American Society for Gastrointestinal Endoscopy (ASGE) Releases New Guidelines on Endoscopic Management of GERD

June 18, 2015

The American Society for Gastrointestinal Endoscopy (ASGE) has issued new Guidelines that cite Stretta as a viable treatment option for Gastroesophageal Reflux Disease (GERD).

According to the Guidelines, Stretta was seen as safe, effective and durable, specifically stating: “Adverse events were infrequent and typically minor. The technique appears to durably relieve GERD symptoms for up to 10 years in the majority of patients.” The document was prepared by the ASGE Standards of Practice Committee, approved by the ASGE Governing Board, and published in the June issue of Gastrointestinal Endoscopy.

Stretta is a minimally-invasive endoscopic treatment that delivers non-ablative radiofrequency (RF) energy to improve and restore the function of the lower esophageal sphincter muscle, thereby improving symptoms of GERD.

“The recent ASGE guideline regarding the role of endoscopy in treating GERD highlights the safety, efficacy, and durability of Stretta,” said Robert D. Fanelli, MD, MHA, Chief of Minimally Invasive Surgery and Surgical Endoscopy for The Guthrie Clinic and a member of both the ASGE Standards of Practice Committee and the SAGES Guidelines Committee. “This guideline, in concert with the previously published SAGES Clinical Spotlight Review on endoluminal reflux therapy, demonstrates support for Stretta as a treatment option for appropriately selected patients with GERD, based on rigorous reviews of the literature.”

The ASGE guidelines also state, “This technique uses RF energy delivery to the distal esophagus and appears to reduce GERD by decreasing tissue compliance and reducing transient lower esophageal relaxations.” In summary, the guideline suggests that endoscopic antireflux therapy may be considered for select GERD patients.

GERD is the most frequent outpatient GI diagnosis in the U.S. Although most patients are treated with proton pump inhibitors (PPIs), approximately 30 percent have incomplete control of symptoms on PPIs.

GERD is also a risk factor for esophageal cancer which is considered one of the fastest and deadliest cancers in the United States and western world.

Will Rutan, CEO of Mederi Therapeutics, the maker of Stretta said, “With recent studies highlighting potential issues with long-term PPI use, the timing is right for Stretta. Doctors who offer Stretta are positioned to make a difference in the quality of life of their patient by broadening treatment options for those in their care.”

Stretta Therapy is non-surgical treatment option for GERD patients who do not respond well to medications and wish to avoid surgery. Stretta has been the subject of more than 37 studies, all showing a high level of safety and efficacy.

Stretta can be an ideal option for patients whose symptoms are inadequately controlled by drug therapy or choose to avoid surgery. Unlike surgery, Stretta doesn’t alter the anatomy, so it provides a versatile treatment option that doesn’t complicate any future surgery, and can also be utilized in patients who already have had previous anti-reflux or bariatric procedures, and experience recurring GERD.

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This post is based on materials provided by Stretta Therapy.

Study Shows Stretta Therapy for GERD Improves Sphincter of the GI Tract

December 26, 2014

A newly published, pathologist-blinded study in a porcine model, examines the histopathology changes after non-ablative radiofrequency (NARF) to smooth muscle as delivered by Stretta therapy for GERD and Secca therapy for fecal incontinence. Radiofrequency therapy is commonly thought of in terms of ablation, where tissue destruction occurs. In contrast, this study shows that this unique low power, low temperature non-ablative type of radiofrequency (NARF) improves the smooth-muscle sphincters of the GI tract, as well as the skeletal muscle of the external anal sphincter. The investigation confirms multiple mechanisms that may regenerate and improve the function of the treated sphincter muscles, offering symptom improvement for patients suffering from these debilitating disorders.

The study documented the following advantages of NARF in the presence of a compromised sphincter:

  • Hypertrophy of both smooth and skeletal muscle fibers
  • Smooth muscle size and muscle bundle increase
  • Interstitial Cells of Cajal (ICCs) decrease
  • Collagen I synthesis promotion, with an increase in the Collagen I/Collagen III ratio
  • Fibrosis is diminished, due to a regression of excessive collagen deposition
  • Similar effect on Type I and II fibers as reinervation (nerve regrowth)

Study senior author Dr. Steven Wexner, Director of the Digestive Disease Center and Chairman of the Department of Colorectal Surgery at Cleveland Clinic Florida, and a paid consultant for Mederi Therapeutics Inc., commented: “The results of this study should allow us to help patients with GERD and fecal incontinence, as the regeneration we see here clarifies the mechanism of action of radiofrequency treatment.”

Learn about a new animal study showing that non-ablative radiofrequency (NARF) treatments Stretta and Secca actually regenerate muscle in the GI tract and provide relief for symptoms of GERD and fecal incontinence.

Learn about a new animal study showing that non-ablative radiofrequency (NARF) treatments Stretta and Secca actually regenerate muscle in the GI tract and provide relief for symptoms of GERD and fecal incontinence.

The randomized study was performed on an animal model of fecal incontinence with three study arms: an experimental model of fecal incontinence with damage to the sphincter muscle, which remained untreated; a group with sphincter damage, treated with NARF; a control group without a damaged sphincter and without treatment. After 10 weeks the treated tissue was excised and preserved. The resulting H&E and trichrome slides were examined by two pathologists, who were blinded to the tissue sample origin.

Study principal author Dr. Mariana Berho, Director of the Pathology and Laboratory Medicine Center and of the Center for Research at Cleveland Clinic Florida and a paid consultant for Mederi Therapeutics Inc. explained:  “The results of this animal model study are extremely valuable as they may reflect the changes that take place in the human lower esophageal sphincter as well as the internal anal sphincter after the administration of radiofrequency.”

This investigation concluded that non-ablative radiofrequency application appeared to induce profound morphological changes in the sphincter muscle that lead to an anatomical state reminiscent of the baseline sphincter structure. Further, the regeneration of muscle explains how NARF therapies, Stretta and Secca work to improve the symptoms that accompany GERD and fecal incontinence.

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SOURCE: Mederi Therapeutics Inc.