The Plicator™: A Non-Surgical Treatment for Gastroesophageal Reflux Disease

The Plicator procedure is an endoscopic treatment for gastroesophageal reflux disease (GERD) — a chronic condition that occurs when the lower esophageal sphincter relaxes, allowing the contents of the stomach to flow back into the esophagus.

How It Works

The Plicator device is inserted through the mouth and down the esophagus with the help of an endoscope. The device grasps, folds, and fixates tissue with a pre-tied suture at the junction of the stomach and esophagus. This tightens the valve that acts as a natural barrier to gastric reflux.[1] Patients receive intravenous conscious sedation during the 20- to 30-minute procedure and return home the same day.

Who Might Benefit

About 13% of Canadian adults experience moderate to severe GERD symptoms at least weekly.[2] Common GERD symptoms include heartburn and regurgitation. The Plicator is intended for individuals with chronic GERD who would otherwise be treated with drugs, particularly proton pump inhibitors (PPIs), or by surgical fundoplication. While PPI therapy is largely effective, some patients experience intolerable side effects or persistent regurgitation.[3]

Regulatory Approval

The Plicator™ (NDO Surgical Inc., Mansfield, MA) received US Food and Drug Administration clearance in April 2003. It is not yet licensed in Canada.

Evidence of Effectiveness

A randomized controlled trial of 159 patients compared the Plicator against a “sham” treatment. In the Plicator group, health-related quality of life was significantly greater at three-months follow-up and more patients were able to cease PPI therapy (50% versus 24%, p<0.001) compared with those in the sham group. Esophageal acid exposure also improved compared with the sham group.[3]

In an open label trial, 36 of 53 patients (68%) who had been using PPIs daily had stopped taking this medication 12 months after the Plicator procedure.[4] At 36-months follow-up, 14 of 28 patients (50%) had discontinued PPIs.[5] Health-related quality of life scores remained significantly improved (p<0.001) compared with baseline values.[5]

No randomized trials have compared the Plicator treatment with PPIs, surgery, or other endoscopic anti-reflux devices.[6] Evidence that it is better than, or at least as good as, medical therapy is still needed.[6]

Safety

The most commonly reported adverse effects with the Plicator procedure include sore throat, radiating shoulder pain, and abdominal pain, which resolve without intervention.[3,4] Long-term adverse events were not observed in the open-label trial.[4,5] In the randomized trial, four of 78 persons (5%) in the treatment arm required hospitalization after the procedure, and another person had the plication suture removed and a fundoplication performed three months after the Plicator procedure.[3]

Cost

According to the manufacturer, the capital cost of the Plicator instrument is US$15,000. A single-use tissue retractor and implant cartridge cost US$1,800 per patient.

References

[1] The Plicator™ Procedure. In: NDO Surgical [web site]. Mansfield (MA): NDO Surgical; 2007. Available: http://www.ndosurgical.com/patient_portal/plicator_procedure.htm
[2] Armstrong D, et al. Can J Gastroenterol 2005;19(1):15-35.
[3] Rothstein R, et al. Gastroenterology 2006;131(3):704-12.
[4] Pleskow D, et al. Gastrointest Endosc 2005;61(6):643-9.
[5] Pleskow D, et al. Surg Endosc 2007;21(3):439-44.
[6] Shaheen NJ. Gastroenterology 2006;131(3):952-4.