Study participants saw 80 percent improvement for heartburn and regurgitation one-year post procedure when hiatal hernia and gastroesophageal valve were repaired sequentially
REDMOND, Wash. – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced the presentation of data from the Transoral Incisionless Fundoplication (TIF ®) 2.0 procedure using the EsophyX® device after hiatal hernia repair (HHR) in patients with chronic GERD symptoms. The study evaluated the symptom resolution, safety, patient satisfaction and efficacy of this approach. The prospective study data will be presented at the American College of Gastroenterology (ACG) 2017 Annual Scientific Meeting, October 13-18, 2017 in Orlando, Florida.
Ninety-nine patients with a confirmed diagnosis of GERD symptoms at two community-based hospitals underwent the TIF 2.0 procedure immediately following a laparoscopic HHR in the same anesthetic session. All participants enrolled were symptomatic on proton pump inhibitor (PPI) medications with hiatal hernias between 2 and 5 centimeters.
Overall, the study met the primary efficacy and safety endpoints with no treatment-related adverse events, concluding that TIF 2.0 procedures can be safely and efficiently performed immediately following HHR. The study also met the secondary endpoints, with most patients reporting 80 percent improvement for heartburn and regurgitation and more than 50 percent improvement for bloating and dysphagia.
“While some patients may experience temporary relief from PPI medications, this study offers substantial evidence that HHR-TIF 2.0 procedures can provide lasting relief from chronic GERD symptoms, and improve patients’ quality of life,” said Peter Janu, M.D. of Wisconsin. “Our symptomatic outcomes confirm the excellent safety profile and the effectiveness of this combination procedure up to one year despite the initial larger hiatal hernia.”
The study data authored by Peter Janu, MD and Peter Mavrelis, MD, et Al., will be displayed as a poster on Tuesday, October 17, 10:30 a.m. to 4:30 p.m. ET in the Exhibit Hall.
“Findings from the prospective study support HHR-TIF 2.0 procedures as a potential new option for patients suffering from hiatal hernias greater than 2 centimeters,” said Peter Mavrelis, MD of Indiana. “We are excited to share these results and build upon the robust clinical data supporting the TIF 2.0 procedure as a durable treatment option for patient suffering from GERD.”
On June 22, 2017, EGS received notification from the U.S. Food and Drug Administration following 501(k) submission to expand the indication for the EsophyX device to include patients with hiatal hernias larger than 2 centimeters when a laparoscopic hiatal hernia repair (HHR) reduces the hernia to 2 centimeters or less.
“EndoGastric Solutions would like to congratulate the lead investigators, Drs. Janu and Mavrelis, for publishing a very important study,” said Skip Baldino, President and CEO, EndoGastric Solutions. “This compelling data and the FDA’s expanded label indication, will provide millions of patients access to a durable and effective solution to treat chronic symptoms of GERD.”
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.
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 22,000 TIF procedures have been performed worldwide. More than 100 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.
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.
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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