Newly-Published 8-Year Follow-Up Study Confirms the Safety, Efficacy, and Durability of Stretta in GERD Treatment - Applied Clinical Trials

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Newly-Published 8-Year Follow-Up Study Confirms the Safety, Efficacy, and Durability of Stretta in GERD Treatment


Newly-Published 8-Year Follow-Up Study Confirms the Safety, Efficacy, and Durability of Stretta in GERD Treatment

PR Newswire

NORWALK, Conn., May 21, 2014 /PRNewswire/ -- A newly published peer-reviewed study that examines Stretta ® therapy, further confirms the long-term effectiveness of this non-surgical treatment for gastroesophageal reflux disease (GERD). The 8-year study published in Gastroenterology Research and Practice, entitled "Durability of Stretta Radiofrequency Treatment for GERD: Results of 8-Year Follow-Up" corroborates the findings of another recently published long-term study on Stretta with 10-year follow-up. 

Stretta therapy delivers low power, low temperature radiofrequency energy to remodel the valve known as the lower esophageal
               sphincter (LES) at the junction of the esophagus and the stomach. Stretta reduces or eliminates regurgitation of stomach contents
               by improving muscle tone and reducing random openings of the LES that are known to cause GERD. Stretta treatment results in
               elimination or significant reductions of GERD symptoms and medication use, and significant improvement in patient quality
               of life.

The new study, authored by Drs. Luca Dughera, Maria De Cento, Paola Cassolino, and Fabio Cissaro of City of Health and Sciences Hospital, Turin, Italy, and Gianluca Rotondano of Maresca Hospital, Naples, Italy, concludes that Stretta is a safe and effective treatment with lasting results in patients for whom PPI therapy provides unsatisfactory control of GERD symptoms, and those that prefer a less invasive treatment option than surgery.

"Of the many important findings in this study, one of the most significant is the complete absence of any Barrett's esophagus or erosive esophagitis in the follow-up population at 8-years," stated Dr. Dughera. "These findings make clear that along with excellent symptom control, Stretta reduces patient dependence on medication while also reducing harmful effects of prolonged esophageal acid exposure, a principal cause of Barrett's and esophagitis. In fact, in this study 76.9 percent of patients were still off their PPIs at 8-year follow-up," said Dr. Dughera. "Stretta is a valuable non-surgical treatment option in the management of GERD," he added.

Stretta uses low power and low temperature radiofrequency (RF) energy to remodel the lower esophageal sphincter muscle, thus reducing GERD and its symptoms.

"This 8-year follow-up study adds to a growing body of long-term data, which now includes 10-year, 8-year, and three 4-year studies, as well as 30 other studies of varied length follow up, making Stretta by far the most studied non-surgical treatment for GERD," stated Will Rutan, CEO of Mederi Therapeutics, maker of Stretta. "The results in all of these long-term studies consistently show exceptional safety, effectiveness and durability of treatment," Rutan continued. In February of 2013, Stretta earned The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) strongest GRADE recommendation in their Clinical Guideline on Endoluminal GERD treatments.

Stretta will be featured in live case demonstrations at the upcoming Endolive Roma in Rome, Italy on May 22-23, www.endoliveroma.it, and at the GEEW in Brussels, Belgium on June 23-25, www.live-endoscopy.com.

For the complete study go to http://www.hindawi.com/journals/grp/2014/531907/

More information on Stretta is available at stretta-therapy.com.

ABOUT STRETTA® AND MEDERI®

Stretta is a minimally invasive, outpatient treatment for GERD that involves delivery of RF energy to the LES and gastric cardia. It is a safe and effective alternative to long-term drug therapy or surgery, and is covered by many insurance plans.

Mederi Therapeutics manufactures Stretta and Secca – innovative devices that deliver RF energy to treat digestive diseases. Mederi therapies are available worldwide.

Contact: Julia Brannan
(908) 464-2470
julia@pascalecommunications.com

Photo - http://photos.prnewswire.com/prnh/20130211/NY56794

SOURCE Mederi Therapeutics

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