Below we’ve collected some frequently asked questions (FAQs) about the TIF procedure using the EsophyX device.
Safety & Effectiveness of the TIF Procedure
Patient Eligibility for the TIF Procedure
- Regularly experience troublesome symptoms of GERD
- No longer respond adequately to, or are dissatisfied with, pharmaceutical therapies
- Are concerned about the negative side-effects associated with long-term dependence on PPIs
- Are considering traditional surgery but are concerned about the potential side effects (e.g. gas, bloating, difficulty swallowing, inability to vomit) and complication rates for laparoscopic antireflux surgery
Trained and certified TIF physicians are best able to assess your clinical situation relative to established patient selection criteria; you can find one near you with the TIF Physician Locator by searching zip code or states.
Yes. Clinical data indicates that the EsophyX device used in the TIF procedure can “reduce” hiatal hernia under 2cm. Patients selected in clinical studies comply with this FDA indication and data suggests that is one of many appropriate criteria.
In the past decade, many physicians have laparoscopically repaired hiatal hernia’s greater than 2cm immediately prior to the TIF procedure (during the same anesthesia session). Several physicians published data which was submitted to FDA for review. In June 2018, the label for the EsophyX device was officially expanded to include patients whose hiatal hernia’s were laparoscopically repaired.
Cost of Having the TIF Procedure
During The Procedure
- No visible scars
- No risk for skin infection (as there are no skin incisions)*
- Fewer complications during and after surgery
- Reduced patient discomfort
- Shortened patient recovery
- Shorter hospital stay
- Few of the typical long-term side effects from traditional surgical approaches
*If you require a laparoscopic hiatal hernia repair immediately prior to a TIF procedure, you will have a few small incisions. The recovery process is the same either way.
After The Procedure
In contrast, a traditional fundoplication such as the laparoscopic Nissen procedure creates a full 360-degree wrap around the esophagus that results in a “supra-physiologic” (literally translated: “more than is natural”) antireflux valve. Because the wrap is tighter than in normal anatomy, patients can expect limited functions such as normal amounts of reflux, belching, and vomiting.
There is a simple way to envision how the fasteners are applied. Imagine how a plastic price tag attaches to a piece of clothing. The fasteners are like that, but a much smaller version. The fastener rides along a very small needle that glides through two layers of stomach and esophageal tissue. The fastener opens forming an “H” shape–one side of the H is on the stomach side, the other is on the esophageal side. The bridge in the middle holds the tissue together while the body knits the two layers together (technically called serosal fusion).