EsophyX™
What is EsophyX™?
What is GERD?
GE Valve intact
Funnel-shaped GE Valve
What causes GERD?
GERD is caused by a failure of the antireflux barrier (ARB) and its primary component, the GastroEsophageal valve (GEV). The understanding of the GEV has continued to progress in recent years, and more focus is currently being placed on the GEV, rather than the lower esophageal sphincter (LES) as the largest contributor to the ARB. In healthy patients, the Angle of His, the angle at which the esophagus enters the stomach, is intact creating a valve that prevents duodenal bile, enzymes, and stomach acid from traveling back into the esophagus where it can cause burning and inflammation of the sensitive esophageal tissue.
Other factors that may contribute to GERD symptoms include:
- excessive weight
- smoking
- eating fast
In addition, consuming certain foods and drinks may contribute to an increase in GERD symptoms:
- citrus fruits & juices
- chocolate
- caffeinated & carbonated drinks
- tomato-based foods & sauces
- spicy foods
- fatty & fried foods
- garlic & onions
- food items & teas containing mint
- alcoholic beverages
- eating large meals
- eating late at night
- pregnancy
Transoral Incisionless Fundoplication (TIF)
EsophyX™ Transoral Incisionless Fundoplication (TIF) is the third wave in the evolution of surgical procedures for the treatment of GERD and builds upon the principles of open and laparoscopic surgical procedures. EsophyX™ TIF delivers similar benefits as the time-proven laparoscopic antireflux procedures, by reducing hiatal hernia, recreating the Angle of His, and creating a Gastroesophageal Valve (GEV). The key differences are that EsophyX™ TIF is a transorally performed non-invasive procedure (through the mouth), does not require incisions, and does not dissect any part of the natural internal anatomy.
EsophyX™ TIF is a surgical procedure for the treatment of GERD that aims to restore the antireflux (ARB) by creating a GEV. In addition to restoring the GEV, the EsophyX™ TIF procedure:
- establishes the Angle of His
- achieves serosa-to-serosa fusion
- lengthens the intraabdominal esophagus
- reduces hiatal hernia
While emulating principles of the Antireflux Surgery (ARS), the EsophyX™ TIF procedure is intended to reduce invasiveness, allow for faster recovery, and be more versatile than open or laparoscopic surgery.
The device has been designed to deploy multiple tissue fasteners to create a robust and durable ARB valve and the TIF procedures can be tailored for the specific patient and anatomy. Histological samples of preclinical studies confirmed that EsophyX™ TIF procedure creates a valve that incorporates serosa-to-serosa fusion.
In addition it could be demonstrated that the phrenoesophageal ligament is incorporated into the valves, stabilizing and strengthening the valve, firmly anchoring it to the diaphragm. Based on EU phase II Multi-Center data, EsophyX™ TIF procedures reduce adverse effects known from ARS like dysphasia and gas bloat syndrome, reduce pain, and reduce hospital stays as compared to ARS. EsophyX™ TIF is a very physiological approach to restoring the natural anatomical configuration of the ARB of the Gastroesophageal Junction (GEJ).
EsophyX™ TIF is an alternative to surgical, or pharmaceutical approaches to treating GERD. Because it is less invasive compared to surgery, EsophyX™ significantly expands the group of GERD patients that can benefit from an anatomical repair. Transoral Incisionless Fundoplication employs mechanical techniques to reinstate the anatomy observed in healthy individuals by restoring the mechanical gastroesophageal barrier, a GEV.
EsophyX™ is FDA cleared and CE marked, and available in the USA and the European Union.
