Sponsoring company ceased business operations.

The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.

A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.

Inclusion Criteria:

• Subject is 18 years of age or older.
• History of heartburn or regurgitation for at least 6 months.
• Esophageal manometry study (conducted within the previous 6 months) demonstrating an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
• pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH<4.0 > 4.5% or a DeMeester composite score > 14.7).
• Symptoms requiring daily PPI therapy.
• GERD-HRQL scores must be > 15 while Off Medication and Off Medication scores must be > 6 points higher than On-Medication scores.
• Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
• Subject agrees to participate and signs consent form.

Exclusion Criteria:

• Patient is pregnant.
• Patient has hiatal hernia > 3 cm.
• Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
• Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
• Barrett's esophagus with dysplasia.
• Patient has had a previous endoscopic (Endocinch, Stretta, Enteryx, etc.) or surgical repair (Nissen Fundoplication, etc.) performed to treat GERD.
• Active medical condition that would preclude the subject from finishing this study.
• Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
• Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
• Presence of esophageal or gastric varices.
• Esophageal dysmotility as determined by manometry studies.
• Esophageal stricture.