Boston Scientific Corporation announced that the Gastroenterology and Urology Devices Panel voted unanimously to recommend to the U.S. Food and Drug Administration (FDA) the approval of Enteryx for the treatment of symptoms of gastroesophageal reflux disease (GERD) in patients who require and respond to pharmaceutical therapy. The Panel recommended approval with conditions relating primarily to a planned post-market study and language in the product labeling information for physicians and patients.
The Enteryx technology is a patented liquid polymer delivered by injection through an endoscope into the muscle of the lower esophageal sphincter. The polymer solidifies into a sponge-like material when it is injected into the tissue, supporting the lower esophageal sphincter and helping to prevent or reduce reflux of gastric acid into the esophagus. The procedure is done under intravenous sedation and can be performed as an outpatient procedure. Seventy percent of the patients treated stayed off their prescription GERD medication and an additional 10 percent had reduced their prescription dose by greater than 50 per cent throughout the course of the one-year study.
The company believes that between 10 and 15 per cent of the estimated 15 million chronic GERD sufferers in the U.S. can be served by less-invasive therapies. In 2000, $8.3 billion was spent in the U.S. on prescription drugs that treat heartburn, the primary symptom of the disease. This represents a 26 per cent increase over prescription sales in 1999.
"We are pleased with the Panel's recognition that Enteryx may be an alternative therapy to drugs or surgery for the treatment of symptoms related to GERD," said Michael Phalen, President, Boston Scientific Endoscopy. "We look forward to the FDA's final decision and the opportunity to bring this technology to the market."
"The Enteryx technology represents the commitment of Boston Scientific's Endosurgery Group to bringing interventional technologies to diseases that impact quality of life," said Steve Moreci, Boston Scientific Senior Vice President and Group President, Endosurgery. "This technology offers a less-invasive therapy for patients suffering from GERD."