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FAQs About the TIF® procedure.

Is the TIF procedure effective?

The TIF procedure has been evaluated in over 80 published papers from over 60 centers documenting consistent outcomes in over 1300 unique studies of TIF patients. 80% of U.S. patients reported being off daily proton pump inhibitor (PPI) medication and 82% had healed their esophagitis. Please review all safety information.

Is the TIF procedure safe?

To date, physicians have performed the TIF procedure on more than 20,000 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 TIF procedure FDA Approved?

Yes, the FDA gave clearance for the TIF procedure in 2007 for the treatment of chronic reflux (GERD) in patients who require and respond to medical drug therapy. Evidence indicates the device helps narrow the gastroesophageal junction and to reduce hiatal hernia under 2cm in patients with symptomatic chronic reflux (GERD).

I have a hiatal hernia. Can I still get a TIF procedure?

Yes. Clinical data indicates that the TIF procedure can “reduce” hiatal hernias under 2cm. If you have a hiatal hernia larger than 2cm, your TIF trained physician will repair the hernia before your TIF procedure. Both procedures can be performed during the same anesthesia session. While in this case you will have incisions as a result of the hernia repair, you still benefit from the superior performance of the TIF procedure compared to traditional fundoplication.

Is the TIF procedure covered by insurance?

TIF is covered by insurance. The cost of the TIF procedure can vary depending upon your health plan, as well as your choice of surgeon and 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.

How long does the procedure take?

The TIF procedure averages about 30 minutes in duration.

Is the TIF procedure really incisionless?

TIF trained physicians insert the device 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 infections at incision site 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

What is the recovery like?

Typically, you will go home either the same day or the following day, depending upon your individual situation and the recommendations of your physician. Most patients return to non-physical work and resume participating in normal activities within a few days. Patients should expect to experience minor discomfort in their stomach, chest, nose, and throat for three to seven days after the TIF procedure. Physicians will provide dietary guidelines to help maximize success while your valve heals. Specific instructions will vary by patient and are at the physician’s discretion. For best results, follow your physician’s guidance.

Will the TIF procedure alter any of my bodily functions?

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 creates a full 360-degree wrap around the esophagus that results in an over-correction of the reflux valve. Because the wrap is tighter than in normal anatomy, patients can expect limited functions such as swallowing, belching, and vomiting and an increase in flatulence

Are the fasteners used in a TIF procedure safe?

SerosaFuse fasteners help to secure the reconstructed valve. They are very small and are made of the same material that physicians have used for decades for repairs inside the body. Once in place, the body acclimates to the fasteners and often grows tissue around them.

Can the TIF procedure be reversed or revised?

There should not be a need to undo the TIF procedure. The vast majority of patients experience positive outcomes and can eliminate or reduce their need for medical therapy. With the TIF procedure, surgeons will fold tissue inside the stomach at the esophagus junction to reconstruct the valve. In a traditional antireflux surgery, surgeons separate the top part of the stomach from its normal position and wrap it 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 surgery, if necessary.