FDA Reviews Boston Scientific Acid Reflux Device After DeathAug 15, 2004 | AP
The Food and Drug Administration is reviewing the death last month of an elderly woman after she was treated with a Boston Scientific Corp. device for acid reflux disease.
The FDA is also looking at injuries in six other patients treated with the Enteryx device.
The review comes as Boston Scientific grapples with a month-old recall of its lucrative drug-coated heart stent.
Nearly 100,000 Taxus and Express 2 model stents have been recalled since July 2 because of a manufacturing defect.
In the Enteryx review, the FDA is looking into whether physician technique or the device itself triggered the woman's death, which occurred when her aorta ruptured. The Enteryx device is used to inject a plastic substance into the esophagus. The substance is designed to reduce the symptoms of acid reflux disease.
"At this time there doesn't appear to be a problem with the device," FDA spokeswoman Kathleen Quinn said.
Paul Donovan, a spokesman for Boston Scientific, said the company is recommending that the product's label be changed to stress the importance of closely following directions for use.
"We are going to work closely with the FDA," Donovan said.
Boston Scientific's stock has fallen nearly 25 percent since just before the beginning of July, when the stent recalls began.
Enteryx, which costs about $1,700, has been used in about 2,000 procedures since it was introduced in April 2003.
In acid reflux disease, the contents of the stomach back up into the esophagus. Enteryx is one of a handful of minimally invasive treatments designed to offer relief without daily medication.