REDMOND, Wash.--(BUSINESS WIRE)--EndoGastric® Solutions today announced the publication of new clinical data demonstrating the safety and efficacy of the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure in patients with achalasia who have undergone Peroral Endoscopic Myotomy (POEM). The TIF 2.0 procedure is a minimally invasive procedure that enables physicians to perform an endoscopic gastric fundoplication.
This study, titled, “Transoral Incisionless Fundoplication for reflux after peroral endoscopic myotomy: a crucial addition to our arsenal” appeared in the May issue of Endoscopy International Open.
Achalasia is a gastroesophageal disorder that causes patients to have difficulty swallowing. Patients may also experience chest pain and regurgitation of food and liquids. The POEM procedure is effective in more than 90% of achalasia patients, but the reduction in lower esophageal sphincter pressure that addresses achalasia symptoms can give rise to increased acid exposure and gastroesophageal reflux disease (GERD) which is associated with an increased prevalence of Barrett’s Esophagus and esophageal cancer.
Many patients often require long-term therapy with proton pump inhibitors (PPI) to address their GERD symptoms following the POEM procedure; however long-term PPI use is associated with several negative side-effects which include increased risk of developing depression, dementia, chronic kidney disease, gastrointestinal infections and vitamin and mineral deficiencies.
“POEM is now clearly established as an effective therapy for achalasia, but it may lead to increased esophageal acid exposure which can be associated with significant long-term health effects,” said Amy Tyberg, MD, Associate Director of Endoscopy at Rutgers Robert Wood Johnson Medical School, Rutgers, New Brunswick, NJ. “There is a robust and growing data set supporting the TIF 2.0 procedure as a durable and safe approach to treating chronic GERD, and the results of this study demonstrate that it can also provide clinical benefit as a minimally invasive intervention following POEM. These findings are an important advance in the care of achalasia patients who are status post POEM, some of whom trade in symptoms of dysphagia for symptoms of GERD.”
Tyberg continued, “In a recently published meta-analysis, Repici et al. concluded that for achalasia patients, performing myomectomy (laparoscopically or endoscopically) and then a staged antireflux procedure to control GERD symptoms may increase efficacy when treating this challenging condition.”1
This study, the first case series evaluating the role of the TIF procedure in the management of GERD post-POEM, was conducted in five consecutive patients 18 years of age or older who underwent POEM and subsequent TIF procedures at a single center between December 2014 and June 2017. The average time between POEM and TIF procedures was 13.5 months (range 4 – 27 months).
Patients enrolled in the study had achieved complete or partial relief of their GERD symptoms with PPIs. Three patients entered the study with esophagitis. The TIF procedure was performed with the EsophyX® Z model device. The primary outcome was discontinuation of PPI use and healing of esophagitis in those patients in which this condition was present at the time of the TIF procedure. At mean follow up of 27 months (range 5 – 34 months) key study findings include:
- Technical success of the TIF procedure was achieved in all five patients.
- Complete discontinuation of PPI use was achieved in all five patients (100%).
- The three patients with esophagitis saw resolution of inflammation three months following the TIF procedure.
- There were no adverse events.
“These findings support the TIF 2.0 procedure with the EsophyX device as an effective and safe treatment in patients who develop GERD following POEM,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We hope that these results will encourage physicians to consider this approach as they treat post-POEM achalasia patients.”
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. 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.
About Reimbursement
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.
Indications
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.
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1 Repici A, et Al., Send to Gastrointest Endosc. 2018 Apr;87(4):934-943.e18. doi: 10.1016/j.gie.2017.10.022.
