Mederi Therapeutics Inc., manufacturers of Stretta Therapy for gastroesophageal reflux disease (GERD), announced the presentation of new data at last week's Digestive Disease Week(R) (DDW) 2016 in San Diego. This new 10-year data shows efficacy of Stretta in three specific types of non-classical GERD patients: those with high BMI, those with respiratory symptoms of GERD, and those suffering from recurring GERD after anti-reflux surgery. DDW activities also included the launch of the new Stretta RFT3 system, and four presentations by international Stretta expert physicians.
10-Year Data
The data, presented by Dr. Mark Noar (The Heartburn and Reflux Study Center, Towson, MD), examined challenging GERD patient subsets that were included in his published 10-year study, and demonstrated that each of these patient populations achieved the primary outcomes of long-term symptom relief, reduced medication use, and patient satisfaction.
- Stretta is effective in the treatment of medically refractory GERD, independent of BMI. 73 patients comprising three subpopulations of BMI (Normal, Overweight, and Obese) were studied. At 10-year follow-up, regardless of BMI, all parameters demonstrated statistically significant improvement.
- Stretta is effective in laryngopharyngeal reflux (LPR). 99 refractory LPR and non-LPR patients were studied. At 10-year follow-up, all parameters demonstrated statistically significant improvement across the entire respondent cohort.
- In patients with refractory GERD after a laparoscopic Nissen fundoplication (LNF), Stretta results in sustained improvement with near equivalence and slightly better outcomes than the non-LNF cohort. 18 refractory LNF (RLNF+S) and 81 standard refractory GERD patients were studied. At 10-year follow-up, both patient subsets demonstrated statistically significant improvement in primary outcomes.
About 30% of adults suffer from chronic GERD. Many of these patients are dissatisfied with the use of proton pump inhibitors (PPIs) or are concerned about the risks associated with long-term PPI use. Many wish to avoid invasive surgery. Stretta provides a non-surgical, middle option for this patient.
Introducing – Stretta RFT3 – the RE-Generation
At DDW, Mederi unveiled new aesthetic, functional, and material improvements to further facilitate ease of use and optimize the delivery of the clinically proven Stretta therapy. These improvements include a familiar GI product color scheme, added measurement markings on the Stretta catheter, more visual procedure guides, and software changes to increase treatment automation.
Expert Physician Presentations
Stretta international experts presented updates on Stretta data as well as shared their experience. The speakers included, Dr. Alvaro Reymunde from Ponce, Puerto Rico; Dr. Hwoon-Yong Jung from Seoul, South Korea; Dr. Luca Dughera from Torino Italy and Dr. Jose de Jesus Herrera from Mexico City, Mexico. Dr. Dughera also reviewed his published 8-year data and presented pending 10-year follow-up. "A large majority of my patients remain symptom free after 10-years, GERD HRQL scores were maintained, and 71% of patients were still off medications," said Dughera. He also discussed his experience with Mederi's Stretta system. "I was one of the first users and have seen the evolution of Stretta into an extremely user-friendly system. We are now analyzing data on 200 patients who received Mederi's Stretta since 2011. The results appear superior to my published long-term data," he added.
"Mederi is committed to producing technology that improves quality of care for GERD," commented Bob Knarr, Chief Executive Officer of Mederi. "While we continue to improve Stretta, emerging data continues to validate this proven procedure and demonstrate its economic advantages . The science and economics of Stretta show continued, lasting benefits, and we look forward to bringing Stretta to more GERD sufferers around the world."
About Mederi Therapeutics Inc. and Stretta Therapy
Mederi manufactures innovative devices that use non-ablative radiofrequency (NARF) energy to treat digestive diseases. Mederi's Stretta has been proven safe and effective for the treatment of GERD in more than 40 studies. More than 20,000 Stretta procedures have been performed worldwide, and it is available in more than 40 countries.
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