Dr. Simoni of Advanced GI Inc. in Thousand Oaks, California is featured in this webinar, broken down into pivotal segments. Since his initial procedures in 2009, Dr. Simoni has extensive experience, including TIF procedures that were included in both the TEMPO and the US registry clinical studies. He is one of the first interventional gastroenterologists in the United States to integrate the TIF procedure in his practice, and remarkably, he has always been very supportive and acknowledged the importance of concomitant procedures, repairing the hiatal hernia before a TIF procedure. He has worked side-by-side with several general surgeons, who laparoscopically repair the hiatal hernia before he performs the TIF 2.0 procedure with the EsophyX® device.

Webinar Highlights

Webinar Series: Gastroesophageal valve anatomy. Gilbert Simoni, MD Advanced Gastroenterology, Thousand Oaks, CA

Dr. Simoni opens with a slide of the anatomy of the gastroesophageal valve (GEV) explaining and highlighting the three components: the intrinsic, which is smooth muscle; the extrinsic, which is the striated muscles of the crura; as well as the phrenoesophageal ligament. Disruption of any of these compartments can lead to gastroesophageal reflux disease (GERD). He then explains how, even if you have a normal-looking anatomy, you can still have gastroesophageal reflux disease, and the more abnormality you have in your anatomical structures, the more severe GERD you’re going to have. This notion is supported in a 2013 study by Shahin and DeMeester at DDW. What is staggering here is that about half of those patients, 406 patients, had a normal-looking lower esophageal sphincter, but they had an abnormal DeMeester score (the level of acid reflux). The second observation here was that as you had more and more components being affected, you had more and more reflux. Dr. Simoni emphasizes that the earliest issue with gastroesophageal reflux disease is the dynamic failure of the lower esophageal sphincter. You do not have to have a huge hiatal hernia to have acid reflux. You can have a normal-looking valve, and still have significant reflux and symptomatic reflux. He affirms that GERD is a clinically progressive disease and that we need to recognize the early stages and mild symptoms. Giving patients PPIs puts a bandaid on their symptoms, because as time goes on, if we do not correct the actual problem, patients will eventually develop complications, some of which can be irreversible.

Webinar Series: Expanded Indication for TIF procedure. Gilbert Simoni, MD Advanced Gastroenterology, Thousand Oaks, CA

In this segment of the webinar, Dr. Simoni expands on an earlier slide provided by EndoGastric Solutions indicating that there are a significant number of patients who have uncontrolled reflux, and not a lot of them are given options for surgical treatment. That’s partially because of the prior experience of primary care physicians and GIs, having had patients post-Nissen experiencing significant dyspepsia, and an inability to vomit. However, after June 2017 the indication for a TIF procedure was expanded to be able to correct even larger anatomical defects. Equally, early disease can also have non-anatomic causes, or have a normal lower esophageal sphincter. Physicians should be able to offer these patients the possibility of a TIF procedure, and give them an option to correct their reflux, therefore providing significant relief and preventing any further complications.

In the evolution of the procedure to its present form, TIF 2.0 is essentially the same as Nissen for manometric appearance and very similar to a high-pressure zone. The TIF procedure has almost the same technical aspects of anti-reflux surgery, laparoscopic-type fundoplication, but should be one of the first lines in the surgical treatments for gastroesophageal reflux disease. TIF resolves patients’ symptoms off PPIs. There are no de novo dysphasia, bloating, or flatulence reported with TIF procedures. As a matter of fact, patients that did have baseline dysphasia and bloating got better. The other aspect here is that you can use TIF to fix a failed Nissen and if you have another anti-reflux surgery, TIF is not going to affect your lower esophageal area or the area of your hiatal hernia, or result in significant surgical complications.

Webinar Series: Selecting patients for concomitant procedures. Gilbert Simoni, MD Advanced Gastroenterology, Thousand Oaks, CA

Dr. Simoni concludes by answering a common question among surgeons: “So why do I have to come in and do your hernia repair when it takes me another few minutes to just wrap the stomach?” Dr. Simoni gives two reasons: first, there are no de novo side effects or post-Nissen fundoplication issues following a TIF procedure. Second, when you do a Nissen fundoplication, your stomach is not distended, so you can’t really see how tight or how loose the valve is going to be. Therefore, the best way to recreate the lower esophageal sphincter is to endoscopically visualize it through a TIF procedure.

Finally, Dr. Simoni provides an executive summary highlighting the transparency of EGS as one of the few device companies that base their success on patient outcomes. The evidence behind the TIF procedure is very solid, with 80 peer-reviewed papers in both surgical and GI publications, on 1,500 unique patients. More than 22,000 patients have had the TIF procedure since 2007, by both surgeons and gastroenterologists, with significant improvement over the years. Numerous randomized clinical trials have proven TIF to be highly effective and durable, providing consistent improvement, and TIF is extremely safe, with less than 0.5 percent significant adversity events, further re-enforcing Dr. Simoni’s position that TIF should be one of the first lines of endosurgical treatments for gastroesophageal reflux disease.

Dr. Gilbert Simoni Webinar on GERD Work-up and TIF Patient Selection

View the full webinar below, to see each of the highlighted segments, in their context, from Dr. Gilbert Simoni, MD, Advanced GI Inc. Thousand Oaks, California, He is one of the first interventional gastroenterologists in the United States to fully adopt the TIF procedure in his practice, and an early adopter of the notion of concomitant procedures, repairing the hiatal hernia before a TIF procedure. After his presentation, Dr. Simoni takes questions from the audience, such as “How much time do you spend evaluating the hiatal hernia during the endoscopy?” adding his recommendations for doing a concomitant repair with TIF if the hiatal hernia is more than 2cm. Dr. Simoni talks about informing patients unfamiliar with TIF about the procedure, and options for follow-up. He discusses chronic gastric distension from gastric balloons and how this might make GERD worse, and the need for the public to be educated about TIF as a frontline option for successfully and safely treating GERD.


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 www.GERDHelp.com.

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. (www.endogastricsolutions.com), 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