Focus of the Report: The focus of this Health Technology Assessment (HTA) is to evaluate the effectiveness and safety of transoral incisionless fundoplication (TIF) 2.0 using EsophyX (EndoGastric Solutions Inc.) to treat chronic gastroesophageal reflux disease (GERD) in adults.

Technology Description: TIF 2.0 using EsophyX is a minimally invasive alternative to open and laparoscopic fundoplication and is the most recent iteration of a transoral procedure to create an antireflux barrier at the junction of the stomach and the esophagus. During TIF 2.0, the EsophyX device is introduced through the mouth and down the throat to the gastroesophageal valve. The device is used to retract the tissue around the base of the esophagus and create a 3-centimeter–long 270° valve with 12 to 23 implantable fasteners.

Controversy: Laparoscopic fundoplication is effective for the treatment of GERD and is less invasive than open fundoplication, but it still leaves a scar and carries the possibility of complications. TIF 2.0 has been available since 2009 and is one of several minimally invasive treatments for GERD that is not fully responsive to medication. The long-term effectiveness of TIF 2.0 and its effectiveness compared with similar treatments and with standard care is unclear.

Key Questions:

  1. Is TIF 2.0 with the EsophyX device effective for the treatment of GERD in adults?

  2. How does TIF 2.0 compare with other treatments for GERD?

  3. Is TIF 2.0 with EsophyX in patients with GERD safe?

  4. Have definitive patient selection criteria been identified for TIF 2.0 with EsophyX for GERD?

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