Shaping the Future of GERD Management, featuring a panel of two gastroenterologists and one surgeon: Updates on the TIF 2.0 Procedure with EsophyX® Device Spectrum of Care – Tailored approach to treating GERD by Barham K. Abu Dayyeh, MD, MPH. Why TIF procedure? Why Now? Evolution, updated device, current data, patient selection by Kenneth J. Chang, MD. Hiatal Hernia Repair and Concomitant Transoral Fundoplication by Dr. Peter Janu MD.

Spectrum of Care – Tailored approach to treating GERD treatment. Barham K. Abu Dayyeh, M.D., M.P.H.

Dr. Abu Dayyeh opens by quantifying the cost of GERD, both typical and A-typical at $59 billion for the US healthcare system, equaling the cost of taking care of all cancers in the US. He notes that GERD is not a hypersecretory disorder, but rather reflux is the result of a pathophysiological defect at the GE-junction preventing the valve from working properly. He emphasizes the importance of classifying anatomic abnormalities to give the right therapy to the right patients. For patients with clearly normal anatomy, and this is about 65%, with a Hill grade 1, then it’s fine to offer these patients PPI.

Dr. Abu Dayyeh emphasizes the importance of measuring the Hill grade in the upper endoscopy report. He then looks at the valve function of normal anatomy with a Hill grade 1 and how to measure the hiatus. He talks about situations where there is a defect in the valve and anatomical correction is required. In these scenarios, classifying hiatal hernias by Hill grade to determine the correct course of treatment is important, noting that Hill grade 4 is easy to identify. It’s the Hill grade 2s and 3s where more attention is required for bettering classification to determine if the patient can benefit from the TIF procedure. A patient with a Hill grade 2 has a shorter valve that with inspiration creates a lip forming an identifiable “respiratory smile.” Dr. Abu Dayyeh asserts that for these patients TIF corrects the physiological defect in this valve by creating a three-centimeter lip valve, a high-pressure area of 270 degrees in the optimum position at the GE-Junction. For moderate to severe anatomical defects, with an easily identifiable Hill grade 4, surgical correction of the hiatal hernia will be warranted, but this could be addressed concomitantly with TIF.

Why TIF procedure? Why Now? Evolution, updated device, current data, patient selection Kenneth J. Chang, M.D.

Dr. Chang opens by emphasizing that TIF, which is essentially an endoscopic fundoplication, satisfies a great need for an anatomical procedure that’s non-surgical to address GERD, especially in the face of increasing literature citing concerns over the long-term use of PPIs. Dr. Chang then walks the audience through both the mechanics of the TIF procedure and the components and evolution of the Esophyx® device, since he started working with it in 2006. He uses video footage to walk through the highlights of an actual TIF procedure, providing useful, practical tips. Dr. Chang then examines the evolution of TIF, starting with the ELF procedure in Europe, through TIF 1 and today’s TIF 2 treatment, where the high-pressure zone is similar to a Nissen fundoplication. In fact, for hiatal hernias of less than 2 centimeters, TIF provides all the benefits of a Nissen, and for hernias greater than 2 centimeters, the hernia can be surgically repaired concomitantly with TIF.

Dr. Chang then summarizes highlights from related literature over the past 8 years as well as recent studies, concluding that TIF provides durable long-term control of regurgitation, heartburn, and atypical symptoms post-procedure in a subset of chronic GERD patients with small hiatal hernias. TIF is now a proven endoscopic alternative to control troublesome GERD symptoms in well-selected patients on prior maximal dose PPIs. It is now considered an alternative treatment in a subset of GERD patients to fundoplication. The expanded label includes combining the laparoscopic hernia repair concomitantly with TIF.

Hiatal Hernia Repair and Concomitant Transoral Fundoplication Peter G. Janu, M.D.

Dr. Peter Janu from Appleton and Chilton, Wisconsin, talks about hiatal hernia repair, concomitant with TIF procedure. He opens by pointing out that with the subset of patients with reflux that’s on medical therapy, about 30% to 40% of those patients aren’t satisfied with how those medications are treating them, and less than 1% are actually undergoing any type of surgical intervention. Dr. Janu provides an overview of the anatomy of the diaphragmatic hiatus in conjunction with the proper angles at the GE-junction and the fundus, which normally are supposed to provide a barrier, but just like any other moving part in the body, can wear down over time.

Dr. Janu recounts how traditionally, patients could undergo a laparoscopic Nissen fundoplication, with a 360-degree wrap, re-creating the desired high-pressure zone, but essentially acting only as a one-way valve resulting in side-effects such as bloating and dysphagia. He says, an endoscopic TIF significantly reduces these symptoms by creating a 270-degree-wrap for a hiatal hernia of less than 2 centimeters. For a hiatal hernia greater than 2 centimeters, Dr. Janu describes working with Dr. Peter Mavrelis, a Gastroenterologist out of Northwest Indiana, to surgically address the hiatal hernia and then concomitantly proceed with TIF, which has proven safer and more effective than a traditional laparoscopic Nissen. This assertion is affirmed by studying a cohort of 99 patients who had a hiatal hernia repair laparoscopically followed concomitantly by TIF and checking in with each patient at 6-month and 12-month intervals after their operation. Significant improvement in all metrics measuring the patient’s quality of life was displayed. Dr. Janu concludes with a warning that care must be taken when measuring the Hill grade of the hiatal hernia, as often a Hill grade 3 can appear smaller when viewed endoscopically.

Panel of Experts Discuss GERD Management & TIF Procedure at DDW

View the full program of Digestive Disease Week (DDW) November 30, 2018, in Washington, DC, to see each of the panel segments shown above in their full context. After their individual presentations, the panel of experts fielded questions from a well-informed audience of attendees, ranging from applications to patients with achalasia status post or myotomy, to increasing the effectiveness rate even higher, into the 95-100% range following a TIF, to the applicability of TIF with a sleeve gastrectomy and a recreated a de novo reflux, to issues of unintentional selective vagotomy for patients who are off PPIs and to TIF redos and Nissen repair.


About GERD
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.

About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.

Over 25,000 TIF procedures have been performed worldwide. More than 140 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit

About Reimbursement
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.

For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.

About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.

The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.

About EndoGastric Solutions®
Based in Redmond, Washington, EndoGastric Solutions, Inc. (, is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.

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Ted Stephens
EndoGastric Solutions, Inc.
Phone: +1 513-312-9161

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867