement of the lower oesophageal sphincter (LES) up into the thorax and keep the angle of His in its original, anatomically correct position. According to the device manufacturers, the device restores normal anatomy, leaving the food passageway unaffected.

"It has been a pleasure to implement the new RefluxStop technique at the Hospital Universitario Getafe, which allows a new option for the treatment of gastro-oesophageal reflux patients" said Professor Ruiz de Adana.

The theory behind RefluxStop is that acid reflux is caused by two malfunctioning events, both of which are addressed with this new device. First, the belching process with fundus contraction and simultaneous relaxation of the LES also includes fluid due to the anatomical misalignment of the angle of His. Furthermore, acid reflux is caused by the lower oesophageal sphincter temporarily or permanently entering into the chest. The pressure in the abdomen supports the LES to close while when in the chest, due to the abnormal thorax position with weaker pressure support combined with the breathing process, the closing function is often not working properly resulting in acid reflux. During the breathing process, the diaphragm moves up and down.

RefluxStop reinforces the fundus to interact with the diaphragm for a dynamic treatment of acid reflux. It is placed on the outside of the stomach top fundus wall with laparoscopic surgery. The RefluxStop procedure reconstructs the angle of His and reinforces the top part of the stomach (fundus) by invagination of the device in the pocket created out of the anterior wall of the fundus. 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 (Figure 1). This new device restores normal anatomy (with the LES remaining in the abdomen) by dynamically acting like a mechanical stop against the diaphragm muscle parallel to the LES and the hiatus opening in the diaphragm, leaving the food passageway unaffected. Therefore, side effects associated with ‘gold standard’ surgery are reduced when avoiding compression of the food passageway.

"We are proud to accomplish this milestone for RefluxStop, as the beginning of a strong territorial business expansion in key European markets in 2023,” added Dr Peter Forsell, Founder & CEO of Implantica. “Many thanks to Professor Ruiz de Adana and Dr Alberto Hernández, leading experts from one of Spain's most prominent anti-reflux centers, at the forefront of providing superior acid reflux treatment in Spain. We look forward to continuing our collaboration and helping improve patients' quality of life."


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