MANSFIELD, Mass. -- NDO Surgical today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the Plicator, an endoscopic, full-thickness plication device for the treatment of gastroesophageal reflux disease (GERD). The market for GERD treatment exceeds $9.3 billion each year in the United States.
The Plicator is designed to provide a lasting solution to GERD through a simple outpatient procedure. Because the system is passed transorally, no surgical incisions are required. Using direct endoscopic visualization throughout the procedure, the Plicator secures and fixates tissue at the gastroesophageal junction to restore the natural anti-reflux barrier.
Douglas Pleskow, MD, of Beth Israel Deaconess Medical Center in Boston was the principal investigator for a seven-site, 64 patient U.S./Canadian clinical study evaluating the safety and efficacy of the Plicator procedure. "Typically, procedures took 20 minutes or less, with patients going home within a few hours of treatment," says Pleskow. "Thus far, we've been encouraged by our results, with most patients experiencing symptom relief while discontinuing their daily prescription medications for heartburn."
More than 15 million Americans suffer from chronic, daily heartburn, the most common symptom of GERD. Current treatment options for GERD range from prescription medications to laparoscopic surgery. While medications can relieve heartburn, they often require a life-long regimen and do not treat the underlying mechanical defect that is present in patients with GERD.
"FDA clearance of the Plicator System is an important step forward in the treatment of GERD," says Michael D. Laufer, MD, founder and chief executive officer, NDO Surgical. "Physicians can offer their patients a less invasive treatment for GERD that is based upon the proven principles of anti-reflux surgery, while reducing overall healthcare system costs. The Plicator represents a next generation endoscopic technology for GERD by providing doctors with a tissue based procedure that is safe and intuitive."
For more information, visit www.ndosurgical.com .