REDMOND, Wash.--(BUSINESS WIRE)--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), announced today that the American Gastroenterological Association (AGA) has issued a Technology Coverage Statement on Minimally Invasive Surgical Options for GERD (http://www.gastro.org/practice-management/reimbursement/aga-technology-coverage-statements).
Randomized controlled trial data from Transoral incisionless fundoplication (TIF®) performed using the EndoGastric Solutions’ EsophyX® device system was in the AGA Statement cited.
The AGA Statement addresses transoral fundoplication for the management of patients with GERD. The key points are:
- Recognizing that the AGA medical position statement on the management of GERD has not been updated since 2008, AGA convened a multi‐disciplinary workgroup to develop a framework for selected services and procedures related to the diagnosis and treatment of GERD.
- The goal of GERD therapy is to control both the symptoms and mucosal damage.
- This procedure [transoral fundoplication] delivers patient outcomes similar to those provided by conventional antireflux surgery (ARS) procedures and does not limit future treatment options.
- In conclusion, the three‐year plus evidence [for the TIF procedure] is sufficient to demonstrate sustainable improvement in health outcomes, symptom relief, decrease in PPI utilization and improvement in esophageal pH with transoral fundoplication.
- Transoral fundoplication should be covered and reimbursed for appropriate patients who meet the selection criteria as described.
“This demonstrates key society support for the TIF procedure as an anti-reflux procedure option for chronic GERD suffers,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We are grateful to the AGA and its panel of experts to issue such a review in advance of updates to existing society guidelines.”
“This statement by the AGA is important for advocacy work with payers,” said Philip Macdonald, Vice President, Healthcare Economics, Policy & Reimbursement. “Publishing new guidelines can be time consuming and cost prohibitive. The evolution of data-proven technologies to treat chronic diseases is accelerating so the Technology Coverage Statement by the AGA can help fill the gap during the society’s guideline review cycle. This ensures society membership is able to provide safe and effective treatments for chronic disease sufferers sooner.”
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 registered trademark of the American Medical Association.
The Federal Register has posted coding and payment information specific to the new 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 as of January 1, 2016.
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. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.
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 people at least once per month in the U.S. 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 another 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 PPI medications to control symptoms.
Over 18,000 TIF patients have been treated worldwide since the EsophyX® device was launched. More than 70 peer-review papers from over 50 centers have been published documenting consistent outcomes on over 1,100 unique study patients. For more information, visit www.GERDHelp.com.
About EsophyX® technology
The original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z, in 2015. The technology has continued to evolve and is a clinically-backed tool for physician use in the treatment of GERD. The 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. 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.
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®) procedure—a minimally invasive solution that addresses a significant unmet clinical need.
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI 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.