Boston Scientific Suspends Enteryx SalesSep 28, 2005 | AP Boston Scientific Corp. has suspended sales of a treatment for acid reflux disease after more than two dozen reports of problems.
The company says it considers its Enteryx injection kit safe, but some patients have been harmed because doctors used it incorrectly.
About 3,800 patients have been treated with Enteryx, which was approved in 2003 by the
Food and Drug Administration. The treatment is a liquid polymer injected directly into the walls of esophagus. It thickens into a permanent spongy lump which is supposed to help block acid from flowing from the stomach toward the throat.
Boston Scientific's recall notice said some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing "adverse events."
The notice was posted on the company's Web site last week.
According to reports filed with the FDA, patients have suffered leakage, swelling, and ulcers in the esophagus. An elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.
The company issued a safety alert in July 2004.
The Enteryx device was touted as one of the companies promising new products and analysts initially projected several hundred million dollars in annual revenues. But the procedure has been dogged by safety questions and uncertainty about whether insurers would reimburse for the injection.
Boston Scientific sold about $5.5 million worth of Enteryx kits last year.
"That basically was touted as a potential $500 million product, and it's turned out to be a zero," Mark Landy, a medical-device analyst for Susquehanna International Group, told The Boston Globe.
Dr. Ram Chuttani, chief of endoscopy at Beth
Israel Deaconess Medical Center, said his hospital has performed 40 to 50 Enteryx procedures. He called process, technically "very demanding."
"It is quite difficult to control even in the best settings even in experienced hands, when you inject, you cannot be absolutely certain where the Enteryx is injected," he said.