TIF procedure patients experienced similar reduction in reflux symptom resolution with significantly reduced operative times compared to Nissen or Toupet fundoplication techniques

SAN MATEO, Calif. (Sept 3, 2014)–EndoGastric Solutions® (EGS), a leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), announced publication of an independent study entitled Transoral Incisionless Fundoplication: Is It as Safe and Efficacious as a Nissen or Toupet Fundoplication? The study demonstrated that transoral incisionless fundoplication (TIF) provides dramatic symptom resolution, similar to that achieved after laparoscopic Nissen or Toupet fundoplication.

In each of the treatment arms, most patients experienced GERD symptoms less than once per month—after TIF procedure 83%, after Nissen 80%, and after Toupet 92%. Operative times were significantly shorter with the TIF procedures averaging 71 minutes vs 119 minutes for Toupet and 85 minutes for Nissen. In addition, length of postoperative hospital stay was significantly shorter after the TIF procedure.

“The TIF procedure is safe and effective in relieving excess gastroesophageal reflux symptoms,” said Alexander Rosemurgy, MD, Florida Hospital Tampa “In our patient series, the TIF procedure provided added benefits of shorter recovery times, and is the most minimally invasive option for symptomatic reflux patients.”

The authors concluded, “Patient satisfaction and effective palliation of symptoms prove that the TIF procedure is safe and efficacious in comparison to LESS Nissen and Toupet fundoplication surgeries, and we offer strong support for its continued application and evaluation.”

“Having new data published independently comparing our TIF procedure to the current standard of careis another important milestone for EGS, and adds to the growing body of clinical evidence surrounding our technology,” said Skip Baldino, EGS President and CEO. “It is significant for GERD patients needing a less invasive option, that the TIF procedure outcomes have been clinically validated to be similar to traditional surgery.”

The results were published in the September issue of the American Surgeon, the official journal of the Southeastern Surgical Congress and the Southern California Chapter of the American College of Surgeons. This data is from a case controlled study of three cohorts, each with 20 patients—TIF procedure, laparoscopic Nissen and Toupet fundoplication—that were controlled for age, BMI, and pH scores. Abstract is available here.

NP02423-01A

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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