Long-Term Outcomes from TIF US Registry Presented at 2013 SAGES Annual Meeting

REDWOOD CITY, Calif.– EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for Gastroesophageal Reflux Disease (GERD), today announced the presentation of two year data from the Transoral Incisionless Fundoplication (TIF®) US Registry at the 2013 SAGES Annual Meeting during the therapeutic endoscopy scientific session in Baltimore, Maryland.

The TIF procedure was safe and effective in eliminating or improving a range of typical and atypical GERD symptoms, including heartburn and reflux, in up to 81% of patients in the study. Also, in 81% of patients undergoing endoscopy 24-months after their TIF procedure, esophagitis was fully healed or notably improved.

“This two year data demonstrates the long-term value of a transoral anatomic correction in the treatment of GERD patients with mild to moderate disease. We are very encouraged by the sustained response seen by patients with either typical or atypical symptoms,” said Mike Kleine, President and CEO of EGS.

Twenty-four months after the EsophyX2® device was used in TIF procedures, more than two-thirds of patients completely eliminated the need for daily proton pump inhibitor (PPIs) therapy. Symptom control achieved at six months remained stable over time indicating durability of TIF procedure.

“The TIF procedure is an attractive option because it dramatically shifts the risk-benefit ratio associated with correcting the underlying anatomical defect and allows a majority of patients to stop taking daily medication for reflux,” said Karim Trad, MD, FACS, SAGES presenter and an investigator in this prospective multicenter registry of patients with chronic GERD.

The risks associated with medical management of GERD patients for years or decades are becoming more evident. Traditional surgical interventions for GERD have historically been reserved for patients with the most severe disease. However, most patients have been unwilling to accept the well documented side effects of difficulty swallowing and gas bloat associated with traditional surgery. In stark contrast, the TIF procedure offers an alternative option to select GERD patients because almost none of these side effects occurred in the TIF registry population.

The TIF procedure was also highlighted during these SAGES sessions:

  • Reginald Bell, M.D., of Swedish Medical Center, presented “Emerging Technologies and Techniques” during the Postgraduate Course Foregut Beyond GERD and Hiatal Hernia Wednesday April 17
  • Erik Wilson, M.D., of Memorial Hermann Healthcare, presented “Transoral Incisionless Fundoplication (TIF), is the procedure here to stay?” during the Postgraduate Course Endoluminal Treatments – GERD and POEM Thursday April 18
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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.

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 and LinkedIn: EndoGastric Solutions.

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Contact:
Ted Stephens
EndoGastric Solutions, Inc.
Phone: +1 513-312-9161
tstephens@endogastricsolutions.com

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