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The GERDX®-System is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The GERDX-System is a sterile application and suture system indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy. The GERDX-System consist of following procedural components: GERDX-Applicator, GERDX-Tissue Retractor, GERDX-Suture System and the GERDX-Guide Wire. The Suture System and the Tissue Retractor are loaded onto the Applicator. The Guide Wire is placed within the antrum of the stomach by standard procedure. By use of the Guide Wire, the Applicator is introduced orally and advanced through the esophagus into the stomach. After removing the Guide Wire a thin profile gastroscope is inserted into a channel within the Applicator and the Applicator is positioned under direct endoscopic visualization at the target location within the gastrointestinal (GI) tract. The Tissue Retractor is advanced out of the distal tip of the Applicator. Gastric tissue is engaged by the Tissue Retractor and withdrawn into the Applicator, thereby pulling the tissue into the open arms of the Applicator. The arms of the Applicator are then closed to grasp and approximate the target tissue. The Suture System is then deployed to transmurally affix the GI tissue. The procedure is repeated to deploy additional Suture Systems if necessary. The number of Suture Systems that are placed will vary based on patient anatomy and physician's judgement. Parts of the Suture System remain within the patient.