The trans-oral Stretta catheter system uses a proprietary application of RF energy that is low-power (5 Watts) and generates low temperatures (65°C to 85°C) during a series of 14 one-minute cycles which remodel the lower esophageal sphincter (LES) muscle and gastric cardia. The FDA originally cleared Stretta for use in 2000 and issued an updated clearance on the RF1 generator in 2011. Clinical studies demonstrate that Stretta RF treatment results in significant reductions in tissue compliance and transient LES relaxations, as well as increased LES wall thickness due to muscle growth. These mechanisms restore the natural barrier function of the LES and reduce spontaneous regurgitation caused by transient relaxations of the sphincter, two of the leading causes of GERD. Stretta is typically performed on an outpatient basis with conscious sedation.