TIF 2.0® Overview

An Effective Solution for Chronic Acid Reflux

The transoral incisionless fundoplication is a minimally invasive treatment for gastroesophageal reflux disease (GERD) that is performed in the outpatient setting. The TIF procedure is performed from inside the patient’s stomach without incisions. This procedure delivers patient outcomes similar to those provided by conventional ARS procedures, but is less invasive, has fewer adverse effects, and does not limit future treatment options. Following the principles of ARS, the TIF procedure repairs the anti-reflux barrier by reducing a hiatal hernia (≤ 2 cm), and creating a valve 2 to 4 cm in length and greater than 270 degree circumferential wrap, thus restoring the dynamics of the angle of His.

A Less Invasive Approach to Fundoplication

Fundoplication procedures have been used to effectively treat patients with GERD for over 50 years. The TIF procedure differs from a traditional fundoplication procedure because it is performed through the mouth rather than through laparoscopy or open abdominal incisions.

The TIF® 2.0 procedure (with or without a laparoscopic hiatal hernia repair) restores anatomy and reconstructs the gastroesophageal flap valve while maintain an exemplary safety profile with minimal side-effects

During a TIF procedure, the patient is placed under general anesthesia so that the EsophyX device, used with a flexible endoscope, can be gently introduced into the stomach under constant visualization. The endoscope and the device are retroflexed and a helical retractor is engaged into the tissue slightly distal to the Z line. The fundus of the stomach is folded up and around the distal esophagus utilizing the tissue mold and chassis of the device. After locking all the tissue manipulating elements, an integrated suction apparatus is activated to gently grasp the distal esophagus and position it in the abdominal cavity distal to the diaphragm. H-shaped SerosaFuse fasteners, made of polypropylene with strength equivalent to 3-0 sutures, are then delivered through apposed layers of esophageal and fundus tissue to anchor the repair. This process is repeated to create a full thickness, partial circumference, gastroesophageal fundoplication. Approximately 20 fasteners are implanted during the procedure to create fusion of the esophageal and fundus tissues and form the valve.

Evolution of the TIF Procedure
The TIF procedure that is currently performed in the United Sates is the result of several iterations of development. The original variation of the procedure performed early in U.S. experience, and predominantly in Europe was known as endoluminal fundoplication (ELF). This first generation procedure was developed to assess the feasibility of the approach, and was designed–first and foremost–to demonstrate safety and efficacy. At the time, investigators were concerned with placing fasteners through the distal esophagus and elected instead to create gastro‐gastric plications distal to the gastroesophageal junction. After experience was gained with the first generation procedure and devices, subsequent iterations of the technique were pursued to more closely replicate the principles and outcomes of traditional surgical procedures.

NameAcronymFastener PlacementPlication TypeWrap
Endoluminal FundoplicationELFBelow Z lineGastrogastricNo
Transoral Incisionless Fundoplication
1.0
TIF 1.0Above Z line
1 cm
EsophagogastricNo
Transoral Incisionless Fundoplication
2.0
TIF 2.01-3 cm above Z line;
more length along greater curve of the stomach
EsophagogastricYes

Table highlighting evolution of the transoral fundoplication.

Adherence to Established Principles of Anti-reflux Surgery

Transoral fundoplication is designed to treat the symptoms of GERD, while minimizing post-operative side effects such as dysphagia, gas bloat, and flatulence. The success of the TIF procedure can be traced to its foundation in the established principles of traditional antireflux surgery[1-4].

Learn more here about how transoral incisionless fundoplication compares to traditional surgery.

Healthcare professionals can learn more about the TIF procedure by contacting us.

For patients interested in more information, please visit GERDHelp.com to locate a physician trained to perform TIF procedures.

References:
[1] Jobe, B.A., et. al. Endoscopic Appraisal of the Gastroesophageal Valve After Anti-reflux Surgery. Am J of Gastro 2004.

[2] Little, A., et. al. Mechanisms of Action of Anti-reflux Surgery: Theory and Fact. World J of Surg. 1992;16:320-5.
[3] Nissen R, The Treatment of Hiatal Hernia and Esophageal Reflux by Fundoplication. Hernia 1964;30:488-496.
[4] Adler, R.H., et. al. A valve mechanism to prevent gastroesophageal reflux and esophagitis. Surgery 1958;44:63-75.
[5] Choi et al. J AM Coll Surg. 2021 Mar;232(3):309-318.

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