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First RefluxStop procedures performed in Italy

Updated: Mar 31, 2023

Implantica has announced that the first RefluxStop procedures to treat acid reflux have been performed in Italy, a key market where more than 10 percent of the population struggles with acid reflux disease. 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 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.

Dr Renzi, Head of the Laparoscopic and Minimally Invasive Surgery Unit and High Specialization in Functional Pathologies of the Esophagus and Colorectal, successfully performed the first two RefluxStop procedures in Italy this month. Both patients are doing well and were discharged the next afternoon. Implantica’s RefluxStop provides an innovative way to restore the body’s natural function and address acid reflux disease.

“The RefluxStop procedure restores the natural position of the anti-reflux barrier. It resolves reflux in patients without the common side effects of current surgical procedures, such as dysphagia (difficulty swallowing), gas-bloating, inability to belch or vomit etc. I thank my hospital for their innovative culture, for supporting my training in Bern, Switzerland, with Professor Zehetner, and for offering this solution to my patients,” said Renzi. “I was the first but I will not be the only one, since I know many other leading Reflux surgeons in Italy are considering offering RefluxStop to their patients given the massive urgent medical need to treat acid reflux in Italy, with 11 percent of population impacted.”

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.

“Implantica is proud to partner with Ospedale Buon Consiglio Fatebenefratelli in Napoli, one of Italy’s foremost anti-reflux centers. We want to thank Dr. Renzi and his team for leading the way to offer the RefluxStop innovative technology as a solution to millions of Italian patients suffering from acid reflux. We are excited and look forward to continuing our collaboration,” said Dr. Forsell.


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