EndoGastric Solutions® (EGS), a leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), announced publication of an independent study entitled Transoral Incisionless Fundoplication: Is It as Safe and Efficacious as a Nissen or Toupet Fundoplication? The study demonstrated that transoral incisionless fundoplication (TIF) provides dramatic symptom resolution, similar to that achieved after laparoscopic Nissen or Toupet fundoplication.
"It is significant for GERD patients needing a less invasive option, that the TIF procedure outcomes have been clinically validated to be similar to traditional surgery."
In each of the treatment arms, most patients experienced GERD symptoms less than once per month - after TIF procedure 83%, after Nissen 80%, and after Toupet 92%. Operative times were significantly shorter with the TIF procedures averaging 71 minutes vs 119 minutes for Toupet and 85 minutes for Nissen. In addition, length of postoperative hospital stay was significantly shorter after the TIF procedure.
"The TIF procedure is safe and effective in relieving excess gastroesophageal reflux symptoms," said Alexander Rosemurgy, MD, Florida Hospital Tampa. "In our patient series, the TIF procedure provided added benefits of shorter recovery times, and is the most minimally invasive option for symptomatic reflux patients."
The authors concluded, "Patient satisfaction and effective palliation of symptoms prove that the TIF procedure is safe and efficacious in comparison to LESS Nissen and Toupet fundoplication surgeries, and we offer strong support for its continued application and evaluation."
"Having new data published independently comparing our TIF procedure to the current standard of care is another important milestone for EGS, and adds to the growing body of clinical evidence surrounding our technology," said Skip Baldino, EGS President and CEO. "It is significant for GERD patients needing a less invasive option, that the TIF procedure outcomes have been clinically validated to be similar to traditional surgery."
The results were published in the the American Surgeon, the official journal of the Southeastern Surgical Congress and the Southern California Chapter of the American College of Surgeons. This data is from a case controlled study of three cohorts, each with 20 patients - TIF procedure, laparoscopic Nissen and Toupet fundoplication - that were controlled for age, BMI, and pH scores.
Gastroesophageal Reflux Disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to wash back up 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 compose 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 23 million people two or more times per week 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 the EsophyX® device
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted through the patient's mouth with visual guidance from an endoscope, the EsophyX device is used to reconstruct the gastroesophageal valve (GEV) in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
Performed entirely through the mouth without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery. 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.
The TIF procedure has an established safety and efficacy profile with more than 15,500 patients treated worldwide. For more information, visit www.GERDHelp.com.