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Frequently Asked Questions

Following are some frequently asked questions (FAQs) about the TIF procedure using the EsophyX device.

Safety & Effectiveness

- Is the TIF procedure effective?
The TIF procedure has been evaluated in over 70 published papers from over 50 centers documenting consistent outcomes in over 1200 unique study TIF patients; 75% of U.S. patients reported being off daily proton pump inhibitor (PPI) medication and 82% had healed their esophagitis. Please review all safety information

Reference:
Data cited is based on calculations made from weighted averages in published literature and is regularly updated.

- Is the TIF procedure safe?
To date, the TIF procedure has been performed on more than 18,000 cases worldwide with minimal complications and a serious adverse event rate under 0.5%. Clinical studies demonstrate that properly selected TIF patients rarely experience long-term side effects commonly associated with traditional antireflux surgery, such as chronic trouble swallowing, gas bloat syndrome, and increased flatulence.

- Is the EsophyX device used in the TIF procedure cleared for use by the FDA?
Yes, the EsophyX device was cleared by the FDA in 2007 for the treatment of chronic GERD in patients who require and respond to medical drug therapy. It is also indicated to narrow the gastroesophageal junction and to reduce hiatal hernia ≤ 2cm in patients with symptomatic chronic GERD.


Eligibility

- Am I an appropriate candidate for the TIF procedure?
The TIF procedure is most appropriate for those suffering from GERD who: 

  • Regularly experience troublesome symptoms of GERD
  • No longer respond adequately to, or are dissatisfied with, pharmaceutical therapies
  • Are concerned about the adverse long-term potential side-effects of taking PPIs
  • Are considering surgical intervention 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

- I have been told that I have a hiatal hernia; can I still undergo a TIF procedure?
The EsophyX device used in the TIF procedure is indicated to “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. See attached disclaimer PDF which includes a full list of indications and contraindications.
We are aware that within the practice of medicine, surgeons have laparoscopically repaired hiatal hernias larger than 2cm in a separate and/or concomitant procedure followed by a TIF procedure. The decision to perform a hiatal hernia repair followed by a TIF procedure is strictly made between the surgeon/patient as the Company does not have clinical data to support/promote this.
For further reference, here’s a link to a recent study published September 2015 that measured hiatal hernias before a TIF procedure: http://www.ncbi.nlm.nih.gov/pubmed/26460056. Your physician may also have a subscription to the American Journal of Surgery to review the data.


Cost

- How much does the TIF procedure cost?
Costs for the TIF procedure vary according to the hospital, physician, individual insurance plan, and each patient’s health situation. Contact a TIF trained physician to discuss your specific case and the potential costs associated with treatment.

- Is the TIF procedure covered by insurance?
The cost of the TIF procedure can vary depending upon the health plan as well as a patient’s selection of a surgeon or hospital. For questions about insurance coverage of the TIF procedure, contact a health plan’s representative directly. Some private health plans may require the patient or surgeon to submit paperwork for pre-authorization of an elective surgery. EndoGastric Solutions has a dedicated team of reimbursement specialists available to help you navigate the pre-authorization and coverage for the TIF procedure with EsophyX device.

During The Procedure


- How long does the TIF procedure take?
The TIF procedure itself generally takes less than an hour, but may vary from patient to patient.

- Is the TIF procedure truly incisionless?
TIF is an acronym T = Transoral, I = Incisionless, F = Fundoplication and is performed safely, quickly, and with minimal patient downtime. The EsophyX device is inserted through the mouth rather than through an abdominal incision. The advantages of an incisionless procedure over conventional laparoscopic or open antireflux surgery include: 

  • 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

Toomey, P., et al; American Surgeon, Volume 80, Number 9, September 2014, pp. 860-867(8) Vol 80, No 9, Sept 2014, pp. 860-867(8)


After The Procedure

- What is the recovery like?
A patient may typically go home either the same day or the following day, depending upon his/her specific situation and the recommendations of his/her healthcare provider. Most patients return to work and resume participating in normal activities within a few days. Patients should expect to experience some discomfort in their stomach, chest, nose, and throat for three to seven days after the TIF procedure. Patients will also be asked to restrict physical activity for the first weeks and are given dietary guidelines to help maximize success while tissue heals. Specific instructions will vary by patient and are at the physician’s discretion. For best results, strict adherence to physician instructions is highly recommended.
 

- Will the TIF procedure alter any of my bodily functions?
No. Clinical research demonstrates that TIF patients maintain normal functions such as the ability to belch and vomit. The TIF procedure is a partial fundoplication, which more closely mimics the body’s normal anatomy. 

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, functions such as normal amounts of reflux, belching, and vomiting may be limited.

-Are fasteners staying permanently in my body? Does this create any short term or long term risk?
The fasteners stay permanently in the body, but they are too small to be noticed and do not disrupt any bodily functions. SerosaFuse fasteners are used to secure the reconstructed valve. They are very small and are made of the same material that surgeons have used for decades to sew tissue inside the body. Once in place, the body acclimates to the fasteners and often grows tissue around them. 

A simple way to describe how the fasteners are applied is to 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 tissue. The fastener opens forming an “H” shape on either side of the two layers. The bridge in the middle holds the tissue together while the body knits the two layers together.

-Can the TIF procedure be revised (corrected or redone)?
A TIF procedure can be revised either with a subsequent TIF procedure or with a laparoscopic Nissen fundoplication. In addition, patients may resume PPI therapy, if necessary, to help control GERD symptoms. While uncommon, revisions have been successfully reported in clinical literature: Bell RC, Kurian AA, Freeman KD. Surg Endosc. 2014 Nov 8. [Epub ahead of print]

-Can the TIF procedure be reversed (undone)?
No. There should not be a need to undo the TIF procedure. Most patients experience positive outcomes and can eliminate or reduce their need for therapy. For those patients who may experience recurrent symptoms, you and your physician will identify additional treatment options to help manage your GERD.

-Can I have a traditional anti-reflux surgery if the TIF procedure fails down the road?
Yes. With the TIF procedure, tissue is being folded inside the stomach at the esophagus junction to reconstruct the valve. In a traditional surgery, the top part of the stomach is cut away from its normal position and wrapped around the outside of the esophagus. This difference between inside and outside tissue manipulation is what allows patients the option to have the TIF procedure and still be eligible for a traditional procedure if necessary. Bell RC, Kurian AA, Freeman KD. Surg Endosc. 2014 Nov 8. [Epub ahead of print]

For more information on the TIF procedure, view this site: www.GERDHelp.com.

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