GERD Implant Technology Approved
NDO Surgical, Incorporated received the FDA’s marketing blessing for the newest iteration of their Plicator implant device, used to treat patients with gastroesophageal reflux disease (GERD) that is not responsive to standard treatment protocols. News of the FDA approval was posted on the NDO website.
The Plicator II is an endoscopic-based method to treat GERD based on the approaches employed during anti-reflux surgery. This approach, however, is nonsurgical. This treatment allows the physician to restore the normal activity of the gastric cardia. This, in turn, restores the body’s natural barrier against reflux. The procedure can be completed on an outpatient basis.
The procedure using the Plicator is completed by endoscopic advancement of the Plicator II to the GE junction. The device opens and a retractor is released into the serosa, which retracts the gastric wall. The arms of the device are then closed and a suture that is already prepared is released into the full thickness serosa to serosa plication. The plication then restores normal anti-reflux activity.
Data submitted to the FDA for the new approval was collected from a small trial of 40 patients treated at a variety of centers. 80 percent of the patients who underwent treatment with the Plicator II had better GERD control compared to patients who received the standard of care, proton pump inhibitor oral therapy.
Over 15 million patients carry a diagnosis of GERD. Current medication therapies do not provide relief for all patients. GERD results when acid and stomach contents flow back into the esophagus. Patients develop tissue damage and symptoms such as heartburn.
September 25, 2007 Related topics: Product Approval & Certification, Gastroenterology