– Quality of Evidence: (++++)
– Grade Recommendation: Strong (Highest)
GREENWICH, Connecticut, Feb. 11, 2013 /PRNewswire – Mederi Therapeutics Inc. today announced that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has issued new Clinical Guidelines that strongly recommend Stretta therapy for the treatment of Gastroesophageal Reflux Disease (GERD). The SAGES Clinical Spotlight Review (CSR) process entails an in-depth analysis of the available peer-reviewed clinical evidence, focusing on randomized, controlled studies, as well as long-term follow up showing durability of treatment effect. The clinical evidence in support of Stretta was assigned a grade of ++++, achieving the highest possible recommendation. “The new Clinical Spotlight Review for endoluminal GERD therapies strongly supports the safety and effectiveness of Stretta as illustrated through the depth of clinical data. The body of data shows unequivocally that Stretta is a valuable minimally invasive tool for the treatment of GERD,” stated Dr. Scott Melvin, current President of SAGES.
(Photo: http://photos.prnewswire.com/prnh/20130211/NY56794 )
Stretta is a minimally-invasive endoscopic treatment that delivers radiofrequency (RF) energy to remodel the lower esophageal sphincter muscle, offering significant relief of GERD symptoms. In reference to Stretta, the guidelines stated, “More than 30 peer reviewed studies, including 4 adequately powered randomized, controlled studies, a comprehensive meta-analysis and multiple prospective clinical trials have documented the safety and efficacy of the Stretta procedure. Durable treatment outcomes to at least 48 months also have been demonstrated in multiple studies, with significant reduction or elimination of medications used to treat the symptoms of GERD, as well as improvement in GERD QOL and symptom scores.” This guideline was developed under the auspices of SAGES and its various committees, and approved by the SAGES Board of Governors. “We are encouraged that insurance companies will take note of this guideline and update their coverage policies to make Stretta available to the many sufferers of GERD,” stated Bill Reynolds, Mederi’s VP of Reimbursement & Payer Strategy.
“It is extremely gratifying to have a scientific analysis of the overwhelming body of clinical evidence supporting Stretta issued by an esteemed organization such as SAGES. The grade of ‘Strong’ indicates that no further studies are necessary to validate Stretta as a safe and effective treatment for GERD,” stated Will Rutan, CEO of Mederi Therapeutics.
To access the complete SAGES Clinical Spotlight Review go to http://www.sages.org/publication/id/CSR1/.
For more information go to stretta-therapy.com.
ABOUT STRETTA®
Stretta Therapy is a minimally invasive treatment for GERD that is an effective option for patients who do not respond well to medications. Stretta involves delivery of RF to the LES and gastric cardia. Clinical studies show Stretta to be a safe, effective and durable therapeutic option. Stretta therapy does not preclude further steps with more invasive procedures if indicated.
ABOUT MEDERI®
Mederi Therapeutics manufactures and markets innovative medical devices that deliver RF energy to treat disease states affecting the digestive system. All Mederi therapies are outpatient, minimally invasive and promote rapid recovery. Mederi Therapeutics is located in Greenwich, Connecticut.
Contact: Sheila Doyle, +1-203-930-9980, sdoyle@mederitherapeutics.com