Stretta Procedure for GERD: Successful 10 Year Follow-Up Data Presented at Digestive Disease Week--Sustained Improvement, Long-Term Efficacy Non-Surgical Procedure Yields High Patient Satisfaction Scores; Reduced Need for Medication; No Serious Adverse Effects
ORLANDO, Fla., May 19, 2013 /PRNewswire/ -- The non-surgical Stretta® procedure employing low power and low temperature radiofrequency (RF) energy is effective in control of gastroesophageal reflux disease (GERD), and eliminates or reduces the need for medication 10 years post-procedure, according to an independent, prospective long-term assessment presented today at the Digestive Disease Week (DDW) meeting May 18-21, 2013 in Orlando, Florida.
"The sustained improvement in GERD-HRQL scores and patient satisfaction, coupled with the potential for protection against esophageal cancer validate the long-term usefulness of this safe, clinically effective and economically effective endoscopic procedure," said principal investigator Mark Noar, M.D., Director, Endoscopic Microsurgery Associates, Maryland. "Of the 99 study participants with refractory GERD followed for 10 years, 41 percent no longer required the PPI medications they were taking pre-Stretta."
Approximately 20 percent of Americans suffer the symptoms of GERD – frequent heartburn or acid reflux, burning sensation in the chest or throat or regurgitation – at least once a week, according to the National Institutes of Health.
In some adults with GERD, atypical symptoms may present, such as dry cough, asthma, or trouble swallowing rather than, or in addition to heartburn.
Some 12 million Americans who do not respond to conservative GERD management – dietary changes or drug treatment – could potentially benefit from the Stretta procedure, including those with the atypical manifestations.
10-Year Post-Stretta Data Conclusions:
- Statistically significant and sustained improvement in GERD as measured by HQRL scores, patient satisfaction, and reduced medication requirements
- Patients with variant anatomy and prior Nissen fundoplication (anti-reflux surgery) responded as well as those with normal anatomy
- Demonstrable improvement in Barrett's tissue, and in some cases disappearance of metaplasia and dysplasia
- The reduction in reflux as a result of the Stretta procedure may protect against esophageal cancer
- The 10 year results compare favorably with the results of more invasive Nissen surgery, particularly when considering the substantially reduced risk of complications with Stretta versus all anti-reflux surgery methods
SAGES Gives Stretta Its Strongest Recommendation
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recently issued new Clinical Guidelines that give Stretta therapy for the treatment of GERD its highest recommendation based on strong clinical evidence from 32 clinical trials.
"This 10 year data adds to the already robust body of long term and Level 1 data for Stretta," said Will Rutan, CEO of Mederi Therapeutics. "This extremely long-term follow up confirms what was noted in the recent SAGES guidelines for GERD treatment…that Stretta is a very safe and very effective treatment whose time has come."
Stretta is currently covered by Medicare in 12 states, nationwide by Tricare and the VA Systems, and locally by select commercial insurance carriers. Together they insure more than 36 million Americans.
DDW booth # 765
About Mederi Therapeutics
Greenwich, Connecticut-based Mederi Therapeutics manufactures and markets innovative medical devices that deliver low power, low temperature radiofrequency energy (RF) to treat digestive diseases. With recently released second generation technology, Stretta for GERD and Secca for Bowel Incontinence, featuring enhancements in safety and ease of use, are ultra-minimally invasive outpatient treatments that deliver RF to the sphincter muscles at either end of the digestive system. These therapies bridge the gap between conservative or drug therapy and invasive surgery or implants – offering effective and less complicated, and less costly alternatives. Stretta and Secca provide durable relief to symptoms and are strongly backed by numerous clinical studies showing safety and long-term effectiveness. Products are available in North America, South America, Europe, the Middle East and Asia.
SOURCE Mederi Therapeutics