EsophyX - Model TIF 2.0 - Transoral Reconstructive Surgery Device
The EsophyX device is designed to reconstruct the gastroesophageal valve (GEV) and help restore the GEV’s function as a reflux barrier. It is used to perform the TIF® procedure — Transoral Incisionless Fundoplication — by enabling the creation of a 2-3 cm, 270° esophagogastric fundoplication. The device is a fastener delivery system and utilizes proprietary tissue manipulating elements to deploy approximately 20 SerosaFuse fasteners. A flexible video endoscope is inserted into the central lumen of the EsophyX device to provide direct visualization throughout the TIF procedure
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Details
- Helical Retractor
- Engages and retracts tissue
- Anchors gastroesophageal junction during fundoplication
- Stows/locks safely inside tissue mold during insertion and removal
- Tissue Mold and Chassis
- Plicates and compresses tissue
- Rotates fundus around esophagus to create partial wrap
- Invaginator
- Suctions tissue circumferentially
- Reduces small hiatal hernia
- Facilitates proper position of fundoplication caudal to diaphragm
- Stylets and SerosaFuse® Fasteners
- Transect apposed tissues
- Fasteners maintain tissue compression throughout healing process
TIF vs Anti-Reflux Surgery
Anti-reflux Surgery[1-5]
The goal of antireflux surgery is to restore the normal functions of the junction between the esophagus and the stomach. This is carried out by wrapping the upper portion of the stomach (the fundus) around the esophagus, either partially or totally. Both the TIF procedure and traditional antireflux surgery have the same goal.
Benefits of the TIF procedure:
- No scars, due to incisionless approach
- Faster recovery, since there is no internal cutting of the natural anatomy
- Fewer adverse events and complications than conventional surgery
- Can be revised if required
The purpose of the surgery is to:
- Reduce a hiatal hernia (if present) by repairing the enlarged opening in the diaphragm
- Ensure proper positioning of the stomach and esophagus below the diaphragm
- Restore the angle at which the esophagus enters the stomach
- Increase the pressure of the LES (lower esophageal sphincter) to prevent reflux and restore one-way valve operation
Treatment Options
Among the treatments available to people with severe GERD-related symptoms, the more advanced options are the TIF procedure and traditional antireflux surgery.
Traditional, or conventional, antireflux surgery has been long considered an effective solution for treating GERD. The surgery involves several abdominal incisions and typically includes side effects such as difficulty swallowing (26%), bloating (36%), and increased flatulence (65%).
The TIF (Transoral Incisionless Fundoplication) procedure for chronic acid reflux treats the underlying cause of GERD without incisions. This procedure rebuilds the antireflux valve and restores the body’s natural protection against reflux. It follows the well-established principles of conventional antireflux surgery and delivers similar results in an innovative way.
Comparison of the TIF Procedure and Traditional Anti-reflux Surgery
The main differences between the TIF procedure and traditional antireflux surgery are:
- No Incisions: Conventional antireflux surgery involves accessing the anatomy via 3-5 abdominal incisions. The TIF procedure does not require any incisions as it is performed through the patient’s mouth. This difference leads to less patient discomfort.
- No Dissection: Certain antireflux surgeries require the surgeon to cut around anatomy, which can increase the risk of complications and adhesions and can prolong recovery time. The TIF procedure does not require cutting.
- Excellent Safety Profile: To date, more than 27,000 TIF procedures have been performed with fewer complications than conventional antireflux surgery.
Due to the unique approach of the TIF procedure, you will most likely be able to return to work and normal activities within a few days after your TIF procedure. This lets you get back to your life sooner, free of the distraction and discomfort of GERD.
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