RCT shows Stretta wins over PPI, and new coverage policy issued by Capital Blue Cross in PA
NORWALK, Conn., Nov. 8, 2017 /CNW/ -- Mederi is pleased to announce publication of a new randomized, controlled trial as well as additional insurance coverage for Stretta Therapy, a treatment for Gastroesophageal Reflux Disease (GERD).
GERD is a common disease affecting about 30% of the population. Standard GERD treatment with proton pump inhibitors (PPIs) is ineffective in more than 20% of patients, and recent studies have linked long-term PPI use to a variety of potential complications. Stretta provides an option when patients don't respond to PPIs, or are concerned about their side effects and want to avoid surgery. Stretta is performed endoscopically, in an outpatient setting.
New Stretta Data:
An interim analysis of a randomized controlled trial was recently published in the October 2017 issue of the Indian Journal of Gastroenterology. The clinical trial was performed at the Asian Institute of Gastroenterology in Hyderabad India, and authors included Dr. Rakesh Kalapala and Dr. Nageshwar Reddy. The study compared Stretta to PPI treatment at 3-month follow-up. The results showed that 80% of patients had significant improvement in GERD symptoms (heartburn, regurgitation and chest pain) and quality of life after Stretta vs 40% of the PPI control group. Additionally 80% of the patients were satisfied with their Stretta treatment vs 30% of those on PPIs, and at 3-months after Stretta 60% were completely off PPIs, with no change to the control group.
Stretta uses non-ablative levels of radiofrequency (RF) energy to treat the weak muscle between the stomach and esophagus that may cause GERD symptoms. The mechanism of Stretta has been shown to be a thickening of this muscle and decreased tissue compliance. These actions augment the barrier to reflux and significantly improve GERD symptoms. Studies show that the continued improvements after Stretta progress for 6-9 months post-procedure.
This new Stretta data is consistent with previously published studies, which conclude that Stretta is safe and effective over the short- and long-term. Recently, 15-year Stretta data was presented during the American College of Gastroenterology meeting, and a large meta-analysis was published including 28 studies and 2,468 patients, with follow-up ranging from 3-120 months.
New Insurance Coverage:
Effective September 1, 2017, Capital BlueCross issued a positive policy on Stretta finding it medically necessary for GERD treatment. Capital serves 21 counties in central Pennsylvania and the Lehigh Valley. Coverage for Stretta now reaches across the entire state of PA, with positive policies previously issued by Highmark BCBS in Western and Eastern PA. In addition, Stretta is covered by multiple BCBS plans, other private insurers, as well as some Medicare plans. These policies allow access to Stretta for tens of millions of patients across the U.S.
MEDERI® AND STRETTA®
Mederi manufactures innovative medical devices that use radiofrequency (RF) energy to treat digestive diseases. Mederi's Stretta Therapy has been proven safe and effective for GERD in more than 40 studies and is available worldwide.
For more information visit stretta-therapy.com.
Sheila Doyle, VP Marketing
SOURCE Mederi Therapeutics Inc.