EndoGastric Solutions Release: SAGES Clinical Spotlight Review Gives “Strong Recommendation” To EsophyX Device Used In TIF 2.0 Procedure

REDMOND, Wash.--(BUSINESS WIRE)--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), is pleased to announce that based on clinical evidence, the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) included a “strong recommendation” in favor of EsophyX® device used in Transoral Incisionless Fundoplication (TIF®) 2.0 procedure in their published “Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal Reflux Disease.”

“The publication of this Clinical Spotlight Review demonstrates SAGES’ interest in keeping current with evidence of less intrusive anti-reflux procedures that meet high thresholds of safety and efficacy as demonstrated through peer-reviewed publications”

“Based on existing evidence, TIF [2.0 procedure] can be performed with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GERD symptoms compared with PPI treatment…. Objective GERD measures improve similarly after TIF 2.0 [procedure] compared with PPI,” according to the report released by the organization.

“The publication of this Clinical Spotlight Review demonstrates SAGES’ interest in keeping current with evidence of less intrusive anti-reflux procedures that meet high thresholds of safety and efficacy as demonstrated through peer-reviewed publications,” says Skip Baldino, CEO, EndoGastric Solutions. “Clinical society reviews and updates of treatment guidelines are essential to providing guidance to members and payers for managing chronic diseases such as GERD.”

EGS will demonstrate the TIF procedure using the EsophyX Z device at SAGES Exhibit Hall booth #808 March 22-24, 2017 in Houston, TX.

In October 2016, Surgical Endoscopy, the official journal of SAGES, published online first three-year follow up data from TIF EsophyX vs Medical PPI Open Label (TEMPO), a prospective, randomized, multicenter clinical study, which demonstrated long-term control of chronic GERD after a TIF 2.0 procedure with the EsophyX® device. The study met its primary endpoint, with 83 percent of patients undergoing the TIF procedure experiencing elimination of regurgitation and all atypical GERD symptoms at three-years post-procedure. The open access paper is available at GERDHelp.com.

“In 2014, SAGES leadership played a pivotal role in an unprecedented unification with the gastroenterology societies—AGA, ACG, ASGE—to support the application for Category 1 CPT® code 43210 EGD: Esophagogastric Fundoplasty. Due to the collective societies’ efforts, the code went into effect January 1, 2016, and this has increased patient access to the TIF procedure as a treatment for their GERD symptoms,” continued Baldino.

In 2016, SAGES was also active in supporting a positive coverage decision from Health Care Service Corporation (HCSC) which is responsible for approximately 15 million members through its affiliates—Blue Cross Blue Shield of Illinois, Blue Cross Blue Shield of Montana, Blue Cross Blue Shield of New Mexico, Blue Cross Blue Shield of Oklahoma and Blue Cross Blue Shield of Texas.

To date, the TIF procedure has confirmed coverage with these Medicare Administrator Contractors: Palmetto GBA, LLC for over 4.4 million members in North Carolina, South Carolina, Virginia and West Virginia; Cahaba Government Benefit Administrators®, LLC for over three million members in Alabama, Georgia and Tennessee; CGS Administrators®, LLC which serves 2.4 million members in Kentucky and Ohio; and Novitas Solutions, Inc. which covers over nine million members in Arkansas, Colorado, Louisiana, Mississippi, New Mexico and Oklahoma.

About Current Procedural Terminology (CPT®)

CPT codes are a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients and third parties. CPT is a registered trademark of the American Medical Association.

The Federal Register has posted coding and payment information specific to the CPT code, allowing patients to more easily receive access to treatment for GERD. Physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures for TIF® procedures.

About GERD

Gastroesophageal reflux disease (GERD) 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. GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 80 million Americans at least once per month. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g., diet, scheduled eating times and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum-dose usage of prescription medications has been linked to a variety of other health complications.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure, esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily medications to control symptoms.

More than 18,000 TIF patients have been treated worldwide since the EsophyX® device was launched. In the past ten years, more than 70 peer-reviewed papers from over 50 centers have been published documenting consistent outcomes on over 1,200 unique study patients. For more information, visit www.GERDHelp.com.

About EsophyX® technology

The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The original EsophyX device was cleared by the U.S. Food and Drug Administration in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes – including low profile and larger high-definition models — to treat the underlying anatomical cause of GERD.

Indications

The EsophyX device with SerosaFuse® fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract and is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia = 2cm in size in patients with symptomatic chronic GERD.

About EndoGastric Solutions®

Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company focused on 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 the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp, Facebook: GERDHelpcom and Google+: GERDHelp.