REDMOND, Wash--(BUSINESS WIRE)--EndoGastric® Solutions today announced the publication of a meta-analysis supporting the clinical utility of Transoral Incisionless Fundoplication (TIF®) 2.0 in the treatment of refractory gastroesophageal reflux disease (GERD). The TIF 2.0 procedure is a minimally invasive endoscopic option that enables anatomical correction of the gastric valve without incisions or complications associated with laparoscopic surgical fundoplication. The publication, Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials, was published in the March/April issue of Chirugia (Surgery).
This publication is a meta-analysis of three randomized clinical trials comprising of 223 patients with chronic long-term refractory GERD on optimized PPI therapy and is the first published Evidence Level Ia study comparing TIF 2.0 procedure with PPI therapy and sham endoscopy with or without PPI therapy. The analysis suggests that the TIF 2.0 is a durable, effective procedure that controls symptoms and allows patients to discontinue PPI use at rates similar to traditional surgical techniques with improved safety profile and fewer long-term side-effects.
“Given the potential side-effects associated with long-term PPI dependency and the known adverse events of traditional surgical options, validated treatment options are urgently needed to treat the 19 million daily reflux sufferers,” said Nirav Thosani, MD, MHA, Director of Advanced Endoscopy, Ertan Digestive Disease Center, Memorial Hermann Hospital, Texas Medical Center. “The TIF 2.0 procedure provides an alternative option for patients who want to eliminate or reduce medical therapy and do not want to undergo traditional surgery.
“We are extremely pleased to see a growing body of clinical data supporting both clinical and quality of life benefits associated with the TIF 2.0 procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “However, our excitement about this new analysis is tempered by our sadness for the loss of Dr. Laura Gerson, lead author on the publication, who passed away last year. Dr. Gerson was a dedicated clinician and researcher, and we hope this final meta-analysis will serve as a testament to the numerous substantive contributions she made to advancing the care and outcomes of patients with gastrointestinal disorders.”
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. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendations for GERD patients is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are instructed to take medications—proton pump inhibitors; unfortunately, it is a common practice to increase medication doses and, over time, become dependent on these medications to control symptoms. A variety of other health complications are linked to the long-term, maximum-dose dependency on PPIs.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
A minimally invasive endoscopic treatment, performed without the need for external incisions through the skin, the TIF 2.0 procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stopped using daily medications to control symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF procedure based on studies.
There have been more than 20,000 TIF patients treated worldwide since the EsophyX® device launched. In the past ten years, over 60 centers published more than 80 peer-reviewed papers. These studies document consistent outcomes on over 1,300 unique study patients. For more information, visit www.GERDHelp.com.
Commercial and federal insurance providers, representing over 100 million lives, have recognized the value of the TIF procedure through recently expanded contract and coverage reimbursement. EndoGastric Solutions has confirmed coverage for all Medicare enrollees through Medicare Administrative Contractors (MACs)—CGS, First Coast, NGS, Noridian, Novitas, Palmetto, WPS.
Annually, the Federal Register posts unadjusted average payments specific to the CPT® code for physicians and hospital Ambulatory Payment Codes (APC), allowing patients to receive access to treatment more easily for GERD. For the TIF procedure, physicians can reference CPT Code 43210 EGD esophagogastric fundoplasty and hospitals can reference APC 5362 Level 2 Laparoscopy Procedures. CPT is 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 refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The U.S. Food and Drug Administration cleared the original EsophyX device 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 to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.
The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are 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 ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
About EndoGastric Solutions®
Based in Redmond, WA, 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 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: GERDHelp and Google+: GERDHelp, LinkedIn: EndoGastric Solutions.