In a two-year TIF study, patients reported 80% improvement in quality of life and reduction or elimination of heartburn symptoms. All patients were instructed to stop taking PPIs two weeks following the procedure; 85% were still off daily PPIs at 12 months and 79% at 24 months.

Reference:
Cadière GB, et al. Two-year results of a feasibility study on antireflux transoral incisionless fundoplication (TIF) using EsophyX. Surgical Endoscopy 2009; 23: 957-964.

To date, TIF has an excellent safety profile. TIF has been performed in over 10,245 cases worldwide with no associated mortalities. Clinical studies demonstrate that TIF patients do not experience long-term complications commonly associated with conventional antireflux surgery such as chronic dysphagia (trouble swallowing), gas bloat syndrome and increased flatulence.

To date, over 10,245 TIF procedures using the EsophyX device have been performed on patients worldwide.

The procedure itself generally takes less than an hour, but may vary from patient to patient.

TIF is a completely incisionless procedure performed safely, quickly and with minimal patient downtime. TIF is called a Natural Orifice Surgery (NOS) procedure because the EsophyX device is introduced into the body through the mouth, rather than through an abdominal incision. The advantages of incisionless surgery over conventional laparoscopic or open antireflux surgery include:

• No visible scars
• Fewer intraoperative, postoperative and long-term complications
• Reduced patient discomfort
• Shortened patient recovery
• Shorter hospital stay
• No associated mortality in 10,245 procedures performed worldwide

Yes, the EsophyX device was cleared by the FDA in 2007 for the treatment of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in patients with symptomatic chronic gastroesophageal reflux disease.

You may go home either the same day of your surgery or the following day, depending upon your specific situation and the recommendations of your healthcare provider. Most patients return to work and normal activities within a few days. Patients should expect to experience some discomfort in their stomach, chest, nose and throat for 3-7 days after the procedure. Patients will also be asked to restrict physical activity for the first week and are given dietary guidelines to help maximize success while tissue heals.

Specific instructions will vary by patient and are at the surgeon’s discretion. For best results, strict adherence to surgeon instructions is highly recommended.

Yes. Clinical research demonstrates that TIF patients maintain normal functions such as the ability to belch and vomit. TIF is a partial fundoplication, which more closely mimics the body’s normal anatomy than a total fundoplication.

On the other hand, a total fundoplication such as the laparoscopic Nissen procedure creates a 360-degree wrap around the esophagus that results in a supraphysiologic (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.

The TIF procedure is most appropriate for those suffering from GERD who:

• Regularly experience troublesome symptoms of GERD
• No longer respond adequately or are dissatisfied with pharmaceutical therapies
• Are concerned about the adverse long-term effects of taking PPIs
• Are considering surgical intervention but are concerned about the complication rate, mortality and potential side effects (e.g. gas bloat, dysphagia, inability to vomit) of laparoscopic antireflux surgery

To determine whether you are an appropriate candidate for TIF, use the Surgeon Locator to consult a qualified TIF surgeon.

Trained and certified TIF surgeons closest to you can be found in the TIF Surgeon Locator.

Costs for the TIF procedure vary according to the hospital, surgeon and patient. Contact a TIF Surgeon to discuss your specific case and the potential costs associated with treatment.

The cost of the TIF procedure can vary depending upon your health plan as well as the surgeon or hospital you choose. If you have questions about whether your insurance provider covers the TIF procedure, contact your plan’s representative directly. Some private health plans may require you or your surgeon to submit paperwork for pre-authorization of an elective surgery.

EndoGastric Solutions has a dedicated team of reimbursement specialists available to assist you, your surgeon and your insurance provider in navigating pre-authorization and coverage for the TIF procedure using the EsophyX device.

TIF Authorization Assistance Program:
EGS offers a full service TIF Authorization Assistance Program, including customized prior authorization requests, pre-determination and first-level appeals, as need arises. For more information contact us:

Phone: 425-307-9224
Fax: 425-491-7407

Patient Advocacy Program:
If you receive a denial from an insurance provider, our team is immediately available to help you launch an appeal to establish the medical necessity of TIF with your payer. For more information contact us:

Phone: 425-307-9223
Fax: 425-984-7018

At EndoGastric Solutions, we are dedicated to advancing surgical intervention for the treatment of GERD. Together, we can educate payers on the limitations associated with conventional antireflux surgery and help them better understand the benefits of an incisionless approach to fundoplication. We stand ready to help you access the most appropriate therapy to treat your GERD.