MANSFIELD, Mass., Sept. 5 /PRNewswire/ -- NDO Surgical, Inc. today announced publication of a landmark study proving the safety and efficacy of the Plicator procedure to treat gastroesophageal reflux disease (GERD). The study, published in the September 2006 issue of Gastroenterology is the largest randomized, sham-controlled trial for an endoscopic GERD therapy. The findings show the Plicator significantly reduces GERD symptoms, PPI medication use and esophageal acid exposure compared to a sham procedure. It is the first outpatient GERD procedure to significantly improve all three factors.
The 15 site study was led by Dr. Richard Rothstein at Dartmouth Hitchcock Medical Center. It involved 159 blinded patients randomly assigned to either the Plicator group or a sham treatment group which mirrored the active procedure with the exception of the deployment of the Plicator suture-based implant. The primary endpoint was a reduction in GERD symptoms based on a GERD health related quality of life questionnaire. Three months post-procedure, 65 percent of Plicator patients achieved greater than 50 percent improvement in GERD symptom score, compared to 20 percent in the control group under the per protocol analysis.
The study also showed that medication use, esophageal acid exposure, quality of life and heartburn severity were significantly improved following Plicator treatment; 62 percent of patients treated with the Plicator eliminated daily PPI medication use.
"Physicians treating patients with GERD have been awaiting solid scientific evidence demonstrating that endoscopic procedures for GERD are, in fact, a safe and effective treatment option," said Dr. Richard Rothstein, Section Chief, Gastroenterology & Hepatology, Dartmouth Hitchcock Medical Center, and Professor of Medicine at Dartmouth Medical School. "With this sham-controlled trial, the Plicator procedure is now proven to reduce PPI medication use, esophageal acid exposure, and symptoms, which sets it apart from the other endoscopic treatments that have been used to treat GERD."
"This study further validates the Plicator procedure's efficacy and safety profile," said Patricia Hennessey, Chief Commercialization Officer at NDO Surgical. "The definitive results from this research confirm that the Plicator is an effective treatment for many patients whose symptoms are not controlled by medication and who are seeking to improve their quality of life."
The Plicator procedure is a minimally invasive treatment for GERD, a disease typically characterized by chronic heartburn. The Plicator procedure may provide relief for GERD sufferers desiring an alternative or adjunct to pharmaceutical treatment. The Plicator procedure requires no surgical incisions and is performed under conscious sedation, allowing for rapid recovery.
About the Plicator
NDO Surgical's Full-Thickness Plicator is an FDA-cleared, endoscopic GERD treatment based on the proven principles of anti-reflux surgery. Through a simple, outpatient procedure, the Plicator is used to grasp, fold, wrap and fixate tissue at the junction between the esophagus and the stomach, thus tightening the valve that acts as a barrier to gastric reflux. The Plicator is the only endoscopic GERD treatment that mimics tissue restructuring performed during anti-reflux surgery. Clinical studies have shown the Plicator procedure to be effective in reducing symptoms, medication use and acid levels in the esophagus associated with GERD.
About NDO Surgical
Based in Mansfield, Mass., NDO Surgical is a privately held medical technology company dedicated to the development of innovative endoscopic technologies for gastrointestinal diseases. Additional information is available at the Company's website at http://www.plicator.com.
Jane Hauser/Andrew Law
Source: NDO Surgical, Inc.