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EndoGastric Solutions’ TIF 2.0 Procedure Highlighted in Multiple Sessions at DDW 2019

11:00 EDT 9 May 2019 | Businesswire

EGS to host DDW Product Theater session showcasing the evolution of TIF 2.0 procedure along with updates on concomitant hiatal hernia repair

EndoGastric Solutions® today announced that new data on the Transoral Incisionless Fundoplication (TIF® 2.0) procedure will be presented during multiple sessions at Digestive Disease Week® (DDW®) 2019. These data add to the robust set of published studies demonstrating the effectiveness of the TIF 2.0 procedure performed with or without laparoscopic hiatal hernia repair in treating gastroesophageal reflux disease (GERD). DDW, the world's largest gathering of physicians, researchers and industry leaders in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, takes place in San Diego, May 18 - 21, 2019.

“We are pleased to have multiple opportunities to share incremental clinical findings underscoring the efficacy of TIF 2.0 and the high level of patient satisfaction for the TIF 2.0 procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “TIF 2.0 addresses an unmet clinical need for patients suffering from GERD. The ability to perform TIF 2.0 safely with concomitant laparoscopic hiatal hernia repair increases the number of patients who now can achieve long-term relief of their GERD symptoms.”

“TIF 2.0 addresses an unmet clinical need for patients suffering from GERD. The ability to perform TIF 2.0 safely with concomitant laparoscopic hiatal hernia repair increases the number of patients who now can achieve long-term relief of their GERD symptoms.” - Skip Baldino, President and CEO of EndoGastric Solutions
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The TIF 2.0 procedure is a minimally invasive endoscopic intervention performed with the EsophyX® device, which enables anatomical correction of the gastroesophageal valve without the resulting complications associated with traditional fundoplication. This approach provides an effective treatment option for patients seeking an alternative to traditional, more invasive surgical treatment options. For patients with hiatal defects of two centimeters or more, new data reiterate the conclusion that a concomitant hiatal hernia repair and TIF 2.0 procedure improves objective and subjective assessment of GERD symptoms.1

The TIF 2.0 procedure will be featured in the following sessions at DDW 2019:2

Podium Presentation – New Technology Endoscopic Advancements Session
719: Efficacy and Patient Satisfaction of Single-Session Intraoperative Transoral Incisionless Fundoplication and Laparoscopic Hernia Repair (ASGE). Monday, May 20, 3:00 p.m. – 3:15 p.m., Room 6C. Presented by: Viktor E. Eysselein, MD, Harbor UCLA Medical Foundation, California.

Poster Presentation – Esophagus 1 Session
Mo1229: Transoral Incisionless Fundoplication (TIF) To The Rescue: Is TIF The Answer To Post-POEM Gerd? Monday, May 20, 12:00 p.m. – 2:00 p.m., Halls C-E. Presented by: Olaya I. Brewer Gutierrez, Johns Hopkins Hospital, Maryland.3

Poster Presentation – New Technology Session
Tu2020: Transoral Incisionless Fundoplication: Effectiveness in Improving Typical and Atypical Symptoms of Gastroesophageal Reflux Disease Incompletely Controlled with Medical Therapy (ASGE). Tuesday, May 21, 12:00 p.m. – 2:00 p.m., Halls C-E. Presented by Amit Sohagia, MD, Easton Hospital, Pennsylvania.

DDW Product Theater – Shaping the Future of GERD
EndoGastric Solutions is sponsoring a symposium at DDW 2019 titled “Shaping the Future of GERD” from 11:30 a.m. to 12:05 p.m. on Sunday, May 19, in the DDW Product Theater 1. During this session, faculty will present an overview of data surrounding the evolution of the TIF 2.0 procedure, including pH control, concomitant use following hiatal hernia repair, and endoscopic treatment of foregut diseases. Faculty members include:

  • Barham Abu Dayyeh, MD, MPH, FASGE, Mayo Clinic, Rochester, Minnesota
  • Glenn Ihde, MD, Matagorda Medical Group, Bay City, Texas
  • Kenneth Chang, MD, FACG, FASGE, UCI School of Medicine, Irvine, California

The American Society for Gastrointestinal Endoscopy (ASGE) Special Interest Group Meeting
Endoluminal Therapy for Esophageal Disease and Gastroesophageal Reflux Disease (ETED/GERD SIG) will be held during DDW on Monday, May 20, from 10 a.m. to 11:30 a.m. in Ballroom B. During the session, faculty will review endoscopic options for patients with esophageal motility disorders, GERD, Barrett's esophagus and esophageal cancer.

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 22,000 TIF procedures have been performed worldwide. More than 100 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.

Indications

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, EndoGastricSolutions and LinkedIn: EndoGastricSolutions.

_____________________________

1 Ihde GM, Pena C, Scitern C, Brewer S. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS. 2019;23(1):e2018.00087

2 All data presented at DDW are embargoed for the beginning of its presentation time or an official DDW press conference, whichever occurs first
3 Small investigator initiated study of early experience treating GERD Post-POEM; larger prospective studies are still needed

Debbie Donovan
EndoGastric Solutions, Inc.
Phone: +1 408-621-0216
ddonovan@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com

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