Landmark Study: Meta-Analysis of 28 Studies Shows Stretta Therapy for GERD Consistently and Significantly Improves Outcomes

          Mederi Therapeutics today announced the publication of a meta-analysis of 28 studies, representing 2468 patients who received  Stretta Therapy to treat gastroesophageal reflux disease (GERD). The study entitled, " Systematic Review and Meta-Analysis of Controlled and Prospective Cohort Efficacy Studies of Endoscopic Radiofrequency for Treatment of Gastroesophageal Reflux Disease ", was published in Surgical Endoscopy. Authors included Ronnie Fass, MD, head of the Esophageal and Swallowing Center, Director of Gastroenterology and Hepatology at Metro Health Medical Center and Professor at Case Western University, and statistical expert Frederick Cahn, PhD, principal of Biomedical Strategies.

          Lead author Dr. Ronnie Fass noted, "This comprehensive analysis combined our clinical expertise with Dr. Cahn's statistical experience to produce the most thorough and objective review of currently available data. The results demonstrate that Stretta is a clinically effective and safe therapy for GERD."

          Dr. Cahn, who has more than 30 years of healthcare experience, noted the high standards of this study. "A thorough analysis of the studies, following Cochrane recommended methodology, demonstrated they are of a high quality with low risk of bias. We also noted a consistency of positive outcomes across the wide range of studies. Strengths of this meta-analysis include: up to 10-years of follow-up (average 25 months), a large number of subjects (2468), and the inclusion of 28 studies, which places this meta-analysis in the top 1% of systematic reviews and meta-analyses."

          RESULTS:

          - Significant improvement in health related quality of life
          - Significant reduction in heartburn symptoms
          - The majority of patients off proton pump inhibitors (PPIs)
          - Significant healing of erosive esophagitis
          - Significant reduction in esophageal acid exposure
          - Low adverse event rate of <1%

          Dr. Fass explained, "The results of this study show that Stretta significantly reduces GERD symptoms while also impacting the physiological parameters, such as reducing acid exposure, and healing erosive esophagitis."

          Gastroesophageal Reflux Disease (GERD) is a condition where stomach contents reflux up into the esophagus causing symptoms like heartburn and regurgitation. This reflux occurs due to a weakness in the barrier muscle between the stomach and esophagus. The most common GERD treatment is medications, usually PPIs, however, about 30 percent of patients do not get adequate relief from these medications, and others are concerned about associated long-term risks.

          Stretta applies low levels of radiofrequency (RF) energy to the lower esophageal sphincter (LES) muscle. The treatment thickens the sphincter muscle, reducing tissue compliance and transient relaxations of the LES, improving the barrier between the stomach and esophagus, and improving GERD symptoms. Stretta is a non-surgical, endoscopic treatment that offers a significantly safer and less invasive alternative to anti-reflux surgery and freedom from life-long medication.

          Recently published  health economic data demonstrate that treating GERD with Stretta results in significant cost savings to payers, compared to long-term medications or surgery. "The combination of our new meta-analysis and the economic data further support the use of Stretta as a treatment for GERD patients," Fass added.

          Bob Knarr, CEO of Mederi explained the impact of this study. "This in-depth data analysis confirms that Stretta is safe and effective in treating GERD. This new study together with the economic data make Stretta a win for patients and payers alike, improving quality of care while reducing costs."

          ABOUT MEDERI(R) AND STRETTA(R)

          Mederi manufactures innovative medical devices that use non-ablative RF energy to treat digestive diseases. Stretta has been proven safe and effective for GERD in more than 40 studies with long-term follow up of 10-years. Stretta is available worldwide.

          Mederi provided support for the statistical analysis for this study.