Stretta Procedure

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) Stretta Procedure L34553 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L34553 LCD Title Stretta Procedure Proposed LCD in Comment Period N/A Source Proposed LCD DL34553 Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 09/01/2024 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 07/18/2024 Notice Period End Date 08/31/2024 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not pa

Abstract Gastroesophageal reflux disease (GERD) is defined by the presence of chronic symptoms or mucosal damage caused by an abnormal reflux of gastric contents into the esophagus. GERD may be caused by a weakness in the lower esophageal sphincter (LES), the presence of a hiatal hernia (HH), transient LES relaxation, alterations in the gastroesophageal pressure gradient, and esophageal factors such as poor clearance and changes in motility. Heartburn (pyrosis) and regurgitation, the most common and highly specific symptoms of GERD, may be experienced alone or in combination after eating a meal. Severe complications of GERD include the development of strictures, erosive esophagitis, and Barrett’s esophagus. The Stretta system (Mederi Therapeutics Inc., Greenwich, Connecticut) is a radiofrequency (RF) treatment for GERD. The system, including its specialized catheters and RF generators were originally cleared by the United States (U.S.) Food and Drug Administration (FDA) for use in 2000 and was issued an updated clearance on the RF generator in 2011 . The transoral Stretta catheter system uses a proprietary algorithmic application of low power (5 Watts) RF energy and generates low tissue temperatures (65°C to 85°C) during a series of 1-minute treatment cycles. The endoluminal Stretta therapy remodels (thickens) the musculature of the LES and gastric cardia. Clinical results demonstrate that the Stretta RF treatment results in significant reductions in tissue compliance and transient LES relaxations. These mechanisms act to restore the natural barrier function of the LES as well as to significantly reduce spontaneous regurgitation caused by transient inappropriate relaxations of the sphincter. Limitations An extensive literature review documented the following information: The results show that RF treatment significantly improved heartburn scores and produced significant improvements in quality of life (QOL) as measured by the GERD Health-Related Quality of Life (GERD-HRQL) scale and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. Esophageal acid exposure decreased but did not normalize, and while the procedure did not significantly increase LES pressure, there was a trend toward improvement. More than 30 peer reviewed studies, including 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 120 months have been demonstrated. In multiple studies, significant reduction or elimination of medications used to treat the symptoms of GERD, as well as improvement in GERD QOL and symptom scores have been demonstrated. Stretta may be recommended as an appropriate therapeutic option for patients with chronic GERD who meet current indications and patient selection criteria and choose endoluminal therapy over the gold standard of laparoscopic fundoplication (Noar, et al. 2014). Those criteria include: Adult patients (age ≥ 18) with symptoms of chronic GERD, heartburn, regurgitation, or both for ≥ 6 months who have been partially or completely refractory to antisecretory pharmacologic therapy. Adult patients who do not wish to continue long-term medication use or are not appropriate surgical candidates or do not wish to undergo surgery if there were a less invasive treatment option available. The procedure has not been studied and should not be applied in treating patients with severe esophagitis, hiatal hernias > 2 cm, long segment Barrett’s esophagus, dysphagia, or those with a history of autoimmune disease, collagen vascular disease, and/or coagulation disorders.